Theratechnologies Reports Financial Results for the First Quarter 2025 and Reviews Key Achievements
Theratechnologies (NASDAQ: THTX) reported strong Q1 2025 financial results with total revenue of $19 million, representing 17.2% growth year-over-year. The company achieved a net profit of $117,000 and positive adjusted EBITDA of $2.3 million.
Key highlights include:
- FDA approval of EGRIFTA WR™ for treating excess visceral abdominal fat in HIV patients
- EGRIFTA SV® sales increased 44.8% to $13.9 million
- Trogarzo® sales decreased 22.4% to $5.2 million
- Resolution of temporary supply disruption for EGRIFTA SV®
The company updated its FY2025 guidance, projecting revenue between $80-83 million and adjusted EBITDA of $10-12 million, accounting for a one-time impact of $10-12 million revenue loss due to the EGRIFTA SV® supply disruption.
Theratechnologies (NASDAQ: THTX) ha riportato risultati finanziari solidi per il primo trimestre del 2025, con un fatturato totale di 19 milioni di dollari, che rappresenta una crescita del 17,2% rispetto all'anno precedente. L'azienda ha raggiunto un utile netto di 117.000 dollari e un EBITDA rettificato positivo di 2,3 milioni di dollari.
I punti salienti includono:
- Approvazione della FDA per EGRIFTA WR™ per il trattamento dell'eccesso di grasso viscerale addominale nei pazienti con HIV
- Le vendite di EGRIFTA SV® sono aumentate del 44,8% raggiungendo 13,9 milioni di dollari
- Le vendite di Trogarzo® sono diminuite del 22,4% a 5,2 milioni di dollari
- Risoluzione della temporanea interruzione della fornitura di EGRIFTA SV®
L'azienda ha aggiornato le sue previsioni per l'anno fiscale 2025, prevedendo un fatturato compreso tra 80 e 83 milioni di dollari e un EBITDA rettificato di 10-12 milioni di dollari, tenendo conto di un impatto una tantum di perdita di fatturato di 10-12 milioni di dollari a causa dell'interruzione della fornitura di EGRIFTA SV®.
Theratechnologies (NASDAQ: THTX) informó resultados financieros sólidos para el primer trimestre de 2025, con ingresos totales de 19 millones de dólares, lo que representa un crecimiento del 17.2% en comparación con el año anterior. La empresa logró una ganancia neta de 117,000 dólares y un EBITDA ajustado positivo de 2.3 millones de dólares.
Los aspectos destacados incluyen:
- Aprobación de la FDA para EGRIFTA WR™ para tratar el exceso de grasa abdominal visceral en pacientes con VIH
- Las ventas de EGRIFTA SV® aumentaron un 44.8% a 13.9 millones de dólares
- Las ventas de Trogarzo® disminuyeron un 22.4% a 5.2 millones de dólares
- Resolución de la interrupción temporal del suministro de EGRIFTA SV®
La empresa actualizó su guía para el año fiscal 2025, proyectando ingresos entre 80 y 83 millones de dólares y un EBITDA ajustado de 10 a 12 millones de dólares, teniendo en cuenta un impacto único de pérdida de ingresos de 10 a 12 millones de dólares debido a la interrupción del suministro de EGRIFTA SV®.
Theratechnologies (NASDAQ: THTX)는 2025년 1분기 재무 실적을 발표했으며, 총 수익은 1,900만 달러로 전년 대비 17.2% 성장했습니다. 회사는 117,000 달러의 순이익과 230만 달러의 긍정적인 조정 EBITDA를 달성했습니다.
주요 하이라이트는 다음과 같습니다:
- HIV 환자의 복부 내장 지방 과다 치료를 위한 EGRIFTA WR™의 FDA 승인
- EGRIFTA SV®의 매출이 44.8% 증가하여 1,390만 달러에 도달
- Trogarzo®의 매출이 22.4% 감소하여 520만 달러
- EGRIFTA SV®의 일시적 공급 중단 문제 해결
회사는 2025 회계연도 가이드를 업데이트하여 수익을 8천만 달러에서 8,300만 달러로 예상하고 조정 EBITDA는 1천만 달러에서 1,200만 달러로 예상하며, EGRIFTA SV® 공급 중단으로 인한 1회성 수익 손실 1천만 달러에서 1,200만 달러를 반영했습니다.
Theratechnologies (NASDAQ: THTX) a annoncé de solides résultats financiers pour le premier trimestre 2025, avec un chiffre d'affaires total de 19 millions de dollars, représentant une croissance de 17,2 % par rapport à l'année précédente. L'entreprise a réalisé un bénéfice net de 117 000 dollars et un EBITDA ajusté positif de 2,3 millions de dollars.
Les points clés incluent :
- Approbation de la FDA pour EGRIFTA WR™ pour traiter l'excès de graisse abdominale viscérale chez les patients atteints de VIH
- Les ventes d'EGRIFTA SV® ont augmenté de 44,8 % pour atteindre 13,9 millions de dollars
- Les ventes de Trogarzo® ont diminué de 22,4 % pour s'établir à 5,2 millions de dollars
- Résolution de la perturbation temporaire de l'approvisionnement d'EGRIFTA SV®
L'entreprise a mis à jour ses prévisions pour l'exercice 2025, projetant un chiffre d'affaires compris entre 80 et 83 millions de dollars et un EBITDA ajusté de 10 à 12 millions de dollars, tenant compte d'un impact unique de perte de revenus de 10 à 12 millions de dollars en raison de la perturbation de l'approvisionnement d'EGRIFTA SV®.
Theratechnologies (NASDAQ: THTX) berichtete über starke Finanzzahlen für das erste Quartal 2025 mit einem Gesamterlös von 19 Millionen Dollar, was einem Wachstum von 17,2 % im Vergleich zum Vorjahr entspricht. Das Unternehmen erzielte einen Nettogewinn von 117.000 Dollar und ein positives bereinigtes EBITDA von 2,3 Millionen Dollar.
Wichtige Höhepunkte sind:
- FDA-Zulassung von EGRIFTA WR™ zur Behandlung von überschüssigem viszeralem Bauchfett bei HIV-Patienten
- Verkäufe von EGRIFTA SV® stiegen um 44,8 % auf 13,9 Millionen Dollar
- Verkäufe von Trogarzo® sanken um 22,4 % auf 5,2 Millionen Dollar
- Behebung der vorübergehenden Lieferunterbrechung für EGRIFTA SV®
Das Unternehmen hat seine Prognose für das Geschäftsjahr 2025 aktualisiert und erwartet einen Umsatz zwischen 80 und 83 Millionen Dollar sowie ein bereinigtes EBITDA von 10 bis 12 Millionen Dollar, wobei ein einmaliger Einfluss von 10 bis 12 Millionen Dollar Umsatzverlust aufgrund der Lieferunterbrechung von EGRIFTA SV® berücksichtigt wird.
- Achieved net profit of $117,000 in Q1 2025, compared to loss of $4.48M in Q1 2024
- Total revenue grew 17.2% to $19M year-over-year
- EGRIFTA SV® sales increased 44.8% to $13.88M
- FDA approval of new EGRIFTA WR™ formulation
- Positive adjusted EBITDA of $2.3M vs -$247,000 in prior year
- Trogarzo® sales declined 22.4% to $5.17M due to new market competition
- Supply disruption expected to impact 2025 revenue by $10-12M
- Negative operating cash flow of $9.74M in Q1 2025
- Working capital to $2.67M as of February 28, 2025
Insights
Theratechnologies delivered a significant turnaround in Q1 2025, posting a net profit of $117,000 compared to a $4.48 million loss in Q1 2024, while growing revenue 17.2% to $19 million. This performance occurred despite a temporary supply disruption for EGRIFTA SV®, suggesting resilient product demand.
The FDA approval of EGRIFTA WR™ represents a crucial advancement, as this new formulation requires only weekly reconstitution versus daily preparation, potentially improving treatment adherence and expanding the franchise's market penetration. The company successfully navigated manufacturing challenges with the FDA approval of the Prior Approval Supplement for EGRIFTA SV®, allowing normal distribution to resume.
However, the financial outlook reveals mixed signals. While the impressive 44.8% growth in EGRIFTA SV® sales demonstrates strong demand, Trogarzo® continues declining (-22.4%) due to competitive pressures. Management expects a $10-12 million one-time revenue impact from the supply disruption, with projected 2025 revenue of $80-83 million.
The 74.4% gross margin reduction for EGRIFTA SV® (from 19.7% to 5.8% cost-to-revenue ratio) reflects improved manufacturing efficiency, though some benefit came from one-time provision reversals. The company's transition to profitability, combined with strategic product improvements and normalized operations, positions Theratechnologies for sustainable growth despite facing competitive challenges in its Trogarzo® franchise.
Theratechnologies' Q1 results demonstrate meaningful financial improvement with positive adjusted EBITDA of $2.3 million, compared to -$247,000 last year, and a return to profitability with $117,000 net profit versus a $4.48 million loss. This turnaround occurred despite operational challenges, highlighting improved operational efficiency.
The 17.2% revenue growth was driven by EGRIFTA SV®'s exceptional 44.8% increase, offsetting Trogarzo®'s 22.4% decline. However, the EGRIFTA SV® surge partially reflects inventory rebuilding following supply disruptions rather than organic growth. Operating expenses remained well-controlled with R&D expenses decreasing 21.2% to $2.97 million, though selling expenses increased 13.5%.
The company's financial position shows marked improvement with reduced interest expenses ($1.01 million vs $2.27 million) reflecting more favorable credit terms. Notably, management has resolved the going concern issue that previously existed, indicating stronger financial footing. With $3.91 million cash and positive working capital of $2.67 million, liquidity appears sufficient for near-term operations.
Forward guidance of $80-83 million revenue and $10-12 million adjusted EBITDA for 2025 accounts for the $10-12 million one-time revenue impact from supply disruptions. The anticipated Q2 revenue drawdown as pharmacy inventories normalize creates a temporary headwind, but the approval of EGRIFTA WR™ should drive longer-term growth. The company's return to profitability, improved debt structure, and product approvals collectively signal a positive financial trajectory despite ongoing competitive challenges for Trogarzo®.
- 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
____________________________
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
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 (
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
For the first quarter of Fiscal 2025, sales of EGRIFTA SV® reached
In the first quarter of Fiscal 2025, Trogarzo® sales amounted to
Cost of Goods Sold
In the first quarter of Fiscal 2025, cost of goods sold was
| Three months ended February | ||||||||
| Feb. 28, 2025 | Feb. 29 2024 | |||||||
| ( | % of Revenue | ( | % 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 (
R&D Expenses
R&D expenses in the three-month period ended February 28, 2025 amounted to
R&D expenses
(in thousands of dollars)
| Three months ended | |||
| Feb. 28 2025 | Feb. 29 2024 | % change | |
| Oncology | |||
| Laboratory research and personnel | 32 | 333 | - |
| Pharmaceutical product development | 48 | 113 | - |
| Phase 1 clinical trial | 85 | 389 | - |
| Medical projects and education | 206 | 226 | - |
| Salaries, benefits and expenses | 1,442 | 1,343 | |
| Regulatory activities | 457 | 431 | |
| Trogarzo® IM formulation | - | 20 | - |
| Tesamorelin formulation development | 572 | 604 | - |
| F8 human factor studies | (10) | 2 | -% |
| European activities | 11 | 2 | |
| Travel, consultants, patents, options, others | 320 | 303 | |
| Restructuring costs | - | 18 | - |
| Tax credits | (194) | (32) | |
| Total | 2,969 | 3,752 | - |
Selling Expenses
Selling expenses in the three-month period ended February 28, 2025, amounted to
General and Administrative Expenses
General and administrative expenses in the first quarter of Fiscal 2025 amounted to
Net Finance Costs
Net finance costs for the three-month period ended February 28, 2025, were
Adjusted EBITDA
Adjusted EBITDA was
Income Tax Expense
Income tax expense amounted to
Net Profit
Taking into account the revenue and expense variations described above, we recorded a net profit of
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
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
For the three-month period ended February 28, 2025, cash generated by operating activities before changes in operating assets and liabilities improved to
In the first quarter of fiscal 2025, changes in operating assets and liabilities had a negative impact on cash flow of
During the first quarter of 2025, cash used by operating activities amounted to
During the first quarter of 2025, cash provided by financing activities was
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 | ) | |
____________________________
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 | https://edge.media-server.com/mmc/p/coipg2gb |
| 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: 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 revenue guidance and Adjusted EBITDA guidance for Fiscal 2025; (ii) our expectations regarding the commercialization of EGRIFTA SV®, EGRIFTA WRTM and Trogarzo®; (iii) our ability and capacity to grow the sales of EGRIFTA SV®, EGRIFTA WRTM and Trogarzo® successfully in the United States and to meet our financial guidance; (iv) our capacity to meet supply and demand for our products; and (v) the market acceptance of EGRIFTA WRTM in the United States.
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) our revenue guidance and Adjusted EBITDA guidance for Fiscal 2025 will be met; (ii) sales of EGRIFTA SV®, EGRIFTA WRTM and Trogarzo® will grow over time; (iii) we will be successful in obtaining the reimbursement of EGRIFTA WRTM by public and private payors; (iv) we will have the ability to deliver EGRIFTA WRTM to pharmacies by July 2025; (v) our supplier of EGRIFTA SV® will be able to continue manufacturing this drug and will be able meet market demands for this product; (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) the Company’s ability and capacity to grow the sales of EGRIFTA SV®, EGRIFTA WRTM and Trogarzo® successfully in the United States; (ii) the Company’s capacity to meet supply and demand for its products; (iii) the market acceptance of EGRIFTA WRTM in the United States; (iv) the Company’s ability and capacity to provide pharmacies with EGRIFTA WRTM by July 2025; (v) the Company’s ability to obtain reimbursement coverage for EGRIFTA WRTM; (vi) the continuation of the Company’s collaborations and other significant agreements with its existing commercial partners and third-party suppliers and its ability to establish and maintain additional collaboration agreements; (vii) the Company’s success in continuing to seek and maintain reimbursements for EGRIFTA SV® and Trogarzo® by third-party payors in the United States; (viii) the success and pricing of other competing drugs or therapies that are or may become available in the marketplace; (ix) the discovery of a cure for HIV; (x) the Company’s failure to meet the terms and conditions set forth in the TD Credit Agreement and the IQ Credit Agreement resulting in an event of default and entitling the lenders to foreclose on all of our assets; (xi) unknown safety or efficacy issues with our approved drug products causing a decrease in demand for those products or a recall; (xii) non-approval of olezarsen and/or donidalorsen by Health Canada; (xiii) inability of the Company to find a partner to pursue the development of sudocetaxel zendusortide and/or its SORT1+ TechnologyTM platform; (xiv) dispute or litigation with third parties, including our suppliers; (xv) our incapacity to identify additional commercial assets or our inability to enter into commercial agreements regarding same on terms satisfactory to us; and (xvi) changes in our business plan.
We refer current and potential investors to the risk factors described under Item 3.D of our annual information form filed under 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
FAQ
What was Theratechnologies' (THTX) revenue growth in Q1 2025?
How much did EGRIFTA SV® sales increase in Q1 2025?
What is the impact of EGRIFTA SV® supply disruption on THTX's 2025 revenue?
What is THTX's revenue guidance for fiscal year 2025?
What are the key features of the newly approved EGRIFTA WR™?
