On July 9, 2025 Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, reported business highlights and financial results for the second quarter 2025, ended May 31, 2025 (Press release, Theratechnologies, JUL 9, 2025, View Source [SID1234654313]). All figures are in U.S. dollars unless otherwise stated.
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"Demand for EGRIFTA SV remains very strong and we are witnessing record high patient enrollments. During the first half of our fiscal year, we achieved close to $37 million in revenue despite an estimated negative impact of $10-$12 million from the EGRIFTA SV shortage in the first quarter, which was subsequently resolved. Unique patients are back to normal levels, and new patient enrollments, another key metric, are at record highs. This, along with Trogarzo net sales which have now stabilized as expected, indicates a return to our growth trajectory for the top and bottom lines in the coming quarters," said Paul Lévesque, President and Chief Executive Officer. "We are on track to bring EGRIFTA WRTM, a new and improved version of this important medication for people with HIV, to the market in the third quarter, capitalizing on the momentum created in the last 12 months."
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1 This is a non-IFRS measure that is forward looking. The amount indicated diverges significantly from amounts achieved historically. See "Non-IFRS and Non-US GAAP Measure" below for such historical amounts and a reconciliation thereof to the most directly comparable IFRS measure.
Fiscal 2025 Revenue and Adjusted EBITDA Guidance
In light of the previously announced agreement to be acquired by an affiliate of Future Pak, the Company is withdrawing its Fiscal 2025 revenue and Adjusted EBITDA guidance and will not be providing updated guidance.
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 interim consolidated financial statements ("Interim Financial Statements") for the three- and six- month periods ended May 31, 2025, 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 Interim Financial Statements can be found on SEDAR+ at www.sedarplus.ca, on EDGAR at www.sec.gov and at www.theratech.com. Unless specified otherwise, all capitalized terms have the meaning ascribed thereto in our MD&A.
Revenue Summary for Second Quarter and First Half Fiscal 2025
(in thousands of dollars)
Three months
ended May 31 %
change Six months
ended May 31 %
change
2025 2024 2025 2024
EGRIFTA SV net sales 11,131 16,200 (31.3%) 25,011 25,786 (3.0%)
Trogarzo net sales 6,598 5,817 13.4% 11,765 12,478 (5.7%)
Revenue 17,729 22,017 (19.5%) 36,776 38,264 (3.9%)
Revenue
For the three- and six-month periods ended May 31, 2025, consolidated revenue was $17,729,000 and $36,776,000, compared to $22,017,000 and $38,264,000 for the same periods ended May 31, 2024, representing year-over-year decreases of 19.5% for the second quarter and 3.9% for the first half of Fiscal 2025 versus Fiscal 2024.
For the second quarter of Fiscal 2025, net sales of EGRIFTA SV were $11,131,000 compared to $16,200,000 in the second quarter of fiscal 2024, representing a decrease of 31.3% year-over-year. Lower sales of EGRIFTA SV were mostly the result of lower unit sales (-24.9%), as a result of the supply disruption announced by the company in late 2024, and higher government chargebacks, rebates and others (-11.4%), mostly related to the Inflation Reduction Act ("IRA"), which includes new rebates enacted in late 2024 related to patients in the Medicare program. The decrease in sales was offset by a higher selling price (+5.0%).
Net sales for the six-month period ended May 31, 2025, amounted to $25,011,000 compared to $25,786,000 in the same period in 2024, representing a decrease of 3.0%. Lower sales of EGRIFTA SV were mostly the result of lower unit sales (-6.2%), as a result of the supply disruption announced by the Company in late 2024, and higher government chargebacks, rebates and others (-2.4%), mostly related to the Inflation Reduction Act ("IRA"), which includes new rebates enacted in late 2024 related to patients in the Medicare program. The decrease in sales was offset by a higher average selling price (+5.6%).
Trogarzo net sales in the second quarter of Fiscal 2025 amounted to $6,598,000 compared to $5,817,000 for the same quarter of 2024, representing an increase of 13.4% year-over-year. Higher sales of Trogarzo in the quarter were mostly due to higher unit sales (+11.0%) and a higher selling price (+3.0%). Government rebates, chargebacks and others were stable in the quarter compared to Fiscal 2024.
For the six-month period ended May 31, 2025, Trogarzo net sales were $11,765,000 compared to $12,478,000 in the same period in 2024, or a decrease of 5.7%. Lower sales of Trogarzo in the period were mostly due to lower unit sales (-4.1%) and higher government rebates, chargebacks (-4.7%), which were offset by a higher average selling price (+3.1%).
Cost of Goods Sold
For the three- and six-months ended May 31, 2025, cost of goods sold was $4,699,000 and $8,182,000 compared to $4,547,000 and $9,831,000 for the same periods in fiscal 2024.
Three months
ended May 31 Six months
ended May 31
2025 2024 2025 2024
($000s) % of
Revenue ($000s) % of
Revenue ($000s) % of
Revenue ($000s) % of
Revenue
EGRIFTA SV 1,290 11.6% 1,549 9.6% 2,098 8.4% 3,436 9.6%
Trogarzo 3,409 51.7% 2,998 51.5% 6,084 51.7% 6,395 51.5%
Total 4,699 26.5% 4,547 20.7% 8,182 22.2% 9,831 20.7%
For the six-month period ended May 31, 2025, EGRIFTA SV cost of goods sold was reduced by the reversal of an inventory provision in the first quarter of 2025 ($713,000), which was recorded in the fourth quarter of 2024, related to the manufacturing of batches of F8 Formulation recorded prior to approval of the F8 Formulation by the FDA. In the six-month period ended May 31, 2024, EGRIFTA SV cost of goods sold was increased by this inventory provision ($1,088,000). For the three- and six-month periods ended May 31, 2025, the percentage of revenue for the cost of goods sold of EGRIFTA SV excluding these provision changes has increased, mainly due to higher raw materials prices. Trogarzo cost of sales is contractually established at 52% of net sales, subject to periodic adjustment for returns or other factors.
R&D Expenses
R&D expenses in the three- and six-month periods ended May 31, 2025, amounted to $2,614,000 and $5,583,000 compared to $4,725,000 and $8,477,000 in the comparable periods of fiscal 2024. R&D expenses in the three-month period ended May 31, 2024 include the accelerated depreciation ($766,000) of equipment used as part of the preclinical oncology research activities, following the decision to cease early-stage R&D activities.
For the three- and six-month periods ended May 31, 2025, the decrease in R&D expenses is mainly explained by the reduction of spending in our oncology program, as well as lower spending on the F8 Formulation, which was approved in March 2025.
R&D expenses
(in thousands of dollars)
Three months
ended May 31 Six months
ended May 31
2025 2024 %
change 2025 2024 %
change
Oncology
Laboratory research
and personnel 31 1,033* -97% 63 1,366* -95%
Pharmaceutical
product development 13 44 -70% 61 157 -61%
Phase 1 clinical trial 68 588 -88% 153 977 -84%
Medical projects and education 242 278 -13% 448 504 -11%
Salaries, benefits and expenses 1,284 1,271 1% 2,726 2,614 4%
Regulatory activities 417 376 11% 874 807 8%
Trogarzo IM formulation - 6 -100% - 26 -100%
Tesamorelin formulation development 260 448 -42% 832 1,052 -21%
F8 human factor studies 5 5 -% (5) 7 -171%
European activities 46 50 -8% 57 52 10%
Travel, consultants, patents, options, others 343 308 11% 663 579 15%
Restructuring costs - 318 -100% - 336 -100%
Tax Credits (95) (33) 187% (289) (65) 344%
Total 2,614 4,725 -45% 5,583 8,477 -34%
* Including accelerated depreciation ($766,000) of equipment used in the oncology program, following the decision to cease R&D activities related to the oncology program
Selling Expenses
Selling expenses increased to $6,840,000 and $13,310,000 for the three- and six-month periods ended May 31, 2025, compared to $6,367,000 and $12,068,000 for the same periods last year. The increase in selling expenses Fiscal 2025, is due in large part to higher compensation expense, due to lower vacancies and hiring related to market preparation for the Ionis in-licensed products.
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 $361,000 and $722,000 for the three- and six-month periods ended May 31, 2025 compared to $360,000 and $720,000 in the same periods of Fiscal 2024.
General and Administrative Expenses
General and administrative expenses in the three- and six-month periods ended May 31, 2025, amounted to $5,480,000 and $9,710,000 compared to $3,090,000 and $6,846,000 reported in the comparable periods of fiscal 2024. The increase in General and Administrative expenses in the second quarter of 2025 is largely due to professional fees ($1,359,000) incurred with respect to the sale process announced by the Company on April 15, 2025. The increases for the three- and six- month periods ended May 31, 2025 are also due to higher professional fees and higher stock-based compensation.
Adjusted EBITDA
Adjusted EBITDA was $906,000 for the second quarter of fiscal 2025 and $3,227,000 for the six-month period ended May 31, 2025, compared to $5,459,000 and $5,212,000 for the same periods of Fiscal 2024. The decrease is mainly explained by higher spending detailed above, and lower revenues attributable to the supply shortage of EGRIFTA SV which occurred in the first quarter of Fiscal 2025. See "Non-IFRS and Non-US-GAAP Measure" below and "Reconciliation of Adjusted EBITDA" below for a reconciliation to Net Loss for the relevant periods.
Net Finance Costs
Net finance costs for the three- and six-month periods ended May 31, 2025, were $2,312,000 and $3,783,000 compared to $2,183,000 and $4,308,000 for the comparable periods of Fiscal 2024. Net finance costs in the second quarter of Fiscal 2025 included interest of $995,000, versus $2,313,000 in the second quarter of Fiscal 2024 and a $1,074,000 loss on financial instruments carried at fair value. Net finance costs in the six-month period ended May 31, 2025 included interest of $2,001,000 versus $4,587,000 in the six-month period of Fiscal 2024 and a $1,524,000 loss on financial instruments carried at fair value. The decrease in interest expense is the result of the lower interest rates and lower long-term debt outstanding on the Company’s new credit facilities.
For the three-month and six-month periods ended May 31, 2025, the decrease in interest expense was offset by lower interest income as a result of our overall lower cash balances and by a loss on financial instruments carried at fair value.
Net finance costs for the three- and six-month periods ended May 31, 2025, also included accretion expense of $112,000 and $231,000, compared to $382,000 and $756,000 for the comparable periods in 2024.
Income Tax Expense
Income tax expense amounted to $246,000 and $553,000 in the three- and six-month periods ended May 31, 2025, versus $118,000 and $228,000 in the same periods last year. The increase in the three- and six month periods ended May 31, 2025 over the same periods of 2024 is attributable to the higher net fiscal income generated by our operations. The Company recorded $95,000 in Canadian federal non-refundable tax credits in the three-month period ended May 31, 2025 against research and development expenses, and $289,000 in the six-month period ended May 31, 2025, which largely offsets the Canadian federal income tax payable.
Net Loss (Profit)
Net loss for the second quarter ended May 31, 2025, amounted to $4,462,000 compared to a net profit of $987,000 in Fiscal 2024. For the six-month periods ended May 31, 2025 and 2024 the Company recorded net losses of $4,345,000 and $3,494,000, respectively.
Financial Position, Liquidity and Capital Resources
Liquidity and future operations
As part of the preparation of the 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.
As of the issuance date of the Interim Financial Statements, the Company expects that its existing cash and cash equivalents as of May 31, 2025, together with cash generated from its existing operations will be sufficient to fund its operating expenses and debt obligations requirements for at least the next 12 months from the issuance date of these interim financial statements. Considering the recent actions of the Company, material uncertainty that raised substantial doubt about the Company’s ability to continue as a going concern was alleviated effective from the first quarter interim financial statements.
For the six-month period ended May 31, 2025, the Company generated a net loss of $4,345,000 (2024- $3,494,000) and had positive cash flows from operating activities of $2,659,000 (2024- $(1,998,000)). As at May 31, 2025, cash amounted to $9,459,000 and the accumulated deficit was $421,196,000. 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 US Food and Drug Administration. 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 on December 18, 2024. On April 7, 2025, the FDA approved the PAS, allowing the Company to continue releasing EGRIFTA SV to the market without further authorization from the FDA.
The Company’s ability to continue as a going concern for a period of at least, but not limited to, 12 months from May 31, 2025 involves significant judgement and is dependent on continued generation of revenues including a successful transition from EGRIFTA SV to EGRIFTA WR in order to be able to meet the Adjusted EBITDA covenants.
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.
Analysis of cash flows
We ended the second quarter of Fiscal 2025 with $10,139,000 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.
For the three-month period ended May 31, 2025, cash used by operating activities before changes in operating assets and liabilities was $1,679,000, compared to cash generated of $2,616,000 in the comparable period of Fiscal 2024.
In the second quarter of Fiscal 2025, changes in operating assets and liabilities had a positive impact on cash flow of $14,082,000 (2024-negative impact of $2,906,000). These changes included positive impacts from a decrease in accounts receivable ($10,989,000), an increase in accounts payable ($2,700,000), and higher provisions ($1,013,000). Higher inventories had a negative impact on cash flow of $755,000.
During the second quarter of Fiscal 2025, cash used by financing activities totalled $6,885,000 in cash, mostly related to the reimbursement of capital on the TD Bank Credit Facility ($6,786,000), which includes $5,000,000 drawn on the Revolving Credit Facility during the first quarter of 2025.