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 and first nine months of fiscal year 2023, ended August 31,
2023. All figures are in U.S. dollars unless otherwise stated.
“Theratechnologies’
reported quarterly revenue of $21 million, demonstrating a solid
recovery as compared to the prior quarter. While new prescription
growth continues on a strong path, we also crossed major milestones
in the advancement of our pipeline and the lifecycle management of
our commercial products,” said Paul Lévesque, President and Chief
Executive Officer. “We are particularly pleased to report a strong
cash balance and adjusted EBITDA of $2.2 million in the third
quarter, which was promised at the beginning of the year and
delivered ahead of schedule.”
"We continue to
execute on value creation in our pipeline. A PDUFA date for the F8
formulation, the next generation of EGRIFTA SV®, is expected
in the upcoming quarter and will position our commercial franchises
for additional revenue growth potential. As such, we are laser
focused on improvements to the bottom line through the remainder of
2023 and into the new year,” concluded Mr. Lévesque.
Revenue Summary for Third Quarter and
First Nine Months of Fiscal 2023 (in thousands of
U.S. dollars)
|
Three months endedAugust 31 |
%change |
Nine months endedAugust 31 |
%change |
|
2023 |
2022 |
|
2023 |
2022 |
|
EGRIFTA®, EGRIFTA SV® net sales |
13,183 |
12,876 |
2.4% |
36,747 |
35,996 |
2.1% |
Trogarzo® net sales |
7,672 |
7,935 |
(3.3)% |
21,565 |
22,640 |
(4.7)% |
Revenue |
20,855 |
20,811 |
0.2% |
58,312 |
58,636 |
(0.1)% |
RECENT HIGHLIGHTS AND PROGRAM
UPDATES
Filing of sBLA for the F8 Formulation of
Tesamorelin
The Company announced that it had filed a
supplemental biologic license application (“sBLA”) for the F8
formulation of tesamorelin (the “F8 Formulation”) with the United
States Food and Drug Administration (“FDA”) on September 25, 2023.
The Company expects to receive an acknowledgment letter of the sBLA
application within 30 days, along with a Prescription Drug User Fee
Act (“PDUFA”) goal date.
Subject to approval by the FDA, we plan on
commercializing the F8 Formulation under the tradename EGRIFTA
MDVTM.
Sudocetaxel Zendusortide Development
Pathway
On August 31, 2023, Theratechnologies announced
that all five of the U.S.-based clinical sites participating in the
conduct of the Phase 1 clinical trial of the Company’s lead
investigational peptide drug conjugate, sudocetaxel zendusortide,
were activated to screen, enroll and dose advanced ovarian cancer
patients. A sixth site based in Canada is finalizing its start-up
activity.
Amendments to the Loan
Facility
On July 28, 2023, Theratechnologies announced
that the Company had entered into an agreement with certain funds
and accounts for which Marathon Asset Management, L.P. acts as
investment manager (collectively, “Marathon”) to amend some of the
terms and conditions of its credit agreement entered into in July
2022 (the “Loan Facility”) to lower the minimum liquidity the
Company must maintain at any time to US$15 million from US$20
million.
The amendments provide, inter alia, that
the Company must hold this minimum amount of liquidity at all times
up to and including October 31, 2023, and must comply with all of
the other terms and conditions of the Credit Agreement.
On September 25, 2023, we announced that we
entered into an agreement in principle with Marathon to further
amend some of the terms and conditions of the Loan Facility.
Subject to completion of the required legal documentation to the
satisfaction of the Company and Marathon, the proposed amendments
would provide for (i) the removal of the obligation to maintain at
all times liquidity in the amount of US$30,000,000 if the F8
Formulation is not approved by the FDA by March 31, 2024; (ii) a
decrease in the minimum liquidity requirements over time to a
minimum of $15,000,000 from $20,000,000 based on targeted last
twelve months adjusted EBITDA; (iii) moving to an adjusted
EBITDA-based target from a quarterly revenue-based target beginning
with the quarter ending November 30, 2023; and (iv) a deletion from
the Loan Facility of the prohibition for the Company to have a
going concern explanatory paragraph in the annual report of the
independent registered public accounting firm of the Company. In
consideration of the proposed amendments, the Company has agreed to
(i) pay an amount equal to $600,000, or 100 basis points calculated
on the funded debt as of this day ($60,000,000), over the term of
the loan and added to the outstanding loan as payment in kind; and
(ii) reprice the exercise price of the 5,000,000 common share
purchase warrants (the “Marathon Warrants”) held by Marathon to
$2.30. Following the share consolidation completed on July 31,
2023, the exercise of four Marathon Warrants is required to
purchase 1 common share of Theratechnologies, resulting in a
maximum issuance of 1,250,000 common shares.
Share Consolidation
On July 31, 2023, Theratechnologies announced
completion of the consolidation of the issued and outstanding
common shares of the Company’s share capital on the basis of one
(1) post-consolidation share for each four (4) pre-consolidation
shares issued and outstanding (the “Consolidation”). No
shareholder approval was required for the Consolidation to come
into effect. The Company’s common shares began trading on the TSX
and the NASDAQ on a consolidated basis on
July 31, 2023.
Any references to the number of common shares,
public offering warrants, Marathon warrants, share options,
weighted average number of common shares, basic and diluted loss
per share and the exercise prices of the public offering warrants,
Marathon Warrants and share options have been retrospectively
adjusted and restated to reflect the effect of the Consolidation,
on a retrospective basis.
2023 Revised Revenue
Guidance
We are tightening our FY2023 revenue guidance
range to between $82 million and $85 million, or growth of the
commercial portfolio in the range of 3% and 6%, as compared to the
2022 fiscal year results.
Third Quarter
Fiscal 2023 Financial Results
The financial results
presented in this press release are taken from the Company’s
Management's Discussion and Analysis dated September 25, 2023
(“MD&A”) and our unaudited consolidated financial statements as
at August 31, 2023 (“Interim Financial Statements”) which have
been prepared in accordance with International Financial Reporting
Standards (“IFRS”) as issued by the International Accounting
Standards Board (“IASB”). The MD&A and the unaudited
consolidated financial statements can be found
at www.sedarplus.ca, on EDGAR at www.sec.gov and
at www.theratech.com. Unless specified otherwise in this press
release, all capitalized terms have the meaning ascribed thereto in
our MD&A.
Revenue
For the three- and
nine-month periods ended August 31, 2023, consolidated revenue was
$20,855,000 and $58,312,000, compared to $20,811,000 and
$58,636,000 for the same periods ended August 31, 2022,
representing a year-over-year increase of 0.2% for the third
quarter and a decrease of 0.1% for the first nine months of the
fiscal year.
For the third quarter
of fiscal 2023, net sales of EGRIFTA SV® were $13,183,000 compared
to $12,876,000 in the third quarter of fiscal 2022, representing an
increase of 2.4% year-over-year. Higher sales of EGRIFTA SV® in the
quarter were mostly the result of a higher selling price but were
hampered by slightly higher rebates to government payers. Net sales
for the nine-month period ended August 31, 2023, which amounted to
$36,747,000 compared to $35,966,000 in the same period in 2022,
representing growth of 2.1%, were mostly affected by the higher
inventory drawdowns at the specialty pharmacy level in the second
quarter of 2023, as explained in our second quarter financial
disclosure.
Trogarzo® net sales in
the third quarter of fiscal 2023 amounted to $7,672,000 compared to
$7,935,000 for the same quarter of 2022, representing a decrease of
3.3% year-over-year. Lower sales of Trogarzo® were a result of our
decision to stop commercializing the product in the European
territory, where we recorded sales of $517,000 in the third quarter
of 2022, as well as slightly lower unit sales in North America,
which were offset by a higher selling price.
For the nine-month
period ended August 31, 2023, Trogarzo® net sales were $21,565,000
compared to $22,640,000 in the same period in 2022. North American
net sales of Trogarzo® were essentially flat when excluding
European net sales of $1,028,000 for the nine-month period ended
August 31, 2022.
Cost of Sales
For the three- and
nine-month periods ended August 31, 2023, cost of sales decreased
to $4,967,000 and $14,569,000 compared to $5,292,000 and
$20,370,000 for the same periods in fiscal 2022.
Cost of goods sold was
$4,967,000 and $14,569 ,000 in the three- and nine-month periods of
2023 compared to $5,292,000 and $17,929,000 for the same periods in
2022. The decrease in cost of goods sold was mainly due to a
higher proportion of EGRIFTA SV® sales, which carry a lower cost of
goods sold than Trogarzo®. For the first nine months of 2023, lower
cost of goods sold is mainly the result of a charge of $1,788,000,
in 2022, arising from the non-production of scheduled batches of
EGRIFTA SV® that were cancelled due to the planned transition to
the F8 Formulation. No such charge was recorded in 2023. The higher
proportion of net sales of EGRIFTA SV® also had a positive impact
on cost of goods sold in 2023, compared to 2022.
Cost of sales also
included the amortization of the other asset of $2,441,000 for the
nine-month period ended August 31, 2022. As the other asset was
fully amortized during fiscal 2022, amortization of the other asset
in fiscal 2023 is nil.
R&D Expenses
R&D expenses in
the three- and nine-month periods ended August 31, 2023, amounted
to $5,396,000 and $25,141,000 compared to $8,425,000 and
$27,484,000 in the comparable periods of fiscal 2022.
R&D expenses
decreased by 36.0% in the third quarter of 2023 compared to the
same period last year, mostly due to the lower spending on our
oncology program, lower spending in Europe, as well as lower
spending following the near-completion of our lifecycle management
projects for EGRIFTA SV® and Trogarzo®. For the first nine months
of 2023, R&D spending decreased by 8.5%, again mostly due to
lower spending on our various programs. R&D expenses in the
first and second quarters of 2023 were also negatively impacted by
expenses of $3,749,000 related to sudocetaxel zendusortide material
and expenses of $536,000 related to the production of
bacteriostatic water for injection (“BWFI”). Excluding these
expenses, R&D expenses are down significantly in the three- and
nine-month periods of 2023 compared to last year, mostly as a
result of lower spending on our oncology program. R&D expenses
also include $508,000 in severance and other expenses related to
the reorganization announced in July 2023.
Selling Expenses
Selling expenses
decreased to $6,728,000 and $20,021,000 for the three- and
nine-month periods ended August 31, 2023, compared to $8,404,000
and $31,582,000 for the same periods last year. The decrease
in selling expenses in the third quarter ended August 31, 2023 is
mainly related to higher expenses incurred in the same period of
2022 related to the setting up of our internal field force in the
United States as well as severance costs incurred following our
decision in 2022 to exit the European market for the
commercialization of Trogarzo®. The decrease in the nine-month
period ended August 31, 2023 is due in large part to a charge of
$6,356,000 related to the accelerated amortization, in Q2 2022 of
the Trogarzo® commercialization rights for the European territory
following our decision to cease commercialization activities in
that territory during that quarter, which also led to decreased
overall spending in commercialization activities. In 2022, we also
incurred one-time costs related to setting up our internal field
force in the United States. Selling expenses also include $141,000
in severance and other expenses related to the reorganization
announced in July 2023.
The amortization of
the intangible asset value for the EGRIFTA SV® and Trogarzo®
commercialization rights is also included under selling expenses.
As such, we recorded amortization expenses of $675,000 and
$2,153,000 for the three- and nine-month periods ended August 31,
2023, compared to $642,000 and $8,539,000, respectively, in
2022.
General and Administrative
Expenses
General and
administrative expenses in the three- and nine-month periods ended
August 31, 2023, amounted to $3,710,000 and $11,878,000,
respectively, compared to $4,209,000 and $13,400,000 reported in
the comparable periods of fiscal 2022. The decrease in general and
administrative expenses is largely due to our decision to terminate
the commercialization activities of Trogarzo® in Europe during the
second quarter of 2022. General and administrative expenses
also include $70,000 in severance and other expenses related to the
reorganization announced in July 2023.
Net Finance Costs
Net finance costs for
the three- and nine-month periods ended August 31, 2023, were
$674,000 and $7,557,000, respectively, compared to $1,879,000 and
$4,808,000 for the comparable periods of 2022. Net finance costs in
the third quarter of 2023 included interest of $2,244,000,
consisting of interest on the convertible senior notes issued in
June 2018 of $128,000, and interest of $2,116,000 on the Loan
Facility. Net finance costs in the nine-month period ended August
31, 2023 included interest of $5,802,000, consisting of interest on
the convertible senior notes issued in June 2018 of $916,000 and
interest on the Loan Facility of $4,986,000. Net finance costs were
also impacted in the nine-month period ended August 31, 2023, by
the loss on debt modification of $2,650,000 related to the issuance
of the 5,000,000 common share purchase warrants (the “Marathon
Warrants”) issued in connection to the amendments to the Loan
Facility during the first quarter of 2023. This was offset by a net
gain on financial instruments carried at fair value of $1,939,000
in the three-month period ended August 31, 2023, and of $2,054,000
in the nine-month period ended August 31, 2023.
Net finance costs for
the three- and nine-month periods ended August 31, 2023, also
included accretion expense of $500,000 and $1,642,000,
respectively, compared to $515,000 and $1,576,000 for the
comparable periods in 2022.
Adjusted EBITDA
Adjusted EBITDA was $2,160,000 for the third
quarter of fiscal 2023 and $(7,872,000) for the nine-month period
ended August 31, 2023, compared to $(3,851,000) and $(19,649,000)
for the same periods of 2022. Adjusted EBITDA in the first and
second quarters of 2023 was negatively affected by expenses of
$3,749,000 related to sudocetaxel zendusortide material and
expenses of $536,000 related to the production of BWFI. No such
expenses were recorded in the third quarter of 2023. See “Non-IFRS
and Non-US-GAAP Measure” and “Reconciliation of Adjusted EBITDA”
below for a reconciliation to Net Loss for the relevant
periods.
Net Loss
Net loss for the
three- and nine-month periods ended August 31, 2023, amounted to
$746,000 and $21,202,000, respectively, compared to $7,549,000 and
$39,308,000, for the same periods in 2022.
Financial Position, Liquidity
and Capital Resources
Going Concern Uncertainty
As part of the
preparation of our Interim Financial Statements, management is
responsible for identifying any event or situation that may cast
doubt on the Company’s ability to continue as a going concern.
Substantial doubt regarding the Company’s ability to continue as a
going concern exists if events or conditions, considered
collectively, indicate that the Company may be unable to honor its
obligations as they fall due during a period of at least, but not
limited to, 12 months from August 31, 2023. If the Company
concludes that events or conditions cast substantial doubt on its
ability to continue as a going concern, it must assess whether the
plans developed to mitigate these events or conditions will remove
any possible substantial doubt.
For the nine-month
period ended August 31, 2023, the Company incurred a net loss of
$21,202,000 (2022 – $39,308,000) and had negative operating cash
flows of $1,572,000 (2022 - $9,491,000). On July 3, 2023, the
Company defaulted under the minimum liquidity covenant (the
“Liquidity Breach”) of the Loan Facility (as defined in Note 7 to
the Interim Financial Statements) resulting in the lender having
the ability to demand immediate repayment of the debt and in making
available to the lender the collateralized assets, which include
substantially all cash, bonds and money market funds which are
subject to control agreements. Accordingly, the Loan Facility has
been classified as a current liability and, as a result, the
Company’s total current liabilities exceeded total current assets
at August 31, 2023. On September 21, 2023, the Company obtained a
waiver from the lender relating to the Liquidity Breach. Refer to
Subsequent events in Note 15 of the Interim Financial
Statements.
The Company’s Loan
Facility is available in four tranches and 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
Notes 18 and 24 of the annual consolidated financial statements as
at November 30, 2022). A Liquidity Breach also entitles the lender
to halt the advance of additional tranches and may trigger an
increase of 300 basis points of the interest rate on the
outstanding loan balance. In July 2023, the Company and the lender
amended the terms of the Loan Facility to reduce the minimum
liquidity covenant for the period of July 10 to July 28, 2023, and
entered into an additional amendment to the terms of the Loan
Facility to provide for the minimum liquidity covenant to be
$15,000,000 from July 29, 2023, to October 31, 2023. After such
date, the minimum liquidity covenant will revert to $20,000,000;
provided, however, that if the F8 Formulation is not approved by
the FDA by March 31, 2024, the minimum liquidity covenant will be
set at $30,000,000. The Loan Facility also includes operational
milestones and required revenue targets (which were amended during
the second quarter, refer to Note 7 of the Interim Financial
Statements) in order for the Company to comply with the conditions
of the Loan Facility and to borrow money forming part of the
various tranches. Furthermore, the Loan Facility includes a
covenant prohibiting having a going concern explanatory paragraph
in the annual report of the independent registered public
accounting firm but the lender amended the Loan Facility on
February 27, 2023 to exclude the fiscal year ended November 30,
2022 from this prohibition. Notwithstanding the agreement in
principle reached on September 24, 2023, there is no assurance that
the lender will agree to amend or to waive any future potential
covenant breaches, if any.
The Company’s ability
to continue as a going concern for a period of at least, but not
limited to, 12 months from August 31, 2023, involves significant
judgement and is dependent on its ability to obtain the support of
the lender (including possible waivers and amendments), increase
its revenues and the management of its expenses to generate
sufficient positive operating cash flows and to find alternative
source of funding to respect the various covenants of its Loan
Facility, including obtaining the approval from the FDA for its F8
Formulation on or before March 31, 2024. Management’s plans include
current negotiations with its lender to obtain amendments to its
Loan Facility, exploring additional alternative sources of funding,
including raising additional equity, and to generate positive
operating cash flows. Some elements of these plans are outside of
management’s control and the outcome cannot be predicted at this
time. Should management’s plans not materialize, the Company may be
in default of the Loan Facility, be forced to reduce or delay
expenditures and capital additions and seek additional alternative
financing, or sell or liquidate its assets. As a result, there is
material uncertainty related to events or conditions that cast
substantial doubt about the Company’s ability to continue as a
going concern.
The Interim 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 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 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
We ended the third quarter of fiscal 2023 with
$22,874,000 in cash, bonds and money market funds. Available cash
is invested in highly liquid fixed income instruments including
governmental and municipal bonds, and money market funds. The
Company currently is required to maintain $15,000,000 in cash,
bonds and money market funds up to and including October 31, 2023,
and, thereafter, $20,000,000, to respect its minimum liquidity
covenant.
The Company voluntarily changed its accounting
policy in fiscal 2022 to classify interest paid and received as
part of cash flows from operating activities, which were previously
classified as cash flow from financing activities and interest
received as cash flows from investing activities. The fiscal 2022
amounts presented herein have been recast to reflect the change in
policy.
For the three-month period ended August 31,
2023, cash flows from operating activities were $5,329,000,
compared to ($1,572,000) in the comparable period of fiscal
2022.
In the third quarter of fiscal 2023, changes in
operating assets and liabilities had a positive impact on cash flow
from operations of $5,329,000 (2022-negative impact of $2,757,000).
These changes included positive impacts from a decrease in
inventories ($2,439,000), lower trade and other receivables
($4,445,000), lower prepaid expenses and deposits ($958,000) and
included a negative impact from accounts payable ($2,947,000). The
decrease in inventories was mainly due to a planned reduction of
Trogarzo® inventory levels. Higher provisions also had a positive
impact on cash flow of $1,687,000.
During the third quarter of fiscal 2023, the
Company received net proceeds of $19,700,000 from the draw-down of
the second tranche under the Loan Facility. On June 30, 2023, we
redeemed the remaining $27,452,000 of convertible senior notes. As
at August 31, 2023, no convertible senior notes remained
outstanding. During the third quarter of fiscal 2022, the Company
realized net proceeds from the issuance of a long-term loan of
$37,715,000. Significant uses of cash for financing activities
during fiscal 2022 included the purchase of convertible senior
notes for $28,746,000 (including costs related to the purchase),
and $1,225,000 in deferred financing costs related to the
establishment of the Loan Facility. There were no other significant
financing activities or investing activities in the three and nine
months ended August 31, 2023, and 2022.
Non-IFRS And Non-US 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
Corporation 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, certain restructuring costs 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 Corporation
believes that this measure can be a useful indicator of its
operational performance from one period to another. The Corporation
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. The Corporation has reinstated
its use of Adjusted EBITDA starting this quarter and has included
Adjusted EBITDA for the comparative period. A quantitative
reconciliation of the Adjusted EBITDA is presented in the table
below:
Reconciliation of Adjusted
EBITDA(In thousands of U.S. dollars)
|
Three-month periods endedAugust 31 |
Nine-month periods endedAugust 31 |
|
2023 |
2022 |
2023 |
2022 |
Net loss |
(746 |
) |
(7,549 |
) |
(21,202 |
) |
(39,308 |
) |
Add : |
|
|
|
|
Depreciation and amortization1 |
868 |
|
856 |
|
2,739 |
|
11,531 |
|
Net Finance costs2 |
674 |
|
1,879 |
|
7,557 |
|
4,808 |
|
Income taxes |
126 |
|
151 |
|
348 |
|
300 |
|
Share-based compensation |
519 |
|
812 |
|
1,797 |
|
3,020 |
|
Inventory provision3 |
- |
|
- |
|
170 |
|
- |
|
Restructuring costs4 |
719 |
|
- |
|
719 |
|
- |
|
Adjusted EBITDA |
2,160 |
|
(3,851 |
) |
(7,872 |
) |
(19,649 |
) |
Conference Call Details
The conference call will be held at 8:30 a.m.
(ET) on September 26, 2023 to discuss the results and recent
business updates. The call will be hosted by Mr. Paul Lévesque,
President and Chief Executive Officer. Joining Mr. Lévesque on the
call will be other members of the management team, including Senior
Vice President and Chief Financial Officer, Mr. Philippe Dubuc,
Senior Vice President and Chief Medical Officer, Dr. Christian
Marsolais, and Global Commercial Officer, Mr. John Leasure 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
is below:
CONFERENCE CALL INFORMATION |
Conference Call Date |
|
September 26, 2023 |
Conference Call Time |
|
8:30 a.m. EDT |
Webcast link |
|
https://edge.media-server.com/mmc/p/3ghrwkyd |
Dial in |
|
1-888-317-6003 (toll free) or
1-412-317-6061 (international) |
Access Code |
|
9250897 |
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 2023
revised fiscal year revenue guidance, our expectations regarding
the commercialization of EGRIFTA SV® and Trogarzo®; our ability and
capacity to grow the sales of EGRIFTA SV® and Trogarzo®
successfully in the United States; our ability to generate a
positive adjusted EBITDA on a quarterly basis; the approval of the
F8 Formulation by the FDA; our capacity to enroll patients and
complete our Phase 1 clinical trial studying sudocetaxel
zendusortide; our capacity to meet the undertakings, covenants and
obligations contained in the Loan Facility and to enter into legal
documents acceptable to both the Company and Marathon (as defined
below) in connection with future amendments to the Loan Facility;
our expectations regarding our financial performance, including
revenues, expenses, gross margins, profitability, liquidity,
capital expenditures and income taxes; and our estimates regarding
our capital requirements.
Such statements
reflect our current views with respect to future events and are
subject to certain risks, uncertainties and assumptions which may
cause our actual results, performance or achievements to be
materially different from any future results, performance or
achievements expressed in or implied by the Forward-Looking
Statements. Certain assumptions made in preparing the
Forward-Looking Statements include that: sales of EGRIFTA SV®
and Trogarzo® in the United States will continue increasing over
time; our expenses will remain under control; our commercial
practices in the United States will not be found to be in violation
of applicable laws; the long-term use of EGRIFTA SV® and
Trogarzo® will not change their respective current safety profile;
no recall or market withdrawal of EGRIFTA SV® and Trogarzo®
will occur; no laws, regulation, order, decree or judgment will be
passed or issued by a governmental body negatively affecting the
marketing, promotion or sale of EGRIFTA SV® and Trogarzo® in
the United States; continuous supply of EGRIFTA SV® and
Trogarzo® will be available to meet market demand on a timely
basis; our relations with third-party suppliers of EGRIFTA SV®
and Trogarzo® will be conflict-free; the level of product returns
and the value of chargebacks and rebates will not exceed our
estimates in relation thereto; no biosimilar version of tesamorelin
will be approved by the FDA; no vaccine or cure will be found for
the prevention or eradication of HIV; the F8 Formulation will be
approved by the FDA for commercialization; we will enter into the
legal documentation satisfactory to both the Company and Marathon
in relation to the proposed amendments to the Loan Facility; we
will not default under the terms and conditions of the Loan
Facility; to the extent we default under the terms of the Loan
Facility, we will be successful in negotiating waivers of such
default; the Corporation will continue as a going concern; we will
be able to recruit patients for our Phase 1 clinical trial studying
sudocetaxel zendusortide and we will be able to see signs of
efficacy during such Phase 1 clinical trial without observing
material adverse side effects; the timelines set forth in this
press release will not be materially adversely impacted by
unforeseen events that could arise subsequent to the date of this
press release; our business plan will not be substantially
modified; and no international event, such as a pandemic or
worldwide war, will occur and adversely affect global trade.
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, those related to or arising from:
the Company’s ability and capacity to grow the sales of EGRIFTA SV®
and Trogarzo® successfully in the United States; the Company’s
capacity to meet supply and demand for its products; the market
acceptance of EGRIFTA SV® and Trogarzo® in the United States; the
continuation of the Company’s collaborations and other significant
agreements with its existing commercial partners and third-party
suppliers and its ability to establish and maintain additional
collaboration agreements; the Company’s success in continuing to
seek and maintain reimbursements for EGRIFTA SV® and Trogarzo® by
third-party payors in the United States; the success and pricing of
other competing drugs or therapies that are or may become available
in the marketplace; events that could disrupt the Company’s ability
to successfully meet the timelines set forth herein; the discovery
of a cure for HIV; the Company’s failure to meet the terms and
conditions set forth in the Loan Facility resulting in an event of
default and causing the interest rate on its loan to increase by
300 basis points and giving right to Marathon to call back the loan
and foreclose on the Company’s assets; our ability to successfully
negotiate further waiver or amendments to the Loan Facility;
non-approval by the FDA of the F8 Formulation; difficulties in
recruiting patients for the Phase 1 clinical trial studying
sudocetaxel zendusortide; negative results stemming from such Phase
1 clinical trial resulting in the abandonment of this development
program; the Company’s expectations regarding its financial
performance, including revenues, expenses, gross margins,
profitability, liquidity, capital expenditures and income taxes;
and the Company’s estimates regarding its capital requirements. We
refer current and potential investors to the “Risk Factors” section
of our Annual Information Form dated February 27, 2023, available
on SEDAR at www.sedarplus.ca and on EDGAR at www.sec.gov as an
exhibit to our report on Form 40-F dated February 28, 2023, 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.
Investor inquiries:Philippe DubucSenior Vice
President and Chief Financial
Officercommunications@theratech.com1-514-336-7800
Media inquiries:Julie
SchneidermanSenior Director, Communications & Corporate
Affairscommunications@theratech.com1-514-336-7800
1 Includes depreciation of property
and equipment, amortization of intangible, other assets and
right-of-use assets.2 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.
3 Inventory provision pending marketing approval of the F8
formulation. 4 Restructuring costs include severance and other
expenses associated with termination of employment related to the
reorganization announced in July 2023.
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