Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX:
TH) (NASDAQ: THTX), a biopharmaceutical company focused on the
development and commercialization of innovative therapies, today
reported business highlights and financial results for the third
quarter of fiscal year 2024 ended August 31, 2024 (Q3 2024). All
figures are in US dollars unless otherwise stated.
Revenue for the three- and nine-month
periods ended August 31, 2024 (in thousands of
dollars)
|
Three monthsended August 31 |
% change |
Nine months ended August 31 |
% change |
|
2024 |
2023 |
|
2024 |
2023 |
|
EGRIFTA SV® net sales |
16,687 |
13,183 |
26.6 |
% |
42,473 |
36,747 |
15.6 |
% |
Trogarzo® net sales |
5,913 |
7,672 |
(22.9 |
%) |
18,391 |
21,565 |
(14.7 |
%) |
Revenue |
22,600 |
20,855 |
8.4 |
% |
60,864 |
58,312 |
4.4 |
% |
“I am pleased to wrap up this third quarter with
a strong Adjusted EBITDA of $7.2 million and a net profit of $3.1
million,” said Paul Lévesque, President and Chief Executive Officer
at Theratechnologies. “Quarter after quarter, we have continued to
demonstrate strength on the bottom line and as such are increasing
Adjusted EBITDA guidance to $17 to $19 million dollars. EGRIFTA SV®
remains our engine of growth, recording its best performance in
recent history by capturing new patients and prescribers at an
unprecedented level over the past nine months. Considering current
trends for Trogarzo®, and as a result of the potential constrained
supply of EGRIFTA SV® anticipated in late November, we are changing
topline guidance to between $83 and $85 million. We believe that in
the first part of 2025 we will fully make up for sales not recorded
in the fourth quarter of 2024 and remain confident that any impact
on patients will be avoided.
“We have doubled down on our efforts to enter
into partnerships and to find innovative products to market, making
significant progress in both in the U.S. and in Canada. Our North
American focused strategy is clear, and we are well-positioned to
achieve our long-term objective of delivering sustained top-line
and bottom-line growth. In terms of our pipeline, we remain
committed to bringing the F8 formulation to market and have now
addressed all questions from the FDA on the sBLA related to
immunogenicity and microbiology. We expect to have the file
completed shortly with a plan to submit it to the FDA by the end of
November. In oncology, we continue to be focused on generating
results from Part 3 of our Phase 1 clinical trial of sudocetaxel
zendusortide in advanced ovarian cancer and have had no reports of
DLTs, including neuropathy and eye toxicities. One final patient
remains in the trial and we plan to share results once their
treatment is completed and all data can be analyzed.”
Recent Events:
Company Announced a Risk of a Temporary
Supply Disruption for EGRIFTA
SV® in Early 2025
On September 17, 2024, the Company announced a
risk of a temporary supply disruption for EGRIFTA SV® in early 2025
caused by an unexpected voluntary shutdown of the Company’s
contract manufacturer’s facility following an inspection by the
FDA, as well as the FDA review timeline to resume distribution of
the product. The Company has since implemented measures to
carefully manage the inventory levels of EGRIFTA SV® to meet
patient demand until mid-January 2025 and these measures will
result in a revenue shortfall for EGRIFTA SV® in fiscal year 2024.
See “Revised Fiscal 2024 Revenue and Adjusted EBITDA Guidance”
below. The manufacturer is finalizing its remediation measures and
has confirmed to the Company that it plans to resume activities by
mid-October. Based on these timelines, a batch of EGRIFTA
SV® is currently scheduled to be manufactured in the week of
October 21, 2024.
Revised Fiscal 2024 Revenue and Increased Adjusted
EBITDA Guidance
Theratechnologies anticipated Fiscal 2024
revenue guidance range is revised to between $83 and $85 million
from $87 to $90 million. The Company hereby also increases Adjusted
EBITDA guidance, a non-IFRS measure, to be between $17 and $19
million from $13 to $15 million for Fiscal 2024. This increase is
supported by the Company’s continued focus on controlling expenses,
as evidenced by the strong performance of the first three quarters
of 2024. The revised revenue guidance takes into consideration the
revenue shortfall due to the potential supply constraint of EGRIFTA
SV® in late November and the year-to-date trend of Trogarzo®
sales.
Third Quarter Fiscal 2024 Financial
Results
The financial results presented in this press
release are taken from the Company’s Management’s Discussion and
Analysis (“MD&A”) and interim consolidated financial statements
(“Interim Financial Statements”) for the three- and nine-month
periods ended August 31, 2024 (“Third Quarter Fiscal 2024”) which
have been prepared in accordance with International Accounting
Standard (“IAS”) 34, Interim Financial Reporting of International
Financial Reporting Standards (“IFRS”) as issued by the
International Accounting Standards Board (“IASB”). The MD&A and
the Interim Financial Statements can be found on SEDAR+ at
www.sedarplus.ca, on EDGAR at www.sec.gov and at www.theratech.com.
Unless specified otherwise, all capitalized terms used have the
meaning ascribed thereto in the Company’s MD&A.
Revenue
For the three- and
nine-month periods ended August 31, 2024, consolidated revenue was
$22,600,000 and $60,864,000, compared to $20,855,000 and
$58,312,000 for the same periods ended August 31, 2023,
representing a year-over-year increase of 8.4% for the third
quarter and an increase of 4.2% for the first nine months of the
fiscal year.
For the third quarter
of Fiscal 2024, net sales of EGRIFTA SV® were $16,687,000 compared
to $13,183,000 in the third quarter of fiscal 2023, representing an
increase of 26.6% year-over-year. Stronger sales of EGRIFTA
SV® in the third quarter of 2024 compared to the same period last
year were mostly the result of strong unit demand for the product,
combined with a higher net selling price than last year. Net sales
for the nine-month period ended August 31, 2024 amounted to
$42,473,000 compared to $36,747,000 in the same period in 2023,
representing growth of 15.6%.
Trogarzo® net sales in
the third quarter of Fiscal 2024 amounted to $5,913,000 compared to
$7,672,000 for the same quarter of 2023, representing a decrease of
22.9% year-over-year. Lower sales of Trogarzo® were mostly
the result of lower unit sales due to competitive pressures in the
multidrug-resistant segment of the HIV-1 market, where Trogarzo
remains an important part of the treatment arsenal but has lost
market share to market leaders in the segment.
For the nine-month
period ended August 31, 2024, Trogarzo® net sales were $18,391,000
compared to $21,565,000 in the same period in 2023.
Cost of Sales
For the three- and
nine-month periods ended August 31, 2024, cost of sales was
$4,521,000 and $14,352,000 compared to $4,967,000 and $14,569,000
for the same periods in fiscal 2023.
Cost of Sales
|
Three monthsended August 31 |
Nine months ended August 31 |
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
|
($000s) |
% of Revenue |
($000s) |
% of Revenue |
($000s) |
% of Revenue |
($000s) |
% of Revenue |
EGRIFTA SV® |
1,465 |
8.8 |
% |
1,059 |
8.0 |
% |
4,901 |
11.5 |
% |
3,285 |
8.9 |
% |
Trogarzo® |
3,056 |
51.7 |
% |
3,908 |
50.9 |
% |
9,451 |
51.4 |
% |
11,284 |
52.3 |
% |
Total |
4,521 |
20.0 |
% |
4,967 |
23.8 |
% |
14,352 |
23.6 |
% |
14,569 |
25.0 |
% |
For the nine-month
period ended August 31, 2024, EGRIFTA SV® cost of sales was
negatively affected by a $1,088,000 inventory provision ($170,000
in the comparable period of 2023) related to the manufacturing of a
batch of F8 Formulation of tesamorelin, as the F8 Formulation has
not yet been approved by the FDA for commercialization. No such
provision was taken in the three-month period ended August 31,
2024. Trogarzo® cost of sales is contractually established at 52%
of net sales, subject to periodic adjustment for returns or other
factors.
R&D Expenses
R&D expenses in
the three- and nine-month periods ended August 31, 2024, amounted
to $2,612,000 and $11,089,000 compared to $5,396,000 and
$25,141,000 in the comparable periods of Fiscal 2023. R&D
expenses in the nine-month period ended August 31, 2024 include the
accelerated depreciation ($766,000) in the second quarter of
equipment used as part of the preclinical oncology research
activities, following the decision to cease early-stage R&D
activities. R&D expenses in the three- and nine-month periods
ended August 31, 2024 were also reduced by the recognition of
Canadian federal non-refundable tax credits ($650,000).
R&D expenses(in
thousands of dollars)
|
Three monthsended August 31 |
|
Nine monthsended August 31 |
|
|
2024 |
2023 |
% change |
2024 |
2023 |
% change |
Oncology |
|
|
|
|
|
|
Laboratory research and personnel |
78 |
436 |
-82% |
1,444* |
1,424 |
1% |
Pharmaceutical product development |
60 |
67 |
-10% |
217 |
4,410 |
-95% |
Phase 1 clinical trial |
493 |
204 |
142% |
1,470 |
1,806 |
-19% |
Medical projects and education |
187 |
785 |
-76% |
691 |
3,167 |
-78% |
Salaries, benefits and expenses |
1,201 |
2,142 |
-44% |
3,815 |
7,263 |
-47% |
Regulatory activities |
367 |
366 |
- |
1,174 |
1,164 |
- |
Trogarzo® IM formulation |
- |
115 |
-100% |
26 |
965 |
-97% |
Tesamorelin formulation development |
350 |
80 |
337% |
1,402 |
1,201 |
17% |
F8 human factor studies |
5 |
534 |
-99% |
12 |
1,147 |
-99% |
Pen injector |
- |
- |
- |
- |
234 |
-100% |
European activities |
53 |
117 |
-55% |
105 |
456 |
-77% |
Travel, consultants, patents, options, others |
329 |
350 |
-6% |
973 |
1,824 |
-47% |
Restructuring costs |
185 |
509 |
-64% |
521 |
509 |
2% |
Tax credits |
(696) |
(309) |
125% |
(761) |
(429) |
77% |
Total |
2,612 |
5,396 |
-52% |
11,089 |
25,141 |
-56% |
*Including accelerated
depreciation ($766,000) of equipment used in the oncology program,
following the decision to cease R&D activities related to the
oncology program
R&D expenses in
the second quarter of 2023 were negatively impacted by a provision
of $3,042,000 related to sudocetaxel zendusortide material which
could expire before the Company is able to use it in its clinical
program. Theratechnologies recorded no such provision in the
nine-month period ended August 31, 2024. Selling
Expenses
Selling expenses
decreased to $6,307,000 and $18,375,000 for the three- and
nine-month periods ended August 31, 2024, compared to $6,728,000
and $20,021,000 for the same periods last year. The decrease
in selling expenses in the three- and nine-month periods ended
August 31, 2024, is due in large part to tighter expense control in
commercialization activities. Spending in the third quarter of
Fiscal 2024 has stabilized following the completion of cost-cutting
measures implemented in Fiscal 2023.
The amortization of
the intangible asset value for the EGRIFTA SV® and Trogarzo®
commercialization rights is also included in selling expenses. As
such, the Company recorded amortization expense of $360,000 and
$1,080,000 for the three- and nine-month periods ended August 31,
2024 compared to $675,000 and $2,153,000 in the same periods of
Fiscal 2023.
General and Administrative
Expenses
General and
administrative expenses in the three- and nine-month periods ended
August 31, 2024, amounted to $2,947,000 and $9,793,000 compared to
$3,710,000 and $11,878,000 reported in the comparable periods of
Fiscal 2023. The decrease in General and Administrative expenses is
largely due to the implementation of cost-cutting measures
announced in Fiscal 2023.
Adjusted EBITDA
Adjusted EBITDA was $7,239,000 for the third
quarter of fiscal 2024 and $12,451,000 for the nine-month period
ended August 31, 2024, compared to $2,160,000 and $(7,872,000) for
the same periods of Fiscal 2023. See “Non-IFRS and Non-US-GAAP
Measure” below and see “Reconciliation of Adjusted EBITDA” below
for a reconciliation to Net Loss for the relevant periods.
Net Finance Costs
Net finance costs for
the three- and nine-month periods ended August 31, 2024, were
$2,366,000 and $6,674,000 compared to $674,000 and $7,557,000 for
the comparable periods of Fiscal 2023. Net finance costs in the
third quarter of Fiscal 2024 included interest of $2,295,000,
versus $2,244,000 in the third quarter of Fiscal 2023. Net finance
costs in the nine-month period ended August 31, 2024 included
interest of $6,882,000 versus $5,902,000 in the nine-month period
of Fiscal 2023. During the nine-month period ended on August 31,
2023, net finance costs were also impacted by the loss on Loan
Facility modification of $2,650,000 related to the issuance of
common share purchase warrants (the “Marathon Warrants”) issued in
connection with the amendments to the credit agreement entered into
with affiliates of Marathon Asset Management (the “Credit
Agreement”).
Net finance costs for
the three- and nine-month periods ended August 31, 2024, also
included accretion expense of $366,000 and $1,122,000, compared to
$500,000 and $1,642,000 for the comparable periods in 2023.
Income Taxes
During the three- and
nine-month periods ended August 31, 2024, income tax expenses
amounted to $756,000 and $984,000, versus $126,000 and $348,000 in
the same period last year. The increase in the third quarter of
2024 over previous quarters is related to the higher net income
generated by our operations. The Company recorded Canadian federal
non-refundable tax credits in the three-month period ended August
31, 2024 ($650,000) against research and development expenses,
which largely offsets the higher income tax expense.
Net Income (Loss)
As a result of
stronger revenues and the tight management of expenses over the
past year, net income for the third quarter ended August 31, 2024,
amounted to $3,091,000 compared to a net loss of $746,000 in 2023.
For the nine-month periods ended August 31, 2024 and 2023 the
Company recorded net losses of $403,000 and $21,202,000,
respectively.
Financial Position, Liquidity
and Capital Resources
Liquidity and Going Concern
As part of the preparation of the Interim
Consolidated Financial Statements, management is responsible for
identifying events or conditions that indicate a material
uncertainty exists that casts substantial doubt on the Company’s
ability to continue to honor its obligations as they fall due
during a period of at least, but not limited to, 12 months from
August 31, 2024. If the Company concludes that events or conditions
indicate material uncertainty exists on its ability to continue as
a going concern, it must assess whether management’s plans
developed to mitigate these events or conditions address the
material uncertainty.
For the nine-month period ended August 31, 2024,
the Company generated a net loss of $403,000 (2023-net loss of
$21,202,000) and had cash flows from operating activities of
$2,606,000 (2023- negative $1,572,000). As at August 31, 2024, cash
amounted to $34,690,000 and bonds and money market funds amounted
to $4,169,000.
The Company’s Marathon Credit Agreement (as
defined in Note 7 of the Interim Financial Statements) contains
various covenants, including minimum liquidity covenants whereby
the Company needs to maintain significant cash, cash equivalent and
eligible short-term investments balances in specified accounts,
which restricts the management of the Company’s liquidity (refer to
Note 7 of the Interim Financial Statements). As at August 31, 2024,
the material covenants of the Marathon Credit Agreement include:
(i) minimum liquidity of $17,500,000; and (ii) minimum Marathon
Adjusted EBITDA targets over the most recently ended four fiscal
quarters. A breach of a covenant provides the lender with the
ability to demand immediate repayment of the Loan Facility (as
defined in Note 7 of the Interim Financial Statements) and makes
available to the lender the collateralized assets, which include
substantially all cash, bonds and money market funds which are
subject to control agreements. Although the lender has previously
waived or amended the agreement for breaches of covenants, there is
no assurance that the lender will agree to waive or amend future
covenant breaches, if any. The Company does not currently have
other committed sources of financing available to it.
On September 17, 2024, the Company announced a
risk of a temporary supply disruption for EGRIFTA SV® in early
2025 caused by an unexpected voluntary shutdown of the Company’s
contract manufacturer’s facility following an inspection by the
FDA, as well as the FDA review timeline to resume distribution of
the product. The manufacturer is finalizing its remediation
measures and has confirmed to the Company that it plans to resume
activities by mid-October. Based on these timelines, a batch
of EGRIFTA SV® is currently scheduled to be manufactured
in the week of October 21, 2024. In order to resume distribution
of EGRIFTA SV®, the Company was requested by the FDA to file a
Prior Approval Supplement (“PAS”) describing the changes made by
its manufacturer. The Company plans to file the PAS in early
November 2024. A PAS is usually reviewed by the FDA within four
months of receipt.
The Company’s ability to continue generating
revenues through the sale of EGRIFTA SV® and to be able to meet the
Marathon Adjusted EBITDA targets for a period of at least, but not
limited to, 12 months from August 31, 2024, involves significant
judgement and is dependent on the resumption of the manufacture and
distribution of EGRIFTA SV® by the end of the first quarter of
fiscal 2025, which is dependant on the release to the market of the
new batch of EGRIFTA SV®. This also involves management of
expenses to remain in compliance with the conditions of the
Marathon Credit Agreement. The Company would need to obtain the
support of the lender (including possible waivers and amendments,
if necessary) in the event of a breach of the covenants in the
Marathon Credit Agreement. Should management’s plans not
materialize, the Company may be in default under the Marathon
Credit Agreement, be forced to reduce or delay expenditures and
capital additions and seek additional alternative financing, or
sell or liquidate its assets. Portions of management’s plans are
outside of their control such as the timing of resumption of
product distribution which requires FDA approval. Therefore, there
are scenarios wherein events or conditions combine to create
material uncertainty and cast substantial doubt about the
Company’s ability to continue as a going concern.
The Interim Consolidated Financial Statements
have been prepared assuming the Company will continue as a going
concern, which assumes the Company will continue its operations in
the foreseeable future and will be able to realize its assets and
discharge its liabilities and commitments in the normal course of
business. The Interim Consolidated Financial Statements do not
include any adjustments to the carrying values and classification
of assets and liabilities and reported expenses that might result
from the outcome of this uncertainty and that may be necessary if
the going concern basis was not appropriate for the Interim
Consolidated Financial Statements. If the Company was unable to
continue as a going concern, material impairment of the carrying
values of the Company’s assets, including intangible assets, could
be required.
Analysis of cash flows
Theratechnologies ended the third quarter of
Fiscal 2024 with $34,690,000 in cash, and $4,169,000 in bonds and
money market funds. Available cash is invested in highly liquid
fixed income instruments including governmental and municipal
bonds, and money market funds.
For the three-month period ended August 31,
2024, cash flow from operating activities before changes in
operating assets and liabilities improved to $4,060,000, compared
to a cash usage of $1,270,000 in the comparable period of Fiscal
2023, or an improvement of $5,330,000.
In the third quarter of Fiscal 2024, changes in
operating assets and liabilities had a positive impact on cash flow
of $544,000 (2023-positive impact of $6,599,000). These changes
included positive impacts from lower accounts receivable
($2,539,000) and from a decrease in prepaid expenses and deposits
($511,000), and also include a negative impact from lower accounts
payable ($2,329,000) and higher inventories ($455,000).
During the third quarter of Fiscal 2024, cash
flows from financing activities used $1,868,000 in cash, mostly
related to the payment of the first of 36 monthly payments
($1,683,000) related to the amortization of the Marathon loan,
while investing activities generated $779,000 from the sale bonds
and money market funds. During the nine-month period ended August
31, 2024, investing activities also include cash used for the
payment of the second milestone to TaiMed Biologics related to the
approval of the IV push method of administration of Trogarzo®
($1,500,000).
Non-IFRS and Non-U.S. GAAP Measure
The information presented in this press release
includes a measure that is not determined in accordance with IFRS
or U.S. generally accepted accounting principles (“U.S. GAAP”),
being the term “Adjusted EBITDA”. “Adjusted EBITDA” is used by the
Company as an indicator of financial performance and is obtained by
adding to net profit or loss, finance income and costs,
depreciation and amortization, income taxes, share-based
compensation from stock options, and certain write-downs (or
related reversals) of inventories. “Adjusted EBITDA” excludes the
effects of items that primarily reflect the impact of long-term
investment and financing decisions rather than the results of
day-to-day operations. The Company believes that this measure can
be a useful indicator of its operational performance from one
period to another. The Company uses this non-IFRS measure to make
financial, strategic and operating decisions. Adjusted EBITDA is
not a standardized financial measure under the financial reporting
framework used to prepare the financial statements of the
Corporation to which the measure relates and might not be
comparable to similar financial measures disclosed by other
issuers. A quantitative reconciliation of the Adjusted EBITDA is
presented in the table below:
Reconciliation of Adjusted
EBITDA(In thousands of dollars)
|
Three-month periods ended August 31 |
|
Nine-month periods ended August 31 |
|
|
2024 |
2023 |
|
2024 |
|
2023 |
|
Net income (loss) |
3,091 |
(746 |
) |
(403 |
) |
(21,202 |
) |
Add : |
|
|
|
|
|
|
|
Depreciation and amortization2 |
489 |
868 |
|
2,268 |
|
2,739 |
|
Net Finance costs3 |
2,366 |
674 |
|
6,674 |
|
7,557 |
|
Income tax expense |
756 |
126 |
|
984 |
|
348 |
|
Share-based compensation |
387 |
519 |
|
1,354 |
|
1,797 |
|
Inventory provision4 |
- |
- |
|
1,088 |
|
170 |
|
Restructuring costs |
150 |
719 |
|
486 |
|
719 |
|
Adjusted EBITDA |
7,239 |
2,160 |
|
12,451 |
|
(7,872 |
) |
Conference Call Details
The call will be held
on Thursday, October 10 at 8:30 a.m. ET and will be hosted by Paul
Lévesque, President and Chief Executive Officer. He will be joined
by other members of the management team, including Philippe Dubuc,
Senior Vice President and Chief Financial Officer, Christian
Marsolais, Ph.D., Senior Vice President and Chief Medical Officer
and John Leasure, Global Commercial Officer who will be available
to answer questions from participants following prepared
remarks.
Participants are
encouraged to join the call at least ten minutes in advance to
secure access. Conference call dial-in and replay information can
be found below.
CONFERENCE CALL INFORMATION |
Conference Call Date |
October 10, 2024 |
Conference Call Time |
8:30 a.m. ET |
Webcast link |
https://edge.media-server.com/mmc/p/vy4y3hwc |
Dial in |
1-888-513-4119 (toll free) or 1-412-902-6615 (international) |
Access Code |
5313857 |
CONFERENCE CALL REPLAY |
Toll Free |
1-877-344-7529 (US) / 1-855-669-9658 (Canada) |
International Toll |
1-412-317-0088 |
Replay Access Code |
2159194 |
Replay End Date |
October 17, 2024 |
To access the replay using an international dial-in number, please
select this
link:https://services.choruscall.com/ccforms/replay.html |
An archived webcast
will also be available on the Company’s Investor Relations website
under ‘Past Events'.
About Theratechnologies
Theratechnologies
(TSX: TH) (NASDAQ: THTX) is a biopharmaceutical company focused on
the development and commercialization of innovative therapies
addressing unmet medical needs. Further information about
Theratechnologies is available on the Company's website
at www.theratech.com, on SEDAR+
at www.sedarplus.ca and on EDGAR at www.sec.gov.
Follow Theratechnologies
on Linkedin and Twitter.
Forward-Looking Information
This press release contains forward-looking
statements and forward-looking information (collectively,
“Forward-Looking Statements”), within the meaning of applicable
securities laws, that are based on our management’s beliefs and
assumptions and on information currently available to our
management. You can identify Forward-Looking Statements by terms
such as "may", "will", "should", "could", “would”, "outlook",
"believe", "plan", "envisage", "anticipate", "expect" and
"estimate", or the negatives of these terms, or variations of them.
The Forward-Looking Statements contained in this press release
include, but are not limited to, statements regarding our revised
2024 fiscal year revenue and Adjusted EBITDA guidance, heightened
sales from EGRIFTA SV® in the first quarter of 2025, our strategy
to achieve our long-term objective of delivering sustained top-line
and bottom-line growth, the supply disruption of EGRIFTA SV®, the
resumption of the manufacturing of a batch of EGRIFTA SV®, the
timelines associated to the filing of a PAS with the FDA, the
review timelines of a PAS by the FDA, the resubmission with the FDA
of the sBLA for the F8 Formulation, the publication of results from
Part 3 of our Phase 1 clinical trial studying sudocetaxel
zendusortide in advanced ovarian cancer and the conclusion of
partnerships to market new products. Although the Forward-Looking
Statements contained in this press release are based upon what the
Company believes are reasonable assumptions in light of the
information currently available, investors are cautioned against
placing undue reliance on these statements since actual results may
vary from the Forward-Looking Statements. Certain assumptions made
in preparing the Forward-Looking Statements include that (i) we
will meet our revised revenue and Adjusted EBITDA guidance; (ii) we
will manage inventory to avoid or limit an EGRIFTA SV® shortage to
patients in early 2025; (iii) sales of EGRIFTA SV® will ramp up in
2025; (iv) we will control expenses as planned and no unforeseen
events will occur which would have the effect of increasing our
expenses in 2024 and beyond; (v) our third-party manufacturer will
complete its remediation measures by mid-October and all results
from various tests required to resume manufacturing will allow such
manufacturer to resume its activities to manufacture a batch of
EGRIFTA SV® in the week of October 21, 2024; (vi) we will obtain
from our manufacturer all of the necessary information to file a
PAS within the timelines set forth herein; (vii) the FDA will have
no comment on our PAS within the prescribed timelines and, if any,
we will be able to answer those within such timelines; (viii) the
batch of EGRIFTA SV® to be manufactured in October 2024 will meet
specifications for market release; (ix) the resubmission with the
FDA of the sBLA for the F8 Formulation will be done within the
announced timelines and the FDA will approve such sBLA; (x) we will
be in compliance with the terms and conditions of the Credit
Agreement; (xi) we will be able to generate positive results from
Part 3 of our Phase 1 clinical trial studying sudocetaxel
zendusortide in advanced ovarian cancer; (xii) we will be able to
enter into partnerships to expand our portfolio of commercial
products; (xiii) no event will occur that would prevent us from
executing the objectives set forth in this press release; and (xiv)
we will continue as a going concern. Forward-Looking Statements
assumptions are subject to a number of risks and uncertainties,
many of which are beyond Theratechnologies’ control that could
cause actual results to differ materially from those that are
disclosed in or implied by such Forward-Looking Statements. These
risks and uncertainties include, but are not limited to, (i) a
shortage of EGRIFTA SV® in mid-January 2025; (ii) decline in sales
of EGRIFTA SV® in 2025; (iii) a delay by our third-party
manufacturer to implement and/or complete its remediation measures
to resume its manufacturing activities, including the manufacture
of a batch of EGRIFTA SV® in October 2024; (iv) the new batch of
EGRIFTA SV® not meeting the specifications for release to the
market; (v) a delay in the filing by the Company of a PAS; (vi) the
receipt by the Company of a “Refuse to File” letter from the FDA
following the filing of its PAS or the issuance of information
requests by the FDA during the review period of the PAS leading to
a delay in releasing the newly manufactured batch of EGRIFTA SV®;
(vii) a delay in submitting the sBLA for the F8 Formulation and/or
the non-approval by the FDA of such sBLA; (viii) the Company’s
failure to meet the covenants, obligations and various undertakings
contained in the Credit Agreement which could lead to interest rate
increase on the loaned amounts and/or the foreclosure by the
secured lender of al of the assets of the Company; (ix) our
inability to find products to add to our portfolio or to enter into
agreements the terms and conditions of which would be satisfactory
to us; and (x) the occurrence of events which would lead us to
spend more cash than anticipated, the effect of which could result
in a lower than announced Adjusted EBITDA. We refer current and
potential investors to the “Risk Factors” section of our Annual
Information Form in the form of a Form 20-F Annual Report
dated February 21, 2024, available on SEDAR+ at www.sedarplus.ca
and on EDGAR at www.sec.gov, under Theratechnologies’ public
filings for additional risks related to the Company. The reader is
cautioned to consider these and other risks and uncertainties
carefully and not to put undue reliance on Forward-Looking
Statements. Forward-Looking Statements reflect current expectations
regarding future events and speak only as of the date of this press
release and represent our expectations as of that date. We
undertake no obligation to update or revise the information
contained in this press release, whether as a result of new
information, future events or circumstances or otherwise, except as
may be required by applicable law.
Contacts:
Investor inquiries:Philippe DubucSenior Vice President and Chief
Financial Officerpdubuc@theratech.com1-438-315-6608
Media inquiries:Julie SchneidermanSenior Director,
Communications & Corporate
Affairscommunications@theratech.com1-514-336-7800
1 This is a non-IFRS
measure that is forward looking. The amount indicated diverges
significantly from amounts achieved historically. See “Non-IFRS and
Non-US GAAP Measure” below for such historical amounts and a
reconciliation thereof to the most directly comparable IFRS
measure.2 Includes depreciation of property and equipment,
amortization of intangible, other assets and right-of-use assets.3
Includes all finance income and finance costs consisting of:
Foreign exchange, interest income, accretion expense and
amortization of deferred financing costs, interest expense, bank
charges, gain or loss on financial instruments carried at fair
value and loss on debt modification and gain on lease termination.
4 Inventory provision pending marketing approval of the F8
Formulation.
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