Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX:
TH) (NASDAQ: THTX), a specialty biopharmaceutical company focused
on the commercialization of innovative therapies that have the
potential to redefine standards of care, today reported business
highlights and financial results for the fourth quarter and full
year of fiscal year 2024, ended November 30, 2024. All figures are
in U.S. dollars unless otherwise stated.
Fourth-Quarter and Fiscal 2024 Revenue
Highlights
(in 000s of
US$) |
|
|
|
|
|
Three-month periods ended November 30, |
% change |
Years ended November 30, |
% change |
|
2024 |
2023 |
|
2024 |
2023 |
|
EGRIFTA SV® net sales |
17,674 |
16,958 |
4.2% |
60,147 |
53,705 |
12.0% |
Trogarzo® net sales |
7,328 |
6,494 |
12.8% |
25,719 |
28,059 |
(8.3%) |
Revenue |
$25,002 |
$23,452 |
6.6% |
$85,866 |
$81,764 |
5.0% |
|
|
|
|
|
|
|
*This is a non-IFRS measure. See “non-IFRS and
non-U.S. GAAP measure” below.
“Fourth quarter of 2024 marked a standout finish
to the year, generating $25 million in revenue and leading to
annual revenue of $85.9 million,” said Paul Lévesque, President and
Chief Executive Officer. “Our bottom line was even stronger,
delivering a positive Adjusted EBITDA for the quarter of $7.8
million, up 56% over fourth quarter of 2023 and a full year result
surpassing $20 million in Adjusted EBITDA, as compared to negative
$3 million in 2023. Our financial success was rewarded by $75
million in new credit facilities with TD Bank and Investissement
Québec, highlighting confidence in our longer-term growth strategy,
which is to strengthen and scale our commercial business
underpinned by our HIV portfolio. We witnessed unprecedented demand
for EGRIFTA SV® this past year resulting in full-year sales of
$60.1 million dollars, which represents 12% growth year-over-year.
We will continue to manufacture additional batches of EGRIFTA SV®
until the anticipated transition to the F8 formulation.
Lévesque added, “The addition of olezarsen and
donidalorsen in Canada are expected to drive long-term growth over
and above our foundational HIV business. I am equally confident
that our team’s demonstrated experience and expertise in
commercializing treatments in the US and Canada will enable us to
deliver on additional assets with new and existing partners. In
parallel, we are actively searching for a partner for our oncology
program to continue the important evaluation of our novel PDCs.
With an FDA protocol amendment in hand to pursue the Phase 1 trial
at higher doses and a comprehensive preclinical and clinical data
set, we believe we can find the right partner to continue this
important science.”
Recent Company Highlights
Remediation to Temporary Supply
Disruption for EGRIFTA SV®
On January 9, 2025, the Company announced a
temporary supply disruption for EGRIFTA SV® caused by an
unexpected voluntary shutdown of the Company’s contract
manufacturer’s facility in 2024, following an inspection by the
United States Food and Drug Administration (“FDA”). The
manufacturer has resumed manufacturing of EGRIFTA SV® in November
2024. In order to resume distribution of EGRIFTA SV®, the
Company was required to file a Prior Approval Supplement (“PAS”)
with the FDA describing the changes made by its manufacturer. The
Company filed the PAS, which is subject to a four month review
period, on December 18, 2024.
On February 13, 2025, the FDA, via its Drug
Shortage Staff, indicated that it would allow the Company to sell
and distribute newly manufactured batches of EGRIFTA SV® while the
review of the PAS is ongoing, thereby allowing the Company to sell
two manufactured batches of EGRIFTA SV®, representing up to six
months of supply. Distribution of the product resumed on February
13, 2025.
In its communication of February 13, 2025, the
FDA indicated that if the Company plans to submit a new or updated
proposal to continue mitigating this shortage beyond these two
batches, the Company should submit the shortage mitigation proposal
to the Drug Shortage Staff so that the FDA can evaluate the
proposal. The Company’s contract manufacturer has already
manufactured one additional batch of EGRIFTA SV®, and two
additional batches are planned before the end of the third quarter
of 2025.
Theratechnologies Receives March 2025
PDUFA Action Date for Updated Tesamorelin F8 Formulation
sBLA
On December 10, 2024, the Company announced that
the FDA has assigned a Prescription Drug User Fee Act (PDUFA)
action date of March 25, 2025 to the Company’s supplemental
Biologics License Application for the F8 formulation of tesamorelin
(“F8 Formulation”), submitted on November 26, 2024. If approved by
the FDA, the F8 Formulation is intended to replace the F4
formulation, which is sold in the U.S. under the trade
name EGRIFTA SV®. The F8 Formulation is patent protected in
the U.S. until 2033.
Company Secures up to $75 Million in New
Credit Facilities with TD Bank and Investissement
Québec
On December 2, 2024, the Company announced that
it had closed on a $40 million three-year non-dilutive, senior
secured syndicated financing with TD Bank, as agent (TD Bank
Financing). This new credit facility includes a $15 million
revolving credit facility, and a term loan totaling $25 million.
The credit facility also includes a $20 million accordion feature,
which could expand total commitments up to $60 million.
Investissement Québec (IQ), the Company’s largest shareholder, has
also agreed to provide a $15 million second ranking secured
subordinated term loan (IQ Subordinated Loan). Net proceeds from
the new loans together with cash on hand were used to repay all
obligations, including prepayment penalties, under the Company’s
existing facility with affiliates of Marathon Asset Management,
L.P. (“Marathon”) pursuant to the credit agreement entered into
with Marathon in July 2022 (the “Marathon Credit Agreement”), and
to fund the $10 million upfront consideration associated to the
Ionis product licenses.
Exclusive Licensing Agreement with Ionis
to Commercialize Olezarsen and Donidalorsen in Canada
On December 4, 2024, the Company announced
it entered into an agreement with Ionis Pharmaceuticals, Inc.
(“Ionis”) to in-license two investigational RNA-targeted medicines
developed by Ionis. Under the agreement, Theratechnologies receives
exclusive rights in Canada for olezarsen, which is being evaluated
for familial chylomicronemia syndrome (FCS) and severe
hypertriglyceridemia (sHTG), and for donidalorsen, which is being
evaluated for the treatment of hereditary angioedema
(HAE).
Sudocetaxel Zendusortide (TH1902) and
SORT1+ Technology™
On December 9, 2024, the Company announced
preliminary efficacy and safety data from Part 3 (dose escalation,
weekly dosing schedule) of its Phase 1b trial of sudocetaxel
zendusortide (TH1902), the Company’s lead investigational peptide
drug conjugate (PDC) in patients with advanced ovarian cancer.
Based on results demonstrating favorable tolerability and signals
of efficacy, the Medical Review Committee, which includes study
investigators and external experts, has unanimously recommended
continued evaluation and exploration of higher doses. On January
31, 2025, the Company received FDA approval to proceed with an
amendment to its Phase 1 study protocol to increase the dose of
sudocetaxel zendusortide on the same weekly infusion cycle to 3.33
followed by 3.90 mg/kg/wk.
The Company is currently reaching out to
pharmaceuticals companies to out-license the rights to sudocetaxel
zendusortide and to its SORT1+ TechnologyTM platform.
Summary of Financial
Results
The financial results presented in this press
release are taken from the Company’s Management's Discussion and
Analysis (“MD&A”), and audited consolidated financial
statements (“Audited Financial Statements”) for the twelve-month
period ended November 30, 2024, or Fiscal 2024, 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 Audited Financial
Statements can be found SEDAR+ at www.sedarplus.ca, on EDGAR at
www.sec.gov and at www.theratech.com. Unless specified otherwise,
all capitalized terms have the meaning ascribed thereto in our
MD&A.
Fourth-Quarter Fiscal 2024 Financial
Results
Revenue
Consolidated revenue for the three months ended
November 30, 2024, amounted to $25,002,000 compared to $23,452,000
for the same period last year, representing an increase of
6.6%.
For the fourth quarter of Fiscal 2024, sales of
EGRIFTA SV® reached $17,674,000 compared to $16,958,000 in the
fourth quarter of the prior year, representing an increase of 4.2%.
Revenue growth for EGRIFTA SV® is mostly related to increased unit
sales (+4.2%) and a higher selling price (+5%), and was hampered by
higher government chargeback and rebates (-1.5%).
In the fourth quarter of Fiscal 2024, Trogarzo®
sales amounted to $7,328,000 compared to $6,494,000 for the same
quarter of Fiscal 2023, representing an increase of 12.8%. The
increase was mainly due to higher unit sales (+11.2%) in the
quarter as compared to last year, as well as a higher selling price
(+3.4%) and was hampered by higher government chargeback and
rebates (-1.8%).
Cost of Sales
In the fourth quarter of Fiscal 2024, cost of
sales was $6,096,000 compared to $5,066,000 for the same period in
Fiscal 2023.
Cost of Sales
|
Three months ended November
30 |
|
2024 |
2023 |
|
($000s) |
% of Revenue |
($000s) |
% of Revenue |
EGRIFTA SV® |
2,289 |
13.0% |
1,713 |
10.1% |
Trogarzo® |
3,807 |
52.0% |
3,353 |
51.6% |
Total |
6,096 |
24.4% |
5,066 |
21.6% |
|
|
|
|
|
For the three-month period ended November 30,
2024, EGRIFTA SV® cost of sales was negatively affected by a
$661,000 inventory provision ($50,000 in the comparable period of
2023) related to the manufacturing of a batch of F8 Formulation, 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 November 30, 2023. 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 fourth quarter of Fiscal
2024 amounted to $5,884,000 compared to $5,229,000 in the
comparable period of Fiscal 2023. R&D expenses were higher
because of the impairment loss on intangible assets related to our
oncology program ($3,488,000). This increase was offset by the
reduction in other R&D expenses in the three-month period ended
November 30, 2024, and were further reduced by the recognition of
Canadian federal non-refundable tax credits ($838,000).
R&D expenses in the fourth quarter of Fiscal
2024 were negatively impacted by an impairment loss of the
intangible asset of $3,488,000 related to the acquisition of our
oncology program. We recorded no such impairment in the three-month
period ended November 30, 2023.
Selling Expenses
Selling expenses in the three-month period ended
November 30, 2024, amounted to $7,044,000 compared to $6,748,000 in
the comparable period of Fiscal 2023, an increase of 4.4%.
The increase in selling expenses is largely
associated with the overall growth of the commercial operations,
in-line with the strategic goal of ensuring continued top-line
revenue growth.
The amortization of the intangible asset value
for the EGRIFTA SV® and Trogarzo® commercialization rights is also
included in selling expenses. As such, we recorded amortization
expense of $360,000 for the three-month period ended November 30,
2024 unchanged as compared to the same period of Fiscal 2023.
General and Administrative
Expenses
General and administrative expenses in the
fourth quarter of Fiscal 2024 amounted to $5,059,000, compared to
$3,739,000 reported in the same period of Fiscal 2023. The increase
in General and administrative expenses is mainly due to higher
stock based compensation expense.
Adjusted EBITDA
Adjusted EBITDA was $7,756,000 for the fourth
quarter of Fiscal 2024, compared to $4,958,000 for the same period
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-month period
ended November 30, 2024, were $7,801,000 compared to $5,352,000 in
the same period of last year. The increase in net finance costs is
due to the higher interest expense on the Marathon Loan Facility,
as well as the higher loss on long-term debt modifications and
repayment related to the repayment of the Marathon Loan
Facility.
Income Tax Expense
Income tax expense amounted to $1,021,000,
versus $73,000 in the same period last year. The increase in the
fourth quarter of 2024 over the same period of 2023 is attributable
to the higher net fiscal income generated by our operations. The
Company recorded Canadian federal non-refundable tax credits in the
three-month period ended November 30, 2024 ($838,000) against
research and development expenses, which largely offsets the
Canadian federal income tax payable. Refer to Note 20 of the
Audited Financial Statements.
Net Loss
Taking into account the revenue and expense
variations described above, the Company recorded a net loss of
$7,903,000, or $0.16 per share, in the fourth quarter of Fiscal
2024 compared to a net loss of $2,755,000, or $0.08 per share, in
the fourth quarter of Fiscal 2023.
Fiscal Year 2024 Financial Results
compared to Fiscal Year 2023 Financial Results
Revenue
Consolidated revenue for Fiscal 2024 was
$85,866,000 compared to $81,764,000 for the same period last year,
representing an increase of 5.0%.
For Fiscal 2024, sales of EGRIFTA SV® reached
$60,147,000 compared to $53,705,000 for the same period last year
representing growth of 12%. The increase in net sales of EGRIFTA
SV® was mostly the result of a higher number of units sold compared
to the previous year (+9.0%), as well as a higher selling price
(+5.6%) and were hampered by higher government chargebacks and
rebates (-2.6%). Overall growth of EGRIFTA SV® unit sales was
hampered in Q1 2024 by draw downs in inventory at specialty
pharmacies, a situation which has now been normalized.
In Fiscal 2024, Trogarzo® net sales were
$25,719,000 compared to $28,059,000 in the prior year, a decrease
of 8.3%. 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. We foresee less of an impact from new
entrants in the future. The decrease is explained by a lower number
of units sold compared to the previous year (-11.4%) and was
mitigated by a higher selling price (+3.7%). The remaining
difference is explained by lower sales in Europe, which were
minimal since we decided to cease selling efforts in Europe in
2022.
Cost of Sales
For Fiscal 2024, cost of sales was $20,448,000
compared to $19,635,000 in Fiscal 2023.
Cost of Sales
|
Fiscal Year ended November
30 |
|
2024 |
2023 |
|
($000s) |
% of Revenue |
($000s) |
% of Revenue |
EGRIFTA SV® |
7,190 |
12.0% |
4,998 |
9.3% |
Trogarzo® |
13,258 |
51.5% |
14,637 |
52.2% |
Total |
20,448 |
23.8 |
19,635 |
24.0% |
|
|
|
|
|
For Fiscal 2024, EGRIFTA SV® cost of sales was
negatively affected by a $1,749,000 inventory provision ($220,000
in Fiscal 2023) related to the manufacturing of a batch of F8
Formulation, as the F8 Formulation has not yet been approved by the
FDA for commercialization. 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 were $16,973,000 for Fiscal
2024 compared to $30,370,000 for Fiscal 2023, a decrease of 44.1%,
mostly due to lower spending on our various programs. R&D
expenses in Fiscal 2024 were also reduced by the recognition of
Canadian federal non-refundable tax credits ($1,488,000).
R&D expenses in the fourth quarter of Fiscal
2024 were negatively impacted by an impairment loss of the
intangible asset of $3,488,000 related to the acquisition of our
oncology program. The Company recorded no such provision in the
three-month period ended November 30, 2024.
R&D expenses in Fiscal 2023 were negatively
impacted by a provision of $3,042,000 related to sudocetaxel
zendusortide material which could expire before Theratechnologies
is able to use it in our clinical program. We recorded no such
provision in Fiscal 2024.
Selling Expenses
Selling expenses for Fiscal 2024 were
$25,419,000 compared to $26,769,000 for Fiscal 2023. The decrease
in selling expenses in Fiscal 2024 is due in large part to tighter
expense control in commercialization activities. Spending in the
third quarter and fourth quarters 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 $1,440,000 for Fiscal 2024 compared to
$2,513,000 in Fiscal 2023.
General and Administrative
Expenses
General and administrative expenses for Fiscal
2024 were $14,852,000 compared to $15,617,000 for Fiscal 2023. The
decrease in general and administrative expenses is largely due to
the implementation of cost-cutting measures announced in Fiscal
2023. General and administrative spending should stabilize in
the future as the cost-cutting measures implemented by the Company
have been completed.
Net Finance Costs
Net finance costs for Fiscal 2024 were
$14,475,000 compared to $12,909,000 in Fiscal 2023. The increase in
net finance costs in Fiscal 2024 versus Fiscal 2023 was mostly due
to the higher interest expense on the Company’s long-term debt
($687,000), as well as higher loss on long-term debt modifications
and repayment related to the amendments to and repayment of the
Marathon Credit Agreement ($2,358,000). These higher costs were
offset by lower accretion and amortization of deferred financing
costs ($1,599,000).
Adjusted EBITDA
Adjusted EBITDA was $20,207,000 for Fiscal 2024
compared to $(2,914,000) for 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.
Income Tax Expense
Income tax expense for Fiscal 2024 amounted to
$2,005,000, versus $421,000 in the same period last year. The
increase in Fiscal 2024 is attributable to the higher net fiscal
income generated by our operations. The Company recorded Canadian
federal non-refundable tax credits ($1,488,000) against research
and development expenses, which largely offsets the Canadian
federal income tax payable. Refer to Note 20 of the Audited
Financial Statements.
Net Loss
Taking into account the revenue and expense
variations described above, we recorded a net loss of $8,306,000,
or $0.17 per share, in Fiscal 2024 compared to $23,957,000, or
$0.91 per share, in Fiscal 2023.
Financial Position, Liquidity and Capital
Resources
Going Concern Uncertainty
As part of the preparation of the 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 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, 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 year ended November 30, 2024, the
Company incurred a net loss of $8,306,000 (2023-$23,957,000;
2022-$47,237,000) and had positive cash flows from operating
activities of $2,379,000 (2023- negative $5,678,000; 2022 negative
$14,692,000). As at November 30, 2024, cash amounted to $5,899,000
and bonds and money market funds amounted to $3,937,000 and the
accumulated deficit is $416,887,000. The Company’s ability to
continue as a going concern requires the Company to continue to
achieve positive cash flows through revenues generation and
managing expenses, and meet the covenants of the TD Credit
Agreement and the IQ Credit Agreement at all times, which require
testing on a quarterly basis.
On January 9, 2025, the Company announced a
temporary supply disruption for EGRIFTA SV® caused by an
unexpected voluntary shutdown of the Company’s contract
manufacturer’s facility in the third quarter of 2024 following an
inspection by the FDA. The manufacturer resumed manufacturing of
EGRIFTA SV®, in November 2024. In order to resume distribution
of EGRIFTA SV®, the Company was required to file a PAS with
the FDA describing the changes made by its manufacturer. The
Company filed the PAS on December 18, 2024. A PAS is usually
reviewed by the FDA within four months of receipt.
On February 13, 2025, the FDA, via its Drug
Shortage Staff, indicated that it would allow the Company to sell
and distribute newly manufactured batches of EGRIFTA SV® even
though the product was manufactured without an approved PAS,
thereby allowing the Company to sell two manufactured batches of
EGRIFTA SV®, representing up to six months of supply. Distribution
of the product resumed on February 13, 2025.
In its communication of February 13, 2025, the
FDA indicated that if the Company plans to submit a new or updated
proposal to continue mitigating this shortage beyond these two
batches, the Company should submit the shortage mitigation proposal
to the Drug Shortage Staff so that the FDA can evaluate the
proposal. The Company’s contract manufacturer has already
manufactured one additional batch of EGRIFTA SV®, and two
additional batches are planned before the end of the third quarter
of 2025.
The Company’s ability to continue generating
revenues through the sale of EGRIFTA SV® and to be able to meet the
Adjusted EBITDA covenants at all times, to be tested on a quarterly
basis, contained in the TD Credit Agreement and the IQ Credit
Agreement for a period of at least, but not limited to, 12 months
from November 30, 2024, involves significant judgement and is
dependent on the full resumption of the distribution of EGRIFTA
SV®, which is dependant on FDA approval.
Should management’s plans not materialize, the
Company may be in default under the TD Credit Agreement and the IQ
Credit Agreement, be forced to reduce or delay expenditures and
capital additions or sell or liquidate its assets. Portions of
management’s plans are outside of their control such as the timing
of full 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 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, 2024, cash, cash
equivalent in escrow, bonds and money market funds amounted to
$19,836,000 compared to $40,387,000 at November 30, 2023.
Available cash is invested in highly liquid fixed income
instruments including governmental, municipal and paragovernmental
organizations, high-grade corporate bonds and money market funds.
On November 30, 2024, $10,000,000 was held in escrow pending
completion of the Ionis Transaction and is therefore presented as
cash equivalent in escrow. See “Subsequent Event”.
The Company voluntarily changed its accounting
policy in Fiscal 2023 to classify interest paid and received as
part of its operating activities, which were previously classified
as cash flow from financing activities and interest received as
cash flows from investing activities.
During Fiscal 2024, cash flows provided by
operating activities were $2,379,000, compared to negative
$5,678,000 in Fiscal 2023.
In Fiscal 2024, changes in operating assets and
liabilities had a negative impact on cash flow from operations of
$5,017,000 (2023-positive impact of $8,133,000). These changes
included negative impacts from higher trade and other receivables
($2,195,000), lower provisions ($1,760,000), lower accounts payable
and accrued liabilities ($1,830,000), and higher prepaid expenses
and deposits ($298,000) while lower tax credits and grants
receivable ($281,000) and lower inventories ($785,000) had a
positive impact on cash flows from operating activities.
During Fiscal 2024, the Company received net
proceeds of $44,576,000 from the issuance of long-term debt and
used $64,908,000 (including prepayment penalties and fees) to fully
reimburse the Marathon Credit Facility.
During Fiscal 2024, investing activities
included the payment of the second tranche of the milestone to
TaiMed Biologics related to the approval of the IV push method of
administration of Trogarzo® ($1,500,000), and was offset by net
proceeds from the sale of bonds and money market funds
($2,383,000).
Outstanding Securities Data
As at February 25, 2025, the number of
issued and outstanding Common Shares amounted to 45,980,019. The
following securities were also issued and outstanding: 5,000,000
Marathon Warrants exercisable into 1,250,000 Common Shares,
5,688,186 share options and 3,381,816 Exchangeable Subscription
Receipts.
Subsequent Events
Licensing agreement
On December 3, 2024, the Company has entered
into an agreement with Ionis Ionis to license two investigational
RNA-targeted medicines developed by Ionis. Under the agreement, the
Company receives exclusive rights in Canada to commercialize
olezarsen, which is being evaluated for familial chylomicronemia
syndrome (FCS) and severe hypertriglyceridemia (sHTG), and
donidalorsen, which is being evaluated for the treatment of
hereditary angioedema (HAE).
The Company paid $10,000,000 on December 5,
2024, upon execution of the agreement, which cash equivalent was
held in escrow at November 30, 2024 from IQ. The Company also
agreed to cash milestone payments based on the achievement of
receipt of regulatory approval milestone and receipt of public
reimbursement approval milestone (up to $5,750,000), annual sales
targets at three different tiers (up to $7,000,000) for
donidalorsen only. In addition, Ionis will also be entitled to
receive tiered double-digit royalties on annual net sales of each
medicine. Royalties on annual net sales of both medicines will be
owed for a period of up to 12 years.
The Company will be responsible for filing,
obtaining and maintaining regulatory approval for olezarsen and
donidalorsen in Canada. Ionis will be manufacturing and supplying
both products to Theratechnologies and has granted the Company a
right to manufacture both products in certain limited
circumstances.
The term of the licensing agreement with Ionis
will continue until the Company permanently ceases commercializing
all licensed products in Canada, or unless earlier terminated in
accordance with customary termination provisions for transactions
of this like-nature.
Tariffs
On February 1, 2025, the President of the United
States signed an executive order which provided that, effective
February 4, 2025, most goods imported into the United States would
be subject to a 25% tariff. The application of the order was
subsequently suspended; however there are discussions about the
re-introduction of those tariffs on goods exported from Canada to
the United States.
EGRIFTA SV® is exported to the United States. It
is too early to determine whether these tariffs will apply to
pharmaceutical products and how they would directly impact the
Company. The Company expects that such tariffs, if effective, will
likely have an adverse effect on its financial results.
Reconciliation of Adjusted
EBITDA
(In thousands of U.S.
dollars)
|
Three-month periods ended November 30 |
Years ended November 30 |
|
2024 |
2023 |
2024 |
2023 |
2022 |
Net loss |
(7,903) |
(2,755) |
(8,306) |
(23,957) |
(47,237) |
Add : |
|
|
|
|
|
Depreciation and amortization1 |
493 |
576 |
2,761 |
3,315 |
12,471 |
Net Finance costs2 |
7,801 |
5,352 |
14,475 |
12,909 |
6,886 |
Income taxes |
1,021 |
73 |
2,005 |
421 |
443 |
Share-based compensation |
2,195 |
418 |
3,549 |
2,215 |
3,872 |
Inventory provision3 |
661 |
50 |
1,749 |
220 |
1,477 |
Restructuring costs4 |
- |
1,244 |
486 |
1,963 |
- |
Impairment loss on intangible assets |
3,488 |
- |
3,488 |
- |
- |
Adjusted EBITDA |
7,756 |
4,958 |
20,207 |
(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, write-offs, gain or
loss on financial instruments carried at fair value and loss on
debt modification and repayment 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, as well as the decision to cease early stage R&D
activities in 2024.
Conference Call Details
The conference call will be held at 8:30 a.m.
(ET) on February 26, 2025, to discuss the results and recent
business updates.
The call will be hosted by Paul Lévesque,
President and Chief Executive Officer, who 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. They 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 26, 2025 |
Conference Call Time |
8:30 a.m. ET |
Webcast link |
https://edge.media-server.com/mmc/p/2h9ningt |
Dial in |
1-877-513-4119 (toll free) or 1-412-902-6615 (international) |
Access Code |
4430181 |
CONFERENCE CALL REPLAY |
Toll Free |
1-877-344-7529 (US) / 1-855-669-9658 (Canada) |
International Toll |
1-412-317-0088 |
Replay Access Code |
3856571 |
Replay End Date |
March 5, 2025 |
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
specialty biopharmaceutical company focused on the
commercialization of innovative therapies that have the potential
to redefine standards of care. 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.
Non-IFRS and Non-US GAAP
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, impairment loss on intangible assets
(new adjustment in fiscal 2024), 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 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 Company 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 above under the table titled
“Reconciliation of Adjusted EBITDA”.
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: (i) our longer-term growth
strategy relying, amongst other things, on the approval by Health
Canada of olezarsen and donidalorsen; (ii) the continuous
manufacture of batches of EGRIFTA SV®; (iii) the approval of the F8
Formulation; and (iv) the search for a partner to pursue the
Company’s Phase 1 clinical trial studying sudocetaxel zendusortide
and/or pursuing the development of the SORT1+ TechnologyTM
platform.
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) sales of EGRIFTA
SV® will not be impacted by the temporary drug shortage which
occurred in the first part of Q1 2025; (ii) our supplier of EGRIFTA
SV® will be able to continue manufacturing this drug and will be
able meet market demands for this product; (iii) the PAS filed by
the Company will be approved by April 18, 2025 in order to allow
the Company to release additional batches of EGRIFTA SV®; (iv) the
Company will be able to obtain from the FDA the release of
additional batches of EGRIFTA SV® if the PAS is not approved by
April 18, 2025; (v) the F8 Formulation will be approved by the FDA
and such approval will be within the timelines announced by the
FDA; (vi) olezarsen and donidalorsen, when filed with Health
Canada, will be approved by this agency for commercialization in
Canada; (vii) olezarsen and donidalorsen will be reimbursed by
public payors; (viii) the Company will be able to find a partner to
pursue the development of sudocetaxel zendusortide and/or its
SORT1+ TechnologyTM platform; (ix) the Company will not be involved
in any material litigation; (x) we will be in compliance with the
covenants, obligations and undertakings contained in the TD Credit
Agreement and the IQ Credit Agreement; (xi) we will tightly control
our expenses; (xii) no event will occur that would require us to
allocate funds to unbudgeted activities; and (xiii) 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 2025; (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)
defaults under the TD Credit Agreement or IQ Credit Agreement
triggering an event of default entitling any of TD or IQ to declare
all amounts owed under their respective credit agreements as
immediately due and payable; (v) non-approval by the FDA of the PAS
and, in such a case, the inability of the Company to obtain an
order from the FDA allowing for the release of additional batches
of EGRIFTA SV® (vi) new drug shortage of EGRIFTA SV® if the Company
is unable to release additional batches of EGRIFTA SV®; (vii)
non-approval of the F8 Formulation; (viii) non-approval of
olezarsen and/or donidalorsen by Health Canada materially adversely
affecting our long-term growth and prospect; (ix) inability of the
Company to find a partner to pursue the development of sudocetaxel
zendusortide and/or its SORT1+ TechnologyTM platform; (x) dispute
or litigation with third parties, including our suppliers; (xi) our
incapacity to identify additional commercial assets or our
inability to enter into commercial agreements regarding same on
terms satisfactory to us; and (xii) 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, 2024 dated February 25, 2025 and to the risk
factors described under Item 3.D of our Form 20-F dated February
26, 2025 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: Investor
inquiries: Joanne Choi Senior Director, Investor Relations
jchoi@theratech.com 1-551-261-0401
Media inquiries: Julie
Schneiderman Senior Director, Communications & Corporate
Affairs communications@theratech.com 1-514-336-7800
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