IntelGenx Technologies Corp. (TSX:IGX) (OTCQB:IGXT) (the
"Company" or "IntelGenx") today reported financial results for the
third quarter ended September 30, 2021. All dollar amounts are
expressed in U.S. currency, unless otherwise indicated, and results
are reported in accordance with United States generally
accepted accounting principles except where noted otherwise.
2021 Third Quarter Financial
Summary:
- Revenue
was $593,000, compared to $510,000 in the 2020 third
quarter.
- Net
comprehensive loss was $2.2 million, compared to $1.6 million in
Q3-2020.
- Adjusted EBITDA
loss was $1.4 million, compared to $1.2 million in
the 2020 third quarter.
Third Quarter and Recent
Developments:
- Resumed patient
screening in the ongoing ‘BUENA’ Montelukast VersaFilm® Phase 2a
clinical trial in patients with mild to moderate Alzheimer’s
Disease (“AD”) following Health Canada’s issuance of a No Objection
Letter in response to the Company’s amended Clinical Trial
Application.
- Graduated to the
Toronto Stock Exchange.
- Announced that
its co-development and commercialization partner for Tadalafil oral
films for the treatment of erectile dysfunction (ED) and benign
prostatic hyperplasia (BPH), Aquestive Therapeutics, Inc.
(NASDAQ:AQST), entered into a definitive license and supply
agreement with an undisclosed leading men’s health company.
- Announced that
atai Life Sciences AG (“atai”) committed $6.0 million in future
financial support to IntelGenx via amendments to the loan facility
between the parties.
- Announced that
Exeltis Healthcare S.L., the Company’s commercialization partner in
the European Union for RIZAPORT®, a unique treatment for acute
migraines, launched the product in Spain.
- Completed an
initial shipment of CBD Filmstrips in support of Heritage Cannabis
Holdings Corp.’s (CSE:CANN) Canadian market launch of its “CB4
Control” branded product.
- Closed a $2.1
million private placement of 8% convertible notes due July 31,
2025, which the Company intends to use to finance its BUENA trial
of Montelukast in AD.
- Increased the
size of the Board of Directors from six to eight with the
appointments of Srinivas (Srini) G. Rao, M.D., Ph.D. and Frank
Stegert.
"The past few months have been a very productive
and exciting period for IntelGenx, marked by the achievement of
five major milestones,” commented Dr. Horst G. Zerbe, CEO
of IntelGenx. “Our graduation to the TSX, Canada’s most senior
exchange, came on the heels of our successful transition from a
development-stage to a commercial-stage leader in pharmaceutical
films as well as our transformational partnership with atai. We
were also pleased to resume patient screening in our ongoing
‘BUENA’ Montelukast VersaFilm Phase 2a clinical trial in patients
with mild to moderate AD. Having executed on many elements of our
growth strategy this quarter, we look forward to continuing to
advance our portfolio of innovative film products and product
candidates.”
Financial Results:
Total revenues for the three-month period
ended September 30, 2021 amounted to $593,000, an
increase of $83,000, or 16%, compared to $510,000 for the
three-month period ended September 30, 2020. The change is
mainly attributable to increases in sales milestone revenues of
$320,000, product revenues of $70,000, partially offset by a
$308,000 decrease in revenues from licensing agreements.
Operating costs and expenses were $2.2 million
for the third quarter of 2021, versus $1.9 million for the
corresponding three-month period of 2020. The increase for the
three-month period ended September 30, 2021 is mainly attributable
to increases of $26,000 in R&D expense, $255,000 in
manufacturing expenses, $37,000 in selling, general and
administrative expenses, $17,000 in depreciation of tangible
assets.
For the third quarter of 2021, the Company had
an operating loss of $1.6 million, compared to an operating loss of
$1.4 million for the comparable period of 2020.
Net comprehensive loss for the three-month
period ended September 30, 2021 was $2.2 million, or $0.01 per
basic and diluted share, compared to net comprehensive loss of $1.6
million, or $0.01 per basic and diluted share, for the comparable
period of 2020.
As at September 30, 2021, the Company's
cash and short-term investments totalled $12.0 million.
Conference Call Details:
IntelGenx will host a conference call to
discuss these third quarter 2021 financial results today
at 4:30 p.m. ET. The dial-in number for the conference call is
(888) 506-0058 (Canada and the United States) and (973) 528-0135
(International), access code 995615. The call will also be webcast
live and archived on the Company's website at www.intelgenx.com
under "Webcasts" in the Investors section.
About IntelGenx
IntelGenx is a leading drug delivery company
focused on the development and manufacturing of pharmaceutical
films.
IntelGenx’s superior film technologies,
including VersaFilm®, DisinteQ™, VetaFilm™ and transdermal
VevaDerm™, allow for next generation pharmaceutical products that
address unmet medical needs. IntelGenx’s innovative product
pipeline offers significant benefits to patients and physicians for
many therapeutic conditions.
IntelGenx's highly skilled team provides
comprehensive pharmaceuticals services to pharmaceutical partners,
including R&D, analytical method development, clinical
monitoring, IP and regulatory services. IntelGenx's
state-of-the-art manufacturing facility offers full service by
providing lab-scale to pilot- and commercial-scale production. For
more information, visit www.intelgenx.com.
Forward-Looking Information and
StatementsThis document may contain forward-looking
information about IntelGenx's 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's 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's 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's annual report on Form
10-K, filed with the United States Securities and Exchange
Commission and available at www.sec.gov, and also filed with
Canadian securities regulatory authorities at www.sedar.com.
IntelGenx assumes no obligation to update any such forward-looking
statements.
Source: IntelGenx Technologies Corp.
For IntelGenx:
Stephen KilmerInvestor Relations(647)
872-4849stephen@kilmerlucas.com
Or
Andre Godin, CPA, CAPresident and CFOIntelGenx Corp.(514)
331-7440 ext 203andre@intelgenx.com
IntelGenx Technologies Corp.
Consolidated Balance Sheet(Expressed in
Thousands of U.S. Dollars ($000’s) Except Share and Per Share
Data)(Unaudited)
|
September 30, 2021 |
December 31, 2020 |
Assets |
|
|
|
|
|
|
Current |
|
|
|
|
|
|
Cash |
$ |
6,019 |
|
$ |
1,205 |
|
Short-term investments |
|
6,013 |
|
|
1,038 |
|
Accounts receivable |
|
1,162 |
|
|
260 |
|
Prepaid expenses |
|
116 |
|
|
162 |
|
Investment tax credits receivable |
|
407 |
|
|
635 |
|
Contract asset |
|
- |
|
|
354 |
|
Security deposits |
|
204 |
|
|
407 |
|
Inventories |
|
68 |
|
|
244 |
|
Total current assets |
|
13,989 |
|
|
4,305 |
|
Leasehold improvements
and equipment, net |
|
5,348 |
|
|
5,851 |
|
Security
deposits |
|
252 |
|
|
252 |
|
Operating lease right-of-use-asset |
|
1,050 |
|
|
710 |
|
Total assets |
$ |
20,639 |
|
$ |
11,118 |
|
Liabilities |
|
|
|
|
|
|
Current |
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
2,304 |
|
|
1,989 |
|
Current portion of long-term debt |
|
- |
|
|
561 |
|
Current portion of operating lease liability |
|
248 |
|
|
141 |
|
Current portion of finance lease liability |
|
35 |
|
|
25 |
|
Deferred revenue |
|
192 |
|
|
166 |
|
Convertible notes |
|
- |
|
|
1,486 |
|
Convertible debentures |
|
5,317 |
|
|
- |
|
Total current liabilities |
|
8,096 |
|
|
4,368 |
|
|
|
|
Long-term
debt |
|
2,500 |
|
|
171 |
|
Convertible
notes |
|
3,965 |
|
|
1,505 |
|
Convertible
debentures |
|
- |
|
|
5,461 |
|
Operating lease
liability |
|
691 |
|
|
482 |
|
Finance lease
liability |
|
92 |
|
|
84 |
|
Deferred income tax liability |
|
82 |
|
|
- |
|
Total liabilities |
|
15,426 |
|
|
12,071 |
|
Contingencies |
|
|
|
|
|
|
Subsequent event |
|
|
|
|
|
|
Shareholders' equity |
|
|
|
|
|
|
Capital stock, common shares,
$0.00001 par value; 450,000,000 shares authorized; 150,627,761
shares issued and outstanding (2020: 111,429,532 common
shares) |
|
1 |
|
|
1 |
|
Additional paid-in
capital |
|
61,589 |
|
|
48,453 |
|
Accumulated deficit |
|
(55,005) |
|
|
(48,551) |
|
Accumulated other comprehensive loss |
|
(1,372) |
|
|
(856) |
|
Total shareholders’ equity (deficit) |
|
5,213 |
|
|
(953) |
|
|
$ |
20,639 |
|
$ |
11,118 |
|
|
|
|
|
|
|
|
IntelGenx Technologies Corp.
Consolidated Statement of Comprehensive
Loss(Expressed in Thousands of U.S. Dollars
($000’s) Except Share and Per Share
Data)(Unaudited)
|
For the Three-Month Period |
For the Nine-Month Period |
|
Ended September 30, |
Ended September 30, |
|
2021 |
2020 |
2021 |
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
$ |
593 |
|
$ |
510 |
|
$ |
1,041 |
|
$ |
754 |
|
Total revenues |
|
593 |
|
|
510 |
|
|
1,041 |
|
|
754 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expense |
|
874 |
|
|
848 |
|
|
1,910 |
|
|
2,300 |
|
Manufacturing expenses |
|
499 |
|
|
244 |
|
|
1,598 |
|
|
1,042 |
|
Selling, general and administrative expense |
|
662 |
|
|
625 |
|
|
2,419 |
|
|
2,167 |
|
Depreciation of tangible assets |
|
199 |
|
|
182 |
|
|
589 |
|
|
536 |
|
Total expenses |
|
2,234 |
|
|
1,899 |
|
|
6,516 |
|
|
6,045 |
|
Operating
loss |
|
(1,641) |
|
|
(1,389) |
|
|
(5,475) |
|
|
(5,291) |
|
Finance and interest
income |
|
1 |
|
|
3 |
|
|
152 |
|
|
405 |
|
Financing and interest expense |
|
(365) |
|
|
(274) |
|
|
(1,134) |
|
|
(881) |
|
Net financing and interest income (expense) |
|
(364) |
|
|
(271) |
|
|
(982) |
|
|
(476) |
|
Loss before income taxes |
|
(2,005) |
|
|
(1,660) |
|
|
(6,457) |
|
|
(5,767) |
|
Deferred income tax |
|
3 |
|
|
- |
|
|
3 |
|
|
- |
|
Net loss |
|
(2,002) |
|
|
(1,660) |
|
|
(6,454) |
|
|
(5,767) |
|
Other comprehensive
(loss) income |
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustment |
|
(175) |
|
|
40 |
|
|
(518) |
|
|
(108) |
|
Change in fair value |
|
4 |
|
|
51 |
|
|
2 |
|
|
79 |
|
|
|
(171) |
|
|
91 |
|
|
(516) |
|
|
(29) |
|
Comprehensive loss |
$ |
(2,173) |
|
$ |
(1,569) |
|
$ |
(6,970) |
|
$ |
(5,796) |
|
Basic and diluted weighted average number of shares
outstanding |
|
150,590,729 |
|
|
110,259,652 |
|
|
131,576,774 |
|
|
107,818,057 |
|
Basic and diluted loss per common share |
$ |
(0.01) |
|
$ |
(0.01) |
|
$ |
(0.05) |
|
$ |
(0.05) |
|
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