Positive Adjusted EBITDA* for Q4 2023 more than doubles from Q3 2023 to $5 million (Net Loss of $2.8 million) leading to a significant turnaround for the full year versus 2022
Record quarterly revenue of $23.5 million and annual revenue of $81.8 million
Updated Phase 1 trial investigating sudocetaxel zendusortide in advanced ovarian cancer reaches key milestone with enrollment of first six patients
Guidance for 2024 set to $87-90 million in annual revenue and a positive Adjusted EBITDA in the range of $13-15 million for the full year 2024
MONTREAL, Feb. 21, 2024 (GLOBE NEWSWIRE) — Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX:TH) (NASDAQ:THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today reported business highlights and financial results for the fourth quarter and full year of fiscal year 2023, ended November 30, 2023. All figures are in U.S. dollars unless otherwise stated.
Fourth-Quarter and Fiscal 2023 Revenue Highlights
(in 000s of US$)
Three-month
periods ended
November 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 Guidance
Based 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
Revenue
Consolidated 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 Sales
For 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 Expenses
R&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 Expenses
Selling 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 Expenses
General 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 EBITDA
Adjusted 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 Loss
Taking 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
Revenue
Consolidated 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 …
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