On April 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 first quarter 2025, ended February 28, 2025. All figures are in U.S. dollars unless otherwise stated (Press release, Theratechnologies, APR 9, 2025, View Source [SID1234651855]).
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First-Quarter 2025 Revenues
(in thousands of U.S. dollars)
Three Months Ended Change
February 28,
2025 February 29,
2024
EGRIFTA SV net sales 13,880 9,586 44.8 %
Trogarzo net sales 5,167 6,661 (22.4 %)
Revenue 19,047 16,247 17.2 %
"We are extremely pleased to have ended our fiscal first quarter in a strong position with total revenue of $19 million, representing 17% growth year-over-year, a net profit of $117,000, and positive adjusted EBITDA1 of $2.3 million. While this number is mainly related to reloading the pipeline following an end to the temporary supply disruption, the fundamentals of the business and specifically demand for EGRIFTA SV remains very strong," said Paul Lévesque, President and Chief Executive Officer. "Our HIV portfolio led by the EGRIFTA franchise will continue to remain our engine of growth for years with the recent approval of EGRIFTA WR which will drive further adoption and adherence."
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1 This is a non-IFRS measure. See "non-IFRS and non-U.S. GAAP measure" below
Recent Company Highlights
Theratechnologies Receives FDA Approval for EGRIFTA WR (Tesamorelin F8) to Treat Excess Visceral Abdominal Fat in Adults with HIV and Lipodystrophy
On March 25, 2025, the Company announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin for injection. The Company will commercialize the new formulation under the tradename EGRIFTA WR.
Tesamorelin for injection is the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy. The new formulation, EGRIFTA WR, is a daily injectable but only needs weekly reconstitution. It requires less than half the administration volume as the current F4 formulation, sold in the U.S. as EGRIFTA SV, which is reconstituted daily.
EGRIFTA WR will be supplied as four single-patient-use vials, each containing 11.6 mg of tesamorelin, sufficient for seven doses. The daily dose is 1.28 mg (0.16 mL of the reconstituted solution) injected subcutaneously. The product can be stored at room temperature (20° to 25° C [68° to 77° F]) before and after reconstitution.
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 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 PAS with the FDA describing the changes made by its manufacturer. The Company filed the PAS and the PDUFA goal date has been set to April 18, 2025.
Upon resuming distribution of EGRIFTA SV to its distributor on February 14, 2025, the Company received large orders until the end of its first quarter to rebuild inventories at both McKesson and in our specialty pharmacy network, with some pharmacies ordering larger than usual quantities. This will result in a longer drawdown than usual, and should have an impact on Q2 revenues while pharmacy inventories revert to normal levels. Considering that patients were off treatment for 6 to 7 weeks, we estimate that the drug shortage will have a one-time impact of $10 to $12 million on revenues for the 2025 fiscal year.
Approval of Prior Approval Supplement for EGRIFTA SV sBLA by the FDA
On April 7, 2025, the Company announced the FDA approved the Company’s PAS for EGRIFTA SV. Approval of the PAS removes any regulatory requirement for discretionary product release, thereby allowing Theratechnologies to resume regular distribution of EGRIFTA SV.
Theratechnologies CROI Presentation Highlights Limitations of Using BMI to Assess Cardiovascular (CV) Risk in People with HIV
On March 12, 2025, the Company announced that it presented data highlighting the limitations of using body mass index (BMI) alone in assessing cardiovascular (CV) risk in people with HIV (PWH). The study underscores the need to incorporate screening for excess visceral abdominal fat (EVAF) to better identify PWH at risk of CV disease.
Theratechnologies Presents Encouraging Virologic Suppression Data from the PROMISE-US Trial of Ibalizumab at CROI
On March 12, 2025, the Company announced that it presented data from a real-world, observational, registry study demonstrating the efficacy and safety of ibalizumab in reducing HIV RNA to undetectable levels in heavily treatment-experienced (HTE) patients with multidrug resistant HIV.
2025 Revenue and Adjusted EBITDA Guidance
As a result of the supply disruption of EGRIFTA SV during the first quarter of 2025 described above (see "Recent Highlights – Remediation to Temporary Supply Disruption for EGRIFTA SV") resulting in a one-time loss of 6 to 7 weeks of sales ($10 to $12 million), and taking into account the approval of EGRIFTA WR, we estimate FY2025 revenue to be in the range of $80 million to $83 million while we anticipate Adjusted EBITDA, a non-IFRS measure, to be between $10 and $12 million for the same period.
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-month period ended February 28, 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 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.
First Quarter 2025 Financial Results
Revenue
Consolidated revenue for the three months ended February 28, 2025, amounted to $19,047,000 compared to $16,247,000 for the same period last year, representing an increase of 17.2%.
For the first quarter of Fiscal 2025, sales of EGRIFTA SV reached $13,880,000 compared to $9,586,000 in the first quarter of the prior year, representing an increase of 44.8%. Higher sales of EGRIFTA SV were mostly the result of higher unit sales (+24.0%), a higher selling price (+6.7%) and the remainder of the difference is explained by lower government chargebacks, rebates and others. The increase in unit sales of EGRIFTA SV in 2025 were mostly due to the rebuilding of distributor and pharmacy inventories following the supply disruption of EGRIFTA SV in the first quarter of 2025. On February 13, 2025, the FDA authorized the release of two batches of EGRIFTA SV and the Company recorded sales of EGRIFTA SV during the last two weeks of February 2025. In the first quarter of 2024 sales of EGRIFTA SV were negatively affected by inventory drawdowns at the specialty pharmacy level.
In the first quarter of Fiscal 2025, Trogarzo sales amounted to $5,167,000 compared to $6,661,000 for the same quarter of 2024, representing a decrease of 22.4%. Lower sales of Trogarzo were mostly due to lower unit sales (-17.5%), which were offset by a higher selling price (+2.9%). The remainder of the decrease is explained by higher government rebates, chargebacks and others. Trogarzo unit sales in the first quarter of 2025 were down mostly as a result of the entry of new competitors in the market in the past few years.
Cost of Goods Sold
In the first quarter of Fiscal 2025, cost of goods sold was $3,483,000 compared to $5,284,000 for the same period in Fiscal 2024.
Three months
ended February
Feb. 28, 2025 Feb. 29 2024
($000s) % of
Revenue ($000s) % of
Revenue
EGRIFTA SV 808 5.8 % 1,887 19.7 %
Trogarzo 2,675 51.8 % 3,397 51.0 %
Total 3,483 18.3 % 5,284 32.5 %
For the three-month period ended February 28, 2025, EGRIFTA SV cost of goods sold was reduced by the reversal of an inventory provision ($713,000) related to the manufacturing of batches of F8 Formulation recorded prior to approval of the F8 Formulation by the FDA. In the first quarter of 2024, cost of goods sold was increased by this inventory provision ($837,000). The percentage of revenue for EGRIFTA SV excluding these provision changes is comparable for the first quarter of 2025 and 2024. Trogarzo cost of goods sold 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-month period ended February 28, 2025 amounted to $2,969,000 compared to $3,752,000 in the comparable period of Fiscal 2024, a decrease of 21.2%. The decrease during the first quarter of Fiscal 2025 was largely due to lower spending on life-cycle management projects as well as lower activity in our oncology program, as well as the recognition of non-refundable federal tax credits.
R&D expenses
(in thousands of dollars)
Three months
ended
Feb. 28
2025 Feb. 29
2024 %
change
Oncology
Laboratory research
and personnel 32 333 -90%
Pharmaceutical
product development 48 113 -58%
Phase 1 clinical trial 85 389 -78%
Medical projects and education 206 226 -9%
Salaries, benefits and expenses 1,442 1,343 8%
Regulatory activities 457 431 6%
Trogarzo IM formulation - 20 -100%
Tesamorelin formulation development 572 604 -5%
F8 human factor studies (10) 2 -%
European activities 11 2 450%
Travel, consultants, patents, options, others 320 303 2%
Restructuring costs - 18 -100%
Tax credits (194) (32) 506%
Total 2,969 3,752 -21%
Selling Expenses
Selling expenses in the three-month period ended February 28, 2025, amounted to $6,470,000 compared to $5,701,000 in the comparable period of Fiscal 2024 or an increase of 13.5%. Higher selling expenses are mostly due to higher compensation expense versus last year, due to lower vacancies and hiring related to market preparation for the Ionis in-licensed products.
General and Administrative Expenses
General and administrative expenses in the first quarter of Fiscal 2025 amounted to $4,230,000, compared to $3,756,000 reported in the same period of Fiscal 2024, representing an increase of 12.6%. The increase is a result of higher compensation expenses and professional fees.
Net Finance Costs
Net finance costs for the three-month period ended February 28, 2025, were $1,471,000 compared to $2,125,000 in the same period last year. The decrease in net finance cost is mostly due to lower interest expense on long-term debt ($1,268,000) and lower accretion expense, write-off and amortization of deferred financing costs ($255,000). These declines in finance costs were offset by a loss on financial instruments carried at fair value ($450,000) and by lower interest income ($563,000). Interest on long-term debt was $1,006,000 in the first quarter of 2025, compared to $2,274,000 in 2024, reflecting the lower interest rates and lower long-term debt outstanding on the Company’s new credit facilities.
Adjusted EBITDA
Adjusted EBITDA was $2,321,000 for the first quarter of fiscal 2025 compared to $(247,000) for the same period of 2024. The improvement is mainly due to the higher revenue in the first quarter of 2025. See "Non-IFRS and Non-US-GAAP Measure" above and see "Reconciliation of Adjusted EBITDA" below for a reconciliation to Net Profit (loss) for the relevant periods.
Income Tax Expense
Income tax expense amounted to $307,000, versus $110,000 in the same period last year. The increase in the first quarter of 2025 over the same period of 2024 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 February 28, 2025 ($194,000) against research and development expenses, which largely offsets the Canadian federal income tax payable.
Net Profit
Taking into account the revenue and expense variations described above, we recorded a net profit of $117,000, or $0.00 per share, in the first quarter of Fiscal 2025, as compared to a loss of $4,481,000, or a loss of $0.10 per share, recorded in the first quarter of Fiscal 2024.
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 these interim financial statements, the Company expects that its existing cash and cash equivalents as of February 28, 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 these first quarter interim financial statements.
For the three-month period ended February 28, 2025, the Company generated a net profit of $117,000 (2024- net loss of $4,481,000) and had negative cash flows from operating activities of $9,744,000 (2024- $1,708,000). As at February 28, 2025, cash amounted to $3,905,000, working capital (current assets less current liabilities) amounted to $2,668,000 and the accumulated deficit was $416,770,000. 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 PAS with the FDA describing the changes made by its manufacturer. The Company filed the PAS on December 18, 2024.
On February 13, 2025, the FDA, via its Drug Shortage Staff (DSS), 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 patient supply. Distribution of the product has resumed on February 14, 2025. The Company has already manufactured two additional batches, and a new batch is currently scheduled for production in July 2025.
On March 25, 2025, the FDA has approved the Company’s supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin for injection. The Company will commercialize the new formulation under the tradename EGRIFTA WR. The Company plans to launch EGRIFTA WR in the third quarter of 2025.
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 February 28, 2025 involves significant judgement and is dependent on continued generation of revenues including a timely 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 first quarter of fiscal 2025 with $4,548,000 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 February 28, 2025, cash generated by operating activities before changes in operating assets and liabilities improved to $2,457,000, compared to a use of $3,129,000 in the comparable period of Fiscal 2024.
In the first quarter of fiscal 2025, changes in operating assets and liabilities had a negative impact on cash flow of $12,201,000 (2024-positive impact of $1,421,000). These changes included a negative impact from higher accounts receivable ($6,773,000), mostly due to the concentration of EGRIFTA SV sales in the last two weeks of the quarter. Also having a negative impact were lower accounts payable ($3,948,000), higher prepaid expenses and deposits ($804,000) and higher inventories ($1,580,000). These changes were offset by positive impacts from higher provisions ($870,000).
During the first quarter of 2025, cash used by operating activities amounted to $9,744,000, compared to cash provided by operating of $1,708,000 in the first quarter of 2024.
During the first quarter of 2025, cash provided by financing activities was $4,665,000, which included proceeds from the issuance of long-term debt of $5,000,000 from the Revolver, while investing activities used $6,902,000, and included a $10,000,000 upfront payment to Ionis, while the sale of bonds and money market funds generated proceeds of $3,202,000.
Outstanding Securities Data
As at April 8, 2025, the number of common shares issued and outstanding was 45,980,019. We also had 5,000,000 Marathon Warrants issued and outstanding, exercisable into 1,250,000 common shares, 5,643,759 options granted under our stock option plan and 3,381,816 Exchangeable Subscription Receipts.
Reconciliation of Adjusted EBITDA
(In thousands of U.S. dollars)
Three-month periods ended February
28, 2025 29, 2024
Net profit (loss) 229 (4,481 )
Add :
Depreciation and amortization2 491 517
Net Finance costs3 1,471 2,125
Income taxes 307 110
Restructuring costs - 18
Inventory provision4 (713 ) 837
Share-based compensation 536 627
Adjusted EBITDA 2,321 (247 )
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2 Includes depreciation of property and equipment, amortization of intangible, other assets and right-of-use assets.
3 Includes all finance income and finance costs consisting of: Foreign exchange, interest income, accretion expense, write-off and amortization of deferred financing costs, interest expense, gain or loss on financial instruments carried at fair value and loss on debt modifications and repayment and gain on lease termination and other.
4 Inventory provision pending marketing approval of the F8 Formulation in Q1 2024 and reversal of such provision in Q1 2025 following approval of the F8 Formulation on March 25, 2025.
Conference Call Details
The conference call will be held at 8:30 a.m. (ET) on April 9, 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 April 9, 2025
Conference Call Time 8:30 a.m. ET
Webcast link View Source
Dial in 1-877-513-4119 (toll free) or 1-412-902-6615 (international)
Access Code 2419339
CONFERENCE CALL REPLAY
Toll Free 1-877-344-7529 (US) / 1-855-669-9658 (Canada)
International Toll 1-412-317-0088
Replay Access Code 5058651
Replay End Date April 16, 2025
To access the replay using an international dial-in number, please select this link:
View Source
An archived webcast will also be available on the Company’s Investor Relations website under ‘Past Events’.