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 fourth
quarter and full year of fiscal year 2023, ended November 30, 2023.
All figures are in U.S. dollars unless otherwise stated.
Fourth-Quarter and Fiscal 2023 Revenue
Highlights |
(in 000s of US$) |
|
Three-month periods
endedNovember 30, |
% change |
Years ended November 30, |
% change |
|
2023 |
2022 |
|
2023 |
2022 |
|
EGRIFTA SV® net sales |
16,958 |
14,458 |
17.3 |
% |
53,705 |
50,454 |
6.4 |
% |
Trogarzo® net sales |
6,494 |
6,963 |
(6.7 |
%) |
28,059 |
29,603 |
(5.2 |
%) |
Revenue |
$23,452 |
$21,421 |
9.5 |
% |
$81,764 |
$80,057 |
2.1 |
% |
*This is a non-IFRS measure. See “non-IFRS and
non-U.S. GAAP measure” below.
“Fourth quarter of
2023 marked the highest quarterly revenue ever recorded in the
history of Theratechnologies, delivering $23.5 million in revenue
and ending 2023 with total annual revenue of $81.8 million,” said
Paul Lévesque, President and Chief Executive Officer. “This is a
significant accomplishment considering the hurdles we faced in the
first half of 2023 with inventory drawdowns and unfavorable
gross-to-net challenges. Equally, we demonstrated strength on the
bottom line, realizing a positive Adjusted EBITDA for the quarter
of $5 million, more than doubling the third quarter result. We
ended the year with a significant turnaround in Adjusted EBITDA of
only $(2.9) million, an improvement of more than $19 million over
2022. Our efforts to be stringent with operating expenses
while focusing on topline growth have been recognized in the
marketplace, as exemplified by the recent financing that
strengthened our balance sheet with new high-quality institutional
investors such as Investissement Québec.”
Lévesque added,
“EGRIFTA SV® remains the standout product in our portfolio with the
total number of unique patients hitting an all-time high at the end
of calendar 2023, up 13% year over year for the month of December.
Despite facing new market entrants, Trogarzo® remains a good
companion to EGRIFTA SV® and a vital treatment for people with HIV
who have few options. While we were disappointed to receive a
Complete Response Letter from the FDA on January 23, 2024, for our
sBLA for the F8 formulation of tesamorelin, we are confident in
this product and are actively addressing the agency’s concerns so
that we can re-submit the file and continue with our plan to obtain
approval before the end of 2024. To this end, we have been working
closely with external regulatory experts and have requested a Type
A meeting with the FDA.
“By doubling down on
our commercial capabilities, we are determined to create value for
our shareholders and continue generating positive Adjusted EBITDA
in 2024 through organic and inorganic opportunities,” Lévesque
continued. “We are also encouraged by the continued interest in our
oncology program and are pleased to have completed enrollment of
the first six patients in the updated Phase 1 clinical trial
investigating sudocetaxel zendusortide in advanced ovarian cancer.
In parallel, we are advancing preclinical research of new
peptide-drug conjugates with other potent payloads, demonstrating
that our SORT1+ TechnologyTM platform provides strong possibilities
for combining our PDCs with targeted therapies, as well as the
potential for conjugating our peptides with other anticancer
treatment modalities.”
2024 Revenue and Adjusted EBITDA
GuidanceBased on the Company’s performance over the last
six months, Theratechnologies is guiding to $87-90 million in
annual revenue and an Adjusted EBITDA in the range of $13-15
million for the full year 2024.
Fourth-Quarter Fiscal 2023 Financial
Results
RevenueConsolidated revenue for
the three months ended November 30, 2023, amounted to $23,452,000
compared to $21,421,000 for the same period last year, representing
an increase of 9.5%.
For the fourth quarter of Fiscal 2023, sales of
EGRIFTA SV® reached $16,958,000 compared to $14,458,000 in the
fourth quarter of the prior year, representing an increase of
17.3%. Strong sales of EGRIFTA SV® were mostly the result of
increased unit sales, and somewhat offset by higher rebates to
government payers than in Fiscal 2022.
In the fourth quarter of Fiscal 2023, Trogarzo®
sales amounted to $6,494,000 compared to $6,963,000 for the same
quarter of Fiscal 2022, representing a decrease of 6.7%. The
decrease was mainly due to lower unit sales in the quarter as
compared to last year. Lower unit sales in the fourth quarter of
Fiscal 2023, were also a result of higher inventory buildup in
Fiscal 2022, a situation which has resolved itself in Fiscal
2023.
Cost of SalesFor the
three-month period ended November 30, 2023, cost of sales was
$5,066,000 compared to $5,909,000 in the comparable period of
Fiscal 2022. Lower cost of sales for 2023 is explained by a
provision in cost of goods sold for the fourth quarter of Fiscal
2022 which included a provision of $1,477,000 related to the write
down of F8 formulation for pre-commercial material which could
expire prior to the launch of the F8 formulation. This decrease was
partially offset by an increase from higher sales of EGRIFTA SV®
and various production-related costs.
R&D ExpensesR&D
expenses in the three-month period ended November 30, 2023,
amounted to $5,229,000 compared to $9,455,000 in the comparable
period of Fiscal 2022. The decrease during the fourth quarter of
Fiscal 2023 was largely due to lower spending across all areas,
including the Phase 1 clinical trial for sudocetaxel zendusortide,
the human factor study (HFS) for the F8 formulation, as well as the
development of the intramuscular (IM) method of administration of
Trogarzo®. These last two projects were mostly completed in the
fourth quarter of Fiscal 2023. R&D expenses also included
$876,000 in severance and other expenses related to the
reorganization announced in July 2023.
Selling ExpensesSelling
expenses in the three-month period ended November 30, 2023,
amounted to $6,748,000 compared to $7,809,000 in the comparable
period of Fiscal 2022.
The decrease in selling expenses is largely
associated to the careful management of expenses to achieve our
stated goal of achieving a positive Adjusted EBITDA towards the end
of Fiscal 2023. Selling expenses also included $79,000 in severance
and other expenses related to the reorganization announced in July
2023.
General and Administrative
ExpensesGeneral and administrative expenses in the fourth
quarter of Fiscal 2023 amounted to $3,739,000, compared to
$3,956,000 reported in the same period of Fiscal 2022. General and
administrative expenses include $289,000 in severance and other
expenses related to the reorganization announced in July 2023.
Net Finance Costs Net finance
costs for the three-month period ended November 30, 2023, were
$5,352,000 compared to $2,078,000 in the same period last year. The
increase in net finance costs is due to the higher balance
outstanding under the Marathon Credit Agreement, which carries a
higher interest than the Convertible Notes then outstanding in
2022. Net finance costs in the fourth quarter of Fiscal 2022
included interest on the Convertible Notes, whereas this amount was
nil in the fourth quarter of Fiscal 2023. The higher interest is
also a function of higher interest rates in 2023 versus 2022. Other
increases in the fourth quarter of Fiscal 2023 are related to the
costs associated with the amendment to the Loan Facility
($890,000), the write-off of deferred financing costs ($954,000),
and the change in fair value of the Marathon Warrants
($825,000).
Adjusted EBITDAAdjusted EBITDA,
a non-GAAP measure, was $4,965,000 for the fourth quarter of Fiscal
2023, compared to $(2,439,000) for the same period of Fiscal 2022.
See “Non-IFRS and Non-U.S.-GAAP Measure” above and see
“Reconciliation of Adjusted EBITDA” below for a reconciliation to
Net Loss for the relevant periods.
Net LossTaking into account the
revenue and expense variations described above, we recorded a net
loss of $2,755,000, or $0.08 per share, in the fourth quarter of
Fiscal 2023 compared to a net loss of $7,929,000, or $0.09 per
share, in the fourth quarter of Fiscal 2022.
Fiscal Year 2023 Financial Results
compared to Fiscal Year 2022 Financial Results
RevenueConsolidated revenue for
Fiscal 2023 was $81,764,000 compared to $80,057,000 for the same
period last year, representing an increase of 2.1%.
For Fiscal 2023, sales of EGRIFTA SV® reached
$53,705,000 compared to $50,454,000 for the same period last year
representing growth of 6.4%. The increase in net sales of EGRIFTA
SV® was mostly the result of a higher number of units sold compared
to the previous year, as well as a higher net selling price.
Overall growth of EGRIFTA SV® net sales was hampered in 2023 by
draw downs in inventory at one of our large specialty pharmacies
during the second quarter.
In Fiscal 2023,
Trogarzo® net sales were $28,059,000 compared to $29,603,000 in the
prior year, a decrease of 5.2%. Net sales of Trogarzo® were
negatively affected in the second quarter of 2023 by two factors:
(a) drawdowns in inventory at one of our large specialty pharmacies
resulting from larger than necessary purchases in the latter part
of calendar year 2022; and (b) further inventory drawdowns at
another specialty pharmacy with which we renegotiated contract
terms resulting in a lowering of their overall inventory levels.
Net sales of Trogarzo® were also impacted by greater than
anticipated rebates to government payers. The Trogarzo® net sales
decrease is also attributable to a lesser degree to our decision to
stop commercializing the product in Europe in Fiscal 2022,
resulting in a $975,000 decrease in Fiscal 2023.
Cost of SalesFor Fiscal 2023,
cost of sales was $19,635,000 compared to $26,279,000 in the
comparable period of Fiscal 2022. Cost of sales included cost of
goods sold that amounted to $19,635,000 in Fiscal 2023 compared to
$23,838,000 in Fiscal 2022. The decrease in cost of goods sold was
mainly due to a number of factors occurring in Fiscal 2022 that did
not reoccur in Fiscal 2023, namely: (1) a charge arising from the
non-production of scheduled batches of EGRIFTA SV® that were
cancelled due to the planned transition to the F8 formulation in
the amount of $1,788,000; and (2) a provision of $1,477,000 related
to the write down of F8 formulation for pre-commercial material
which could expire prior to the launch of the F8 formulation, if
approved. Cost of goods sold for Fiscal 2023 also included other
provisions totalling $220,000, related to the pending approval of
the F8 formulation (See Note 9 of the Audited Financial
Statements).
In Fiscal 2022, cost of sales included an
amortization charge of $2,441,000 in connection with the settlement
of the future royalty obligation which has been accounted as “Other
asset” on the consolidated statement of the financial position. The
Other asset was fully amortized during the first half of Fiscal
2022, and thus this charge was Nil in Fiscal 2023.
R&D ExpensesR&D
expenses were $30,370,000 for Fiscal 2023 compared to $36,939,000
for Fiscal 2022, a decrease of 17.8%, mostly due to lower spending
on our various programs. R&D expenses in the first and second
quarters of Fiscal 2023 were also negatively impacted by expenses
of $3,730,000 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 Fiscal 2023 compared to last
year, mostly as a result of lower spending on our oncology program.
R&D expenses also included $1,384,000 in severance and other
expenses related to the reorganization announced in July 2023.
Selling ExpensesSelling
expenses for Fiscal 2023 were $26,769,000 compared to $39,391,000
for Fiscal 2022. The decrease in selling expenses is mainly related
to higher expenses incurred in Fiscal 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 is also due in large part to a charge of $6,356,000
related to the accelerated amortization, in the second quarter of
Fiscal 2022, of the Trogarzo® commercialization rights for the
European territory. Selling expenses in Fiscal 2023 included
$220,000 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 $2,513,000 for Fiscal 2023, compared to $9,211,000 in
Fiscal 2022 (which included the charge related to accelerated
amortization of the Trogarzo® commercialization rights for the
European territory).
General and Administrative
ExpensesGeneral and administrative expenses for Fiscal
2023 were $15,617,000 compared to $17,356,000 for the same period
in 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
Fiscal 2022. General and administrative expenses for Fiscal
2023 also included $359,000 in severance and other expenses related
to the reorganization announced in July 2023.
Net Finance Costs Net finance
costs for Fiscal 2023 were $12,909,000 compared to $6,886,000 in
Fiscal 2022. The increase in net finance costs in Fiscal 2023
versus Fiscal 2022 was mostly due to the higher interest expense on
the Company’s Loan Facility ($3,906,000), as well as expenses of
$3,540,000 related to the amendments to the Marathon Credit
Agreement. Other expenses in Fiscal 2023 include the write-off
deferred financing costs ($954,000). These higher costs are offset
by gain on the change of fair value of the Marathon Warrants and a
lower foreign exchange loss.
Adjusted EBITDAAdjusted EBITDA
was $(2,907,000) for Fiscal 2023 compared to $(22,088,000) for
Fiscal 2022. Adjusted EBITDA in the first and second quarters of
Fiscal 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 and fourth quarters of Fiscal 2023. See
“Non-IFRS and Non-U.S.-GAAP Measure” below and see “Reconciliation
of Adjusted EBITDA” below for a reconciliation to Net Loss for the
relevant periods.
Net LossTaking into account the
revenue and expense variations described above, we recorded a net
loss of $23,957,000, or $0.91 per share, in Fiscal 2023 compared to
$47,237,000, or $1.98 per share, in Fiscal 2022.
Financial Position, Liquidity and
Capital Resources
Going Concern Uncertainty
As part of the
preparation of the Audited 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 November 30, 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 year ended November 30, 2023, the
Company incurred a net loss of $23,957,000 (2022-$47,237,000;
2021-$31,725,000) and had negative cash flows from operating
activities of $5,678,000 (2022- $14,692,000; 2021- $17,501,000). As
at November 30, 2023, cash amounted to $34,097,000 and bonds and
money market funds amounted to $6,290,000.
The Marathon Credit Agreement 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 17 of the Audited Financial Statements). A liquidity breach
provides the lender with the ability to demand immediate repayment
of the Loan Facility 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. It
may trigger an increase of 300 basis points of the interest rate on
the outstanding loan balance. On July 3, 2023, the Company incurred
a liquidity breach resulting in the lender having the ability to
demand immediate repayment of the debt, which breach was waived on
September 21, 2023. During Fiscal 2023, the Company entered into
several amendments to the Marathon Credit Agreement to amend
certain of the terms and conditions therein (see note 17 of the
Audited Financial Statements).
The amendments to the Marathon Credit Agreement
covenants resulted in: (i) revising the minimum liquidity
requirements for all times following October 31, 2023 to be between
$15,000,000 and $20,000,000, based on the Marathon Adjusted EBITDA
thresholds over the most recently ended four fiscal quarters; (ii)
revising the minimum revenue requirements to be based on Marathon
Adjusted EBITDA targets instead of quarterly revenue-based targets,
beginning with the quarter ending November 30, 2023; and (iii)
deleting the prohibition against the Company having a going concern
explanatory paragraph in the opinion of the independent registered
public accounting firm of the Company that accompanies the
Company’s annual report. Notwithstanding the latest amendments,
there is no assurance that the lender will agree to amend or to
waive any future potential covenant breaches, if any. The Company
does not meet the condition precedents to drawdown additional
amounts under the Marathon Credit Agreement and does not currently
have other committed sources of financing available to it.
The Company’s ability to continue as a going
concern for a period of at least, but not limited to, 12 months
from November 30, 2023, involves significant judgement and is
dependent on the adherence to the conditions of Marathon Credit
Agreement or to obtain the support of the lender (including
possible waivers and amendments), increase its revenues and the
management of its expenses (including the reorganization mainly
focused on its R&D activities-see Note 16(a) of the Audited
Financial Statements) in order to generate sufficient positive
operating cash flows. Some elements of management’s 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 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. 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 Audited 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 Audited 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 Audited 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
As at November 30, 2023, cash, bonds
and money market funds amounted to $40,387,000 compared to
$33,070,000 at November 30, 2022. Available cash is
invested in highly liquid fixed income instruments including
governmental, municipal and paragovernmental organizations,
high-grade corporate bonds and money market funds. The Company
currently is required to maintain $20,000,000 in cash, bonds and
money market funds to respect its minimum liquidity covenant (the
“Liquidity Covenant”). The Liquidity Covenant can decrease to
$17,500,000 and again to $15,000,000 should the Company achieve the
predetermined Marathon Adjusted EBITDA thresholds (as set forth in
the Marathon Credit Agreement).
The Company voluntarily changed its accounting
policy in Fiscal 2022 to classify interest paid and received as
part of operating activities, which were previously classified as
cash flow from financing activities and interest received as cash
flows from investing activities.
During Fiscal 2023, cash flows used in operating
activities were $5,678,000, compared to $14,692,000 in Fiscal
2022.
In Fiscal 2023, changes in operating assets and
liabilities had a positive impact on cash flow from operations of
$8,133,000 (2022-positive impact of $13,017,000). These changes
included positive impacts from a decrease in inventories
($10,327,000), lower prepaid expenses and deposits ($4,511,000) and
higher provisions ($1,920,000). Decreased accounts payable
($7,508,000) had a negative impact on cash flow, as did higher
trade and other receivables ($902,000). The decrease in inventories
was mainly due to a planned reduction of Trogarzo® inventory
levels.
During the fourth quarter of Fiscal 2023, cash
flows used in operating activities were $5,606,000. Changes in
operating assets and liabilities had a negative impact on cash flow
from operations of $6,910,000. These changes included negative
impacts from an increase in trade and other receivables
($4,339,000) and prepaid expenses and deposits ($1,366,000) as well
as a decrease in accounts payable and accrued liabilities
($2,108,000).
During Fiscal 2023, the Company received net
proceeds of $19,300,000 from the draw-down of the second tranche
under the Marathon Credit Agreement. On June 30, 2023, we redeemed
the remaining $27,452,000 of Convertible Notes. As at November 30,
2023, no Convertible Notes remained outstanding.
During the fourth quarter of Fiscal 2023, the
Company realized net proceeds of $23,575,000 from the issuance of
Common Shares, and Exchangeable Subscription Receipts from the 2023
Public Offering and Concurrent Private Placement. This amount
includes the proceeds from the exercise of the over-allotment
option, resulting in the issuance of 160,000 Common Shares.
The Company does not meet the conditions
precedent to draw-down the third ($15,000,000) and fourth
($25,000,000) tranches of the Loan Facility. These will cease to be
available to the Company after March 31, 2024.
As stated above, the amendments to the Marathon
Credit Agreement covenants resulted in: (i) revising the minimum
liquidity requirements for all times following October 31, 2023 to
be between $15,000,000 and $20,000,000, based on Marathon Adjusted
EBITDA thresholds over the most recently ended four fiscal quarters
(or shorter period set forth in the Marathon Credit Agreement); and
(ii) revising the minimum revenue requirements to be based on
Marathon Adjusted EBITDA targets instead of quarterly revenue-based
targets, beginning with the quarter ending November 30, 2023. While
the Company’s current cash, bonds and money market funds amounted
to $40,387,000, we continue to monitor these balances in order to
continuously meet the minimum liquidity requirements as set out in
the Marathon Credit Agreement. We currently also meet the Marathon
Adjusted EBITDA, and our current operating plan projects that we
will continue to meet these targets for the foreseeable future. We
plan to ensure continued compliance through close management of
expenses and will adapt spending in the event of weakness in our
revenues.
Non-IFRS and Non-U.S. GAAP
MeasureThe 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. A quantitative reconciliation
of “Adjusted EBITDA” is presented under the heading “Reconciliation
of Adjusted EBITDA” below.
The calculation of the “Adjusted EBITDA” in this
press release is different from the calculation of the Adjusted
EBITDA (the “Marathon Adjusted EBITDA”) under the Marathon Credit
Agreement for the purpose of complying with the covenants
therein.
Reconciliation of Adjusted
EBITDA(In thousands of U.S. dollars)
|
Three-month periods ended November 30 |
Years ended November
30 |
|
2023 |
2022 |
2023 |
2022 |
Net loss |
(2,755) |
(7,929) |
(23,957) |
(47,237) |
Add: |
|
|
|
|
Depreciation and amortization1 |
576 |
940 |
3,315 |
12,471 |
Net Finance costs2 |
5,352 |
2,078 |
12,909 |
6,886 |
Income taxes |
73 |
143 |
421 |
443 |
Share-based compensation |
418 |
852 |
2,215 |
3,872 |
Inventory provision (reversal)3 |
50 |
1,477 |
220 |
1,477 |
Restructuring costs4 |
1,244 |
- |
1,963 |
- |
Adjusted EBITDA |
4,958 |
(2,439) |
(2,914) |
(22,088) |
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 and completed in October
2023.
Conference Call Details
The conference call will be held at 8:30 a.m.
(ET) on February 21, 2024, to discuss the results and recent
business updates. The call will be hosted by 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, Philippe Dubuc, Senior
Vice President and Chief Medical Officer, Christian Marsolais,
Ph.D., and Global Commercial Officer, 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 can
be found below.
CONFERENCE CALL INFORMATION |
Conference Call Date |
February 21, 2024 |
Conference Call Time |
8:30 a.m. EDT |
Webcast link |
https://edge.media-server.com/mmc/p/6fyph854 |
Dial in |
1-888-317-6003 (toll free) or 1-412-317-6061 (international) |
Access Code |
0664356 |
CONFERENCE CALL REPLAY |
Toll Free |
1-877-344-7529 (US) / 1-855-669-9658 (Canada) |
International Toll |
1-412-317-0088 |
Replay Access Code |
3842515 |
Replay End Date |
February 28, 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 X (formerly
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 2024
fiscal year revenue and Adjusted EBITDA guidance, our growth
through organic and inorganic opportunities, the resubmission of
the F8 formulation file with the FDA, the conduct of our Phase 1
clinical trial studying sudocetaxel zendusortide and the
development and conjugation of peptide-drug conjugates through
pre-clinical work.
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, including our revenue and Adjusted
EBITDA guidance. Certain assumptions made in preparing the
Forward-Looking Statements include that (i) sales of our products
will continue to grow in 2024; (ii) we will control expenses as
planned and no unforeseen events will occur which would have the
effect of increasing our expenses in 2024; (iii) no biosimilar
version of EGRIFTA SV® will be approved for commercialization in
the United States, (iv) no unapproved products for the treatment of
lipodystrophy will be used as replacement to EGRIFTA SV®; (v)
physicians and patients will continue to accept our drug products
as safe and effective drugs; (vi) our suppliers will be able to
meet market demands for our products; (vii) no dispute or
litigation will occur between the Company and our main suppliers;
(viii) our approved products will continue to be reimbursed at the
Federal and State level in the United States; (ix) we will be able
to adequately address the questions received from the FDA and to
resubmit our F8 formulation file for approval; (x) the FDA will
approve the F8 formulation; (xi) our Phase 1 clinical trial
studying sudocetaxel zendusortide will show signs of efficacy
without impairing its safety profile; (xii) we will be successful
in developing new peptide-drug conjugates and in deriving values
from our SORT1+ TechnologyTM platform; (xiii) we will be successful
in identifying and entering into one or more transactions to add
one or more commercial assets as part of our commercial portfolio
of approved products; (xiv) we will be in compliance with the
covenants, obligations and undertakings contained in the Marathon
Credit Agreement; (xv) we will tightly control our expenses; (xvi)
no event will occur that would require us to allocate funds to
unbudgeted activities; and (xvii) no event will occur preventing us
from executing the objectives set forth in this press release.
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 decrease or stagnation in
sales of our products in 2024; (ii) product recalls or change in
the regulation that would adversely impact the sale of our
products; (iii) unknown safety or efficacy issues with our approved
drug products causing a decrease in demand for those products; (iv)
the occurrence of events which would lead us to spend more cash
than anticipated, the effect of which could result in a negative
Adjusted EBITDA position by the 2024 fiscal year-end; (v) defaults
under the Marathon Credit Agreement triggering an increase of 300
basis points on the outstanding loaned amount and the right of
Marathon to declare all amounts owed under the Marathon Credit
Agreement as immediately due and payable; (vi) dispute or
litigation with our suppliers; (vii) the non-approval by the FDA of
the F8 formulation when resubmitted; (viii) our incapacity to
identify additional commercial assets or our inability to enter
into commercial agreements regarding same on terms satisfactory to
us; and (ix) changes in our business plan.
We refer current and potential investors to the
risk factors described under the section “Risks and Uncertainties”
of our Management’s Discussion and Analysis for the fiscal year
ended November 30, 2023 dated February 20, 2024 and to the risk
factors described under Item 3.D of our Form 20-F 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.com1-514-336-7800
Media inquiries:Julie
SchneidermanSenior Director, Communications & Corporate
Affairscommunications@theratech.com1-514-336-7800
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