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
August 10, 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 Q2 and First Six Months 2015 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: August 10,
2015 |
By: /s/ Horst G. Zerbe |
|
------------------- |
|
Horst G. Zerbe |
|
President and Chief Executive Officer
|
IntelGenx Reports Q2 and First Six Months 2015 Results and
Provides Corporate Development Update
- Revenue up threefold over Q2 and H1 2014
- Company achieves $3M milestone payment from Edgemont
- André Godin, CPA, CA, appointed as Executive Vice-President and CFO
- Clemens Mayr, appointed Director
- Moving towards positive cash flow by fiscal year-end
SAINT LAURENT, QUEBEC, August 10, 2015 - IntelGenx
Technologies Corp. (TSX-V: IGX) (OTCQX: IGXT) (the Company or IntelGenx)
today announced financial results for the three and six months ended June 30,
2015 and provided an update on operational developments. All amounts are in U.S.
Dollars unless otherwise stated.
Sales of Forfivo XL® continue to grow as expected,
with Q2 2015 ($585 thousand) gross sales coming in more than three times higher
than in Q2 2014 ($160 thousand), commented Dr. Horst G. Zerbe, President and
CEO of IntelGenx. Furthermore, in July 2015 we were informed by our licensing
partner, Edgemont Pharmaceuticals (Edgemont), that cumulative net trade sales
of Forfivo XL® over the preceding 12 months exceeded $7 million. This
triggers a one-time milestone payment of $3 million, of which $1 million is
payable immediately and the balance six months later.
Financial Results:
Revenue for the six months ended June 30, 2015 was $1,210
thousand, up threefold over the $382 thousand realized in the first six months
of 2014. Current year sales relate exclusively to Forfivo XL®, our
first FDA approved product launched in October 2012 under a licensing
partnership with Edgemont. Revenues include $784 thousand of license revenue
compared to $201 thousand for the first six months of 2014 and $426 thousand of
royalty income compared to $181 thousand for the first six months of 2014.
Management continues to believe that year-over-year quarterly sales increases
will be maintained throughout fiscal 2015.
Operating costs and expenses remained stable at $1,456 thousand
during the first six months of 2015, versus $1,450 thousand for the
corresponding period of 2014.
IntelGenx generated an operating loss of $246 thousand during
the first six months of 2015, compared with an operating loss of $1,068 thousand
during the first six months of 2014.
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The net loss was $328 thousand for the first six months of
2015, down from $1,056 thousand during the first six months of 2014. This
translated into a $0.01 loss per share for the first six months of 2015,
compared with a loss per share of $0.02 for the first six months of 2014.
I am pleased to report that we are making significant progress
reaching our objective of positive cash flow by the end of our current fiscal
year, highlighted Mr. Andre Godin, newly appointed Executive Vice-President and
CFO of IntelGenx. Going forward, we will continue to maintain strong financial
discipline as we further enhance working capital and build on our growth
initiatives," he added.
Cash on hand as at June 30, 2015 was $2,663 thousand compared
with cash of $4,399 thousand as at December 31, 2014.
Corporate Development Update
Executive nomination
On July 20, 2015, the Company announced that it entered into an
employment agreement with André Godin, CPA, CA, appointing him Executive
Vice-President and Chief Financial Officer effective August 24, 2015. The Board
appointed Mr. Godin as Chief Financial Officer effective July 20, 2015.
Mr. Godin has more than 25 years experience in the
Biotech/Pharma industry. Most recently, he served as Interim CEO and CFO of
Neptune Technologies and Bioresources Inc. and both of its subsidiaries Acasti
and NeuroBioPharm. He started with Neptune in 2003 as Vice President,
Administration and Finance and was named its Chief Financial Officer in 2008.
Prior to joining Neptune, Mr. Godin was president of a dietary supplement
corporation and a corporate controller for a pharmaceutical corporation in OTC
products.
Mr. Godin is a member of the Canadian Chartered Professional
Accountants and the Canadian Institute of Chartered Accountants. He holds a
Bachelor of Business Administration degree from Université du Québec à
Montreal.
Appointment of new Director
On August 5, 2015, the Company announced that Clemens Mayr has
accepted his appointment to serve on the Companys Board of Directors.
Clemens Mayr is a partner of McCarthy Tétrault LLP, a leading
Canadian law firm. His practice focusses on M&A and capital markets, both
domestic and cross-border. In the course of his practice he has advised corporations and boards in numerous
industries, including in particular life-sciences and technology. He currently
also serves on the board of partners of McCarthy Tétrault LLP and on the board
of directors of the Institute of Corporate Directors (Quebec Chapter). He is
also the chair of the Legal Advisory Committee of the AMF (the Québec securities
regulatory authority).
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Product-related
Forfivo XL Sales
According to Symphony Health Solutions, gross sales of Forfivo
XL® totaled $4.7 million in the second quarter of 2015, representing
an increase of $0.74 million, or 19%, over the $4.0 million realized in the
first quarter of 2015. In addition, the number of Forfivo XL®
prescriptions filled increased by 10%, up from approximately 10,600 in the first
quarter of 2015 to 11,700 in the second quarter of 2015.
Milestone Payments
IntelGenx licensing partner Edgemont has informed the Company
that in the month of July 2015, cumulative net trade sales of Forfivo
XL® over the preceding 12 months exceeded $7 million. Under the
License and Asset Transfer Agreement that the companies entered into in 2012,
IntelGenx is entitled to a one-time milestone payment of $3 million, of which $1
million will be payable 14 days after the milestone has been achieved, and the
balance of $2 million payable six months later.
Tadalafil Oral Film
In July 2015, IntelGenx received the results of a pilot
biostudy that was conducted with the Companys proprietary VersaFilm tadalafil
product. Tadalafil is indicated for the treatment of erectile dysfunction. The
study results confirmed that the film is bioequivalent with the brand product,
Cialis® tablets. The company plans to submit a 505(b)(2) NDA in 2016
and have the product ready for commercialization upon expiry of the substance
patent in 2017.
New Manufacturing Facility
The Investments related to the Company's planned expansion are
on track. Excellent progress is being made establishing the Companys
manufacturing facility for its growing portfolio of VersaFilm projects. The
construction and build-out of the new facility is well under way and IntelGenx
expects to move into its new premises in the third quarter of 2015. The Company
looks forward to taking the next steps to position IntelGenx as the film
development partner of choice, offering its pharmaceutical partners complete support
from concept, through research and development, regulatory affairs, and
commercial supply of its VersaFilm products.
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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 including but not limited to
sales projections, timing for the completion of the new premises, and timing for
submission of the NDA and commercialization of the Companys VersaFilm
tadalafil product and these statements 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.
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INVESTOR CONTACT:
COCKRELL GROUP
Rich Cockrell
877-889-1972
investorrelations@thecockrellgroup.com
cockrellgroup.com
COMPANY CONTACT:
Andre Godin
Executive
Vice-President and CFO
IntelGenx Technologies Corp.
T: +1 514-331-7440
(ext. 201)
F: +1 514-331-0436
andre@intelgenx.com
www.intelgenx.com
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