UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C.
20549
FORM 8-K
Current Report
Pursuant to Section 13 or 15(d) of
the
Securities Exchange Act of 1934
May 14, 2015
Date of Report (Date of Earliest Event
Reported)
IntelGenx Technologies Corp.
(Exact Name of Registrant as Specified in its Charter)
Delaware
|
000-31187 |
870638336 |
(State or other jurisdiction of |
(Commission File |
(IRS Employer Identification |
incorporation) |
Number) |
No.) |
6425 Abrams,
Ville St- Laurent, Quebec, Canada |
H4S
1X9 |
(Address of principal executive offices) |
(Zip Code) |
Registrant's telephone number, including area code: (514)
331-7440
Check the appropriate box below if the Form 8K fining is
intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
[ ] Written communications pursuant to Rule 425 under the
Securities Act (17CFR230.425)
[ ] Soliciting material pursuant to Rule
14a-12 under the Exchange Act (17CFR 240.14a -12)
[ ] Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d
-2(b))
[ ] Pre-commencement communication pursuant to Rule 13e-4(c)
under the Exchange Act (17 CFR 240.13e -4(c))
Item 8.01 Other Events - News Release
IntelGenx Reports Q1, 2015 Annual Results and Provides
Corporate Development Update
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
INTELGENX TECHNOLOGIES CORP.
Dated: May 14, 2015 |
By: /s/ Horst G.
Zerbe
|
|
Horst G.
Zerbe |
|
President
and Chief Executive Officer |
Exhibit 99.1
IntelGenx Reports Q1, 2015 Results and Provides
Corporate Development Update
SAINT LAURENT, QUEBEC, May 14, 2015 - IntelGenx
Technologies Corp. (TSX-V: IGX) (OTCQX: IGXT) (the Company or IntelGenx)
today announced financial results for the three months ended March 31, 2015 and
provided an update on operational developments. All amounts are in U.S. Dollars,
unless otherwise stated.
Commenting on the results, Dr. Horst G. Zerbe, President and
CEO of IntelGenx said I am very pleased to report that we generated an
operating profit in the first quarter of 2015, which is ahead of internal
forecasts and confirms that IntelGenx is on track for its first fiscal year of
profitability. Sales of Forfivo XL continue to grow as expected, with Q1, 2015
gross sales almost three times higher than in Q1, 2014.
Investments related to our planned expansion are also on track
and we made excellent progress towards establishing a manufacturing facility for
our growing portfolio of VersaFilm projects. We recently announced the signing
of a lease agreement for 17,000ft² of new premises, negotiated a CAD$2.9 million
construction agreement for leasehold improvements in these new premises, and
placed purchase orders for VersaFilm manufacturing equipment totaling
approximately CAD$2.2 million. In fact, construction and build-out of our new
facility is already well under way. As previously announced, we plan to finance
the project from cash in hand and a government-backed bank financing of up to
CAD$3.5 million with BMO Bank of Montreal. We are looking forward to moving into
our new premises in the third quarter of 2015 and to taking the next steps to
position IntelGenx as the film development partner of choice, offering our
pharmaceutical partners complete support from concept, through research and
development, regulatory affairs, and commercial supply of our VersaFilm
products.
Financial Results:
Cash on hand as at March 31, 2015 was $3,819 thousand compared
with cash of $4,399 thousand as at December 31, 2014. The decrease of $580
thousand during the first three months of 2015 relates to the net effect of cash
used in operating activities of $279 thousand (Q1, 2014: $588 thousand), cash
used in investing activities of $384 thousand (Q1, 2014: $105 thousand), and an
unrealized foreign exchange loss of $312 thousand (Q1, 2014: $210 thousand),
partly offset by cash provided by financing activities of $395 thousand (Q1,
2014: $1,064 thousand). The net cash provided by financing activities during the
first quarter of 2015 derives from the first tranche of a term loan in the
amount of CAD$500 thousand negotiated with BMO Bank of Montreal, whereas the
cash provided during the first quarter of 2014 related to the exercise of
warrants.
Accounts receivable totaled $76 thousand as at March 31, 2015
compared with $652 thousand as at December 31, 2014. The accounts receivable
balance at December 31, 2014 included an amount of $600 thousand that was
invoiced to our commercialization partner for Forfivo XL®, Edgemont
Pharmaceuticals LLP (Edgemont), in the fourth quarter of 2014. Payment against
the invoice was received in February 2015.
Revenue for the three months ended March 31, 2015 increased
almost threefold to $625 thousand, compared with $222 thousand for the first
three months of 2014. Revenue recorded in the first quarter of 2015 relates
exclusively to Forfivo XL®, our first FDA approved product launched in October
2012 under a licensing partnership with Edgemont, and includes $391 thousand of
license revenue (Q1, 2014: $125 thousand) and $234 thousand of royalty income
(Q1, 2014: $97 thousand). Management continues to believe that the
quarter-over-quarter increase of gross sales will continue throughout fiscal
2015.
Operating costs and expenses decreased from $664 thousand
during the first three months of 2014 to $610 thousand during the first three
months of 2015. The decrease primarily relates to a foreign exchange gain of $84
thousand arising from the strengthening of the US dollar versus the Canadian
dollar between Q1, 2015 and Q1, 2014.
IntelGenx generated an operating profit of $15 thousand during
the first three months of 2015, compared with an operating loss of $442 thousand
during the first three months of 2014.
The net loss decreased from $442 thousand during the first
three months of 2014 to a loss of $54 thousand during the first three months of
2015, and the loss per share was $0.00 for the first three months of 2015,
compared with a loss per share of $0.01 for the first three months of 2014.
Corporate Development Update
Product-related
Anti-depressant tablet, Forfivo XL®
On February 23, 2015 we provided an update on sales and
marketing activities for Forfivo XL®, our first FDA-approved product that was
launched in the USA in October 2012 under an exclusive commercialization
agreement with Edgemont.
According to Symphony Health Solutions, gross sales of Forfivo
XL® totaled $8.9 million in the year ending December 31st, 2014, compared with
sales of $2.7 million in the preceding year. The number of Forfivo XL®
prescriptions filled increased from approximately 13,617 in 2013 to 30,378 in
2014. The average month-on-month growth rate of Forfivo XL® throughout 2014
exceeded 9%.
Forfivo XL® is indicated for treatment of Major Depressive
Disorder (MDD) and is the only extended-release bupropion HCl product to provide
a once-daily, 450mg dose in a single tablet. The active ingredient in Forfivo
XL® is bupropion, the same active ingredient used in the well-known
antidepressant product: Wellbutrin XL®.
Corporate
New Manufacturing Facility with increased R&D and
Administration space
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). The Lease has a 10 year and 6 month term
commencing 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 are will be required to pay base rent of approximately CAD$110
thousand (approximately $87 thousand) per year, which will increase at a rate of
CAD$0.25 ($0.20) per square foot every two years. We plan to use the newly
leased space to manufacture our oral film VersaFilm products, to enlarge our
research and development capabilities, and for administration purposes.
On April 29, 2015 we entered into an agreement for the
construction of manufacturing facilities, laboratories, and offices within the
property located at 6420 Abrams, St-Laurent, Quebec, at an aggregate cost of
CAD$2.9 million (approximately $2.3 million). The construction agreement was
awarded to BTL Construction Inc. (BTL) in Quebec following a tender process
that was completed in December 2014. BTL specializes in the renovation of
existing buildings for pharmaceutical use and has completed projects for various
major pharmaceutical companies. We plan to fund this project from cash on hand.
Construction is anticipated to be completed in Q3, 2015.
On March 16, 2015 we received CAD$500 thousand (approximately
$430 thousand) in cash as part of a credit facility of up to CAD$3.5 million
(approximately $3.0 million) negotiated with BMO Bank of Montreal (BMO). The
credit facility is supported by a 50% guarantee under the Export Guarantee
Program from Export Development Canada, Canadas export credit agency.
Management expects disbursement of the remaining CAD$3.0 million ($2.6 million)
to follow after BMO has reviewed (in August 2015) our operating results for the
first 6 months of 2015. The credit facility may be drawn down in multiple
disbursements over 12 months and, after a 6 month moratorium on the capital, has
a repayment term of up to 60 months. The financial covenants of the credit
facility require us to maintain a Minimum Debt Service Coverage ratio of 1.25:1,
and a Maximum Total Debt to Tangible Net Worth ratio of 2.5:1. Based upon
Managements business forecasts and projections, Management believes that we
will be able to fully comply with these financial covenants. We intend to use
the funds for the purchase and installation of new equipment for our new,
state-of the-art, manufacturing facility.
On March 16, 2015 we placed an order for 2 packaging machines
to be manufactured by Harro Höfliger Verpackungsmaschinen GmbH (Harro
Höfliger) and installed in our new, state-of the-art, manufacturing facility.
Harro Höfliger is widely recognized as a high end supplier of production and
packaging equipment, primarily to the pharmaceutical and medical device
industries, and is noted for providing innovative, custom equipment to meet the
needs of customers. Our purchase order consists of one commercial grade
packaging machine and one smaller machine for our R&D laboratories. The
purchase order, in the aggregate amount of approximately €1.5 million
(approximately $1.6 million), requires immediate payment of a 20% deposit with a
further 70% to be paid upon delivery of each machine and the balance of 10% to
be paid upon satisfactory completion of a Site Acceptance Test of each machine.
The packaging machine for our R&D laboratories is expected to be delivered
in Q3, 2015 and the commercial grade packaging machine is expected to be
delivered in Q4, 2015. We intend to finance the acquisition of these 2 machines
with the credit facility negotiated with BMO, as discussed above.
About IntelGenx:
IntelGenx is a drug delivery company focused on the development
of oral controlled-release products as well as novel rapidly disintegrating
delivery systems. IntelGenx uses its unique multiple layer delivery system to
provide zero-order release of active drugs in the gastrointestinal tract.
IntelGenx has also developed novel delivery technologies for the rapid delivery
of pharmaceutically active substances in the oral cavity based on its experience
with rapidly disintegrating films. IntelGenx' development pipeline includes
products for the treatment of indications such as severe depression,
hypertension, erectile dysfunction, migraine, insomnia, CNS indications,
idiopathic pulmonary fibrosis, oncology and pain, as well as animal health
products. More information is available about the company at www.intelgenx.com.
Forward Looking Statements:
This document may contain forward-looking information about
IntelGenx' operating results and business prospects that involve substantial
risks and uncertainties. Statements that are not purely historical are
forward-looking statements within the meaning of Section 21E of the Securities
Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933,
as amended. These statements include, but are not limited to, statements about
IntelGenx' plans, objectives, expectations, strategies, intentions or other
characterizations of future events or circumstances and are generally identified
by the words "may," "expects," "anticipates," "intends," "plans," "believes,"
"seeks," "estimates," "could," "would," and similar expressions. All forward
looking statements are expressly qualified in their entirety by this
cautionary statement. Because these forward-looking statements are subject to a
number of risks and uncertainties, IntelGenx' actual results could differ
materially from those expressed or implied by these forward looking statements.
Factors that could cause or contribute to such differences include, but are not
limited to, those discussed under the heading "Risk Factors" in IntelGenx'
annual report on Form 10-K for the fiscal year ended December 31, 2014, filed
with the United States Securities and Exchange Commission and available at
www.sec.gov, and also filed with Canadian
securities regulatory authorities and www.sedar.com. IntelGenx assumes no obligation to
update any such forward-looking statements.
Each of the TSX Venture Exchange and OTCQX has neither
approved nor disapproved the contents of this press release.
INVESTOR CONTACT:
COCKRELL GROUP
Rich Cockrell
877-889-1972
investorrelations@thecockrellgroup.com
cockrellgroup.com
COMPANY CONTACT:
Horst G. Zerbe
President and
CEO
IntelGenx Technologies Corp.
T: +1 514-331-7440 (ext. 201)
F: +1
514-331-0436
horst@intelgenx.com
www.intelgenx.com
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