Theratechnologies Reports Financial Results for the First Quarter 2025 and Reviews Key Achievements
FDA Approves EGRIFTA WR™ (Tesamorelin F8) to Treat Excess Visceral Abdominal Fat in Adults with HIV and Lipodystrophy
Total Revenue $19 million, representing +17% growth year over year
FDA Approves Prior Approval Supplement (PAS) for EGRIFTA SV® sBLA
Latest from VAMOS study demonstrates excess visceral abdominal fat drives cardiovascular risk
MONTREAL, April 09, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX:TH) (NASDAQ:THTX), a commercial-stage biopharmaceutical company, today 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.
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."
____________________________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
RevenueConsolidated 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 SoldIn 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 monthsended February
Feb. 28, 2025
Feb. 29 2024
($000s)
% ofRevenue
($000s)
% ofRevenue
EGRIFTA SV®
808
5.8
%
1,887
19.7
%
Trogarzo®
2,675
51.8
%
3,397
https://www.benzinga.com/pressreleases/25/04/g44708141/theratechnologies-reports-financial-results-for-the-first-quarter-2025-and-reviews-key-achievement
