Theratechnologies Reports Strong Financial Results and Announces Positive Net Income for Third Quarter 2024
Theratechnologies reported strong Q3 2024 financial results with revenue of $22.6 million, up 8% year-over-year. The company achieved positive net income of $3.1 million or 6 cents per share, and Adjusted EBITDA of $7.2 million. EGRIFTA SV® sales grew 26.6% to $16.7 million, while Trogarzo® sales declined 22.9% to $5.9 million. The company revised its fiscal 2024 revenue guidance to $83-$85 million due to potential EGRIFTA SV® supply constraints, but increased Adjusted EBITDA guidance to $17-$19 million. Theratechnologies ended Q3 with $34.7 million in cash and $4.2 million in bonds/money market funds. The company faces some uncertainty around EGRIFTA SV® manufacturing and FDA approval timelines but expects to resume distribution in early 2025.
Theratechnologies ha riportato risultati finanziari solidi per il terzo trimestre del 2024 con ricavi di 22,6 milioni di dollari, in aumento dell'8% rispetto all'anno precedente. L'azienda ha raggiunto un utile netto positivo di 3,1 milioni di dollari, ovvero 6 centesimi per azione, e un EBITDA rettificato di 7,2 milioni di dollari. Le vendite di EGRIFTA SV® sono cresciute del 26,6%, arrivando a 16,7 milioni di dollari, mentre le vendite di Trogarzo® sono diminuite del 22,9%, attestandosi a 5,9 milioni di dollari. L'azienda ha revisionato le previsioni di ricavi per il 2024 tra gli 83 e gli 85 milioni di dollari a causa di potenziali vincoli nella fornitura di EGRIFTA SV®, ma ha aumentato le previsioni dell'EBITDA rettificato a 17-19 milioni di dollari. Theratechnologies ha chiuso il terzo trimestre con 34,7 milioni di dollari in contanti e 4,2 milioni di dollari in obbligazioni/fondi di mercato monetario. L'azienda affronta alcune incertezze riguardo ai tempi di produzione di EGRIFTA SV® e approvazione da parte della FDA, ma prevede di riprendere la distribuzione all'inizio del 2025.
Theratechnologies informó sobre resultados financieros sólidos para el tercer trimestre de 2024, con ingresos de 22,6 millones de dólares, un aumento del 8% interanual. La compañía logró un ingreso neto positivo de 3,1 millones de dólares, o 6 centavos por acción, y un EBITDA ajustado de 7,2 millones de dólares. Las ventas de EGRIFTA SV® crecieron un 26,6% hasta 16,7 millones de dólares, mientras que las ventas de Trogarzo® disminuyeron un 22,9% hasta 5,9 millones de dólares. La compañía revisó su guía de ingresos para el fiscal 2024 a entre 83 y 85 millones de dólares debido a posibles limitaciones de suministro de EGRIFTA SV®, pero aumentó la guía del EBITDA ajustado a entre 17 y 19 millones de dólares. Theratechnologies terminó el tercer trimestre con 34,7 millones de dólares en efectivo y 4,2 millones de dólares en bonos/fondos de mercado monetario. La compañía enfrenta cierta incertidumbre en torno a la fabricación de EGRIFTA SV® y los plazos de aprobación de la FDA, pero espera reanudar la distribución a principios de 2025.
Theratechnologies는 2024년 3분기 재무 결과가 2,260만 달러의 수익으로 역년 대비 8% 증가했다고 보고했습니다. 회사는 310만 달러의 긍정적인 순이익을 달성했으며, 주당 6센트를 기록했습니다. 그리고 조정된 EBITDA는 720만 달러였습니다. EGRIFTA SV®의 판매는 26.6% 증가한 1,670만 달러에 달했으며, Trogarzo®의 판매는 22.9% 감소하여 590만 달러에 불과했습니다. 회사는 2024 회계연도의 수익 지침을 수정했습니다. EGRIFTA SV® 공급 제약으로 인해 8,300만에서 8,500만 달러로 하향 조정했지만, 조정된 EBITDA 목표는 1,700만에서 1,900만 달러로 상향 조정했습니다. Theratechnologies는 3분기를 3,470만 달러의 현금과 420만 달러의 채권/머니 마켓 펀드로 마감했습니다. 회사는 EGRIFTA SV® 제조 및 FDA 승인 일정에 대한 불확실성이 있지만, 2025년 초에 배급을 재개할 것으로 예상하고 있습니다.
Theratechnologies a annoncé de solides résultats financiers pour le troisième trimestre 2024 avec des revenus de 22,6 millions de dollars, en hausse de 8 % par rapport à l'année précédente. L'entreprise a réalisé un bénéfice net positif de 3,1 millions de dollars, soit 6 cents par action, et un EBITDA ajusté de 7,2 millions de dollars. Les ventes d'EGRIFTA SV® ont augmenté de 26,6 % pour atteindre 16,7 millions de dollars, tandis que les ventes de Trogarzo® ont diminué de 22,9 % pour s'établir à 5,9 millions de dollars. L'entreprise a révisé ses prévisions de revenus pour l'exercice 2024 entre 83 et 85 millions de dollars en raison de potentielles contraintes d'approvisionnement concernant l'EGRIFTA SV®, mais a augmenté ses prévisions d'EBITDA ajusté à 17-19 millions de dollars. Theratechnologies a terminé le troisième trimestre avec 34,7 millions de dollars en liquidités et 4,2 millions de dollars en obligations/fonds de marché monétaire. L'entreprise fait face à certaines incertitudes concernant la fabrication d'EGRIFTA SV® et les délais d'approbation de la FDA, mais elle s'attend à reprendre la distribution début 2025.
Theratechnologies berichtete über starke Finanzzahlen für das dritte Quartal 2024 mit Einnahmen von 22,6 Millionen Dollar, was einem Anstieg von 8 % im Vergleich zum Vorjahr entspricht. Das Unternehmen erzielte einen positiven Nettogewinn von 3,1 Millionen Dollar, was 6 Cent pro Aktie entspricht, sowie ein bereinigtes EBITDA von 7,2 Millionen Dollar. Der Umsatz mit EGRIFTA SV® stieg um 26,6 % auf 16,7 Millionen Dollar, während der Umsatz mit Trogarzo® um 22,9 % auf 5,9 Millionen Dollar zurückging. Das Unternehmen hat seine Umsatzprognose für das Geschäftsjahr 2024 revidiert und erwartet Einnahmen zwischen 83 und 85 Millionen Dollar aufgrund möglicher Engpässe bei der EGRIFTA SV®-Lieferung, hat jedoch die Prognose für das bereinigte EBITDA auf 17 bis 19 Millionen Dollar angehoben. Theratechnologies schloss das dritte Quartal mit 34,7 Millionen Dollar in bar und 4,2 Millionen Dollar in Anleihen/Geldmarktfonds ab. Das Unternehmen sieht sich einigen Ungewissheiten bezüglich der Herstellung von EGRIFTA SV® und des Zeitplans für die FDA-Zulassung gegenüber, erwartet jedoch, dass die Verteilung Anfang 2025 wieder aufgenommen wird.
- Revenue increased 8% year-over-year to $22.6 million in Q3 2024
- Achieved positive net income of $3.1 million or $0.06 per share in Q3
- Adjusted EBITDA improved to $7.2 million in Q3 2024
- EGRIFTA SV® sales grew 26.6% year-over-year to $16.7 million
- Increased fiscal 2024 Adjusted EBITDA guidance to $17-$19 million
- Cash flow from operating activities improved by $5.3 million year-over-year
- Trogarzo® sales declined 22.9% year-over-year to $5.9 million
- Revised fiscal 2024 revenue guidance down to $83-$85 million due to potential EGRIFTA SV® supply constraints
- Risk of temporary EGRIFTA SV® supply disruption in early 2025 due to manufacturing issues
- Uncertainty around FDA approval timeline for resuming EGRIFTA SV® distribution
- Potential covenant breaches in credit agreement if unable to meet financial targets
Insights
Theratechnologies has delivered a strong financial performance in Q3 2024, marking a significant turnaround from previous periods. Key highlights include:
- Revenue growth of
8.4% year-over-year to$22.6 million - Positive net income of
$3.1 million or$0.06 per share - Adjusted EBITDA of
$7.2 million , a substantial improvement - EGRIFTA SV® sales up
26.6% year-over-year
The company has revised its fiscal 2024 guidance, now expecting revenue between
While Trogarzo® sales have declined, the overall financial health of the company has improved significantly, with better cost management and operational efficiency. The positive net income and strong Adjusted EBITDA demonstrate a shift towards profitability, which is important for the company's long-term sustainability.
Theratechnologies' pipeline developments show promise, particularly in the advancement of their F8 formulation and oncology program:
- The company is addressing FDA questions on the sBLA for the F8 formulation, with submission expected by end of November
- The Phase 1 clinical trial of sudocetaxel zendusortide in advanced ovarian cancer is progressing without reported dose-limiting toxicities
- R&D expenses have decreased significantly, reflecting a more focused approach to development
The potential supply disruption for EGRIFTA SV® is a concern, but the company appears to be managing it proactively. The planned resumption of manufacturing in October and the filing of a Prior Approval Supplement with the FDA indicate a clear path forward.
The company's strategic focus on North American markets and partnerships could lead to new opportunities for growth. However, the success of these initiatives and the timely resolution of the EGRIFTA SV® supply issue will be critical for maintaining momentum in both commercial and clinical development areas.
- Q3 revenue of
$22.6 million represents +8% growth year-over-year - Positive net income of
$3.1 million or 6 cents per share, and Adjusted EBITDA1 of$7.2 million - Fiscal 2024 guidance revised to between
$83 and$85 million in revenue and Adjusted EBITDA guidance increased to a range of$17 t o$19 million
MONTREAL, Oct. 10, 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 third quarter of fiscal year 2024 ended August 31, 2024 (Q3 2024). All figures are in US dollars unless otherwise stated.
Revenue for the three- and nine-month periods ended August 31, 2024
(in thousands of dollars)
| Three months ended August 31 | % change | Nine months ended August 31 | % change | |||||
| 2024 | 2023 | 2024 | 2023 | |||||
| EGRIFTA SV® net sales | 16,687 | 13,183 | 26.6 | % | 42,473 | 36,747 | 15.6 | % |
| Trogarzo® net sales | 5,913 | 7,672 | (22.9 | %) | 18,391 | 21,565 | (14.7 | %) |
| Revenue | 22,600 | 20,855 | 8.4 | % | 60,864 | 58,312 | 4.4 | % |
“I am pleased to wrap up this third quarter with a strong Adjusted EBITDA of
“We have doubled down on our efforts to enter into partnerships and to find innovative products to market, making significant progress in both in the U.S. and in Canada. Our North American focused strategy is clear, and we are well-positioned to achieve our long-term objective of delivering sustained top-line and bottom-line growth. In terms of our pipeline, we remain committed to bringing the F8 formulation to market and have now addressed all questions from the FDA on the sBLA related to immunogenicity and microbiology. We expect to have the file completed shortly with a plan to submit it to the FDA by the end of November. In oncology, we continue to be focused on generating results from Part 3 of our Phase 1 clinical trial of sudocetaxel zendusortide in advanced ovarian cancer and have had no reports of DLTs, including neuropathy and eye toxicities. One final patient remains in the trial and we plan to share results once their treatment is completed and all data can be analyzed.”
Recent Events:
Company Announced a Risk of a Temporary Supply Disruption for EGRIFTA SV® in Early 2025
On September 17, 2024, the Company announced a risk of a temporary supply disruption for EGRIFTA SV® in early 2025 caused by an unexpected voluntary shutdown of the Company’s contract manufacturer’s facility following an inspection by the FDA, as well as the FDA review timeline to resume distribution of the product. The Company has since implemented measures to carefully manage the inventory levels of EGRIFTA SV® to meet patient demand until mid-January 2025 and these measures will result in a revenue shortfall for EGRIFTA SV® in fiscal year 2024. See “Revised Fiscal 2024 Revenue and Adjusted EBITDA Guidance” below. The manufacturer is finalizing its remediation measures and has confirmed to the Company that it plans to resume activities by mid-October. Based on these timelines, a batch of EGRIFTA SV® is currently scheduled to be manufactured in the week of October 21, 2024.
Revised Fiscal 2024 Revenue and Increased Adjusted EBITDA Guidance
Theratechnologies anticipated Fiscal 2024 revenue guidance range is revised to between
Third Quarter Fiscal 2024 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 nine-month periods ended August 31, 2024 (“Third Quarter Fiscal 2024”) which have been prepared in accordance with International Accounting Standard (“IAS”) 34, Interim Financial Reporting of 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 used have the meaning ascribed thereto in the Company’s MD&A.
Revenue
For the three- and nine-month periods ended August 31, 2024, consolidated revenue was
For the third quarter of Fiscal 2024, net sales of EGRIFTA SV® were
Trogarzo® net sales in the third quarter of Fiscal 2024 amounted to
For the nine-month period ended August 31, 2024, Trogarzo® net sales were
Cost of Sales
For the three- and nine-month periods ended August 31, 2024, cost of sales was
Cost of Sales
| Three months ended August 31 | Nine months ended August 31 | |||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||
| ( | % of Revenue | ( | % of Revenue | ( | % of Revenue | ( | % of Revenue | |||||
| EGRIFTA SV® | 1,465 | 8.8 | % | 1,059 | 8.0 | % | 4,901 | 11.5 | % | 3,285 | 8.9 | % |
| Trogarzo® | 3,056 | 51.7 | % | 3,908 | 50.9 | % | 9,451 | 51.4 | % | 11,284 | 52.3 | % |
| Total | 4,521 | 20.0 | % | 4,967 | 23.8 | % | 14,352 | 23.6 | % | 14,569 | 25.0 | % |
For the nine-month period ended August 31, 2024, EGRIFTA SV® cost of sales was negatively affected by a
R&D Expenses
R&D expenses in the three- and nine-month periods ended August 31, 2024, amounted to
R&D expenses
(in thousands of dollars)
| Three months ended August 31 | Nine months ended August 31 | ||||||
| 2024 | 2023 | % change | 2024 | 2023 | % change | ||
| Oncology | |||||||
| Laboratory research and personnel | 78 | 436 | - | 1,444* | 1,424 | ||
| Pharmaceutical product development | 60 | 67 | - | 217 | 4,410 | - | |
| Phase 1 clinical trial | 493 | 204 | 1,470 | 1,806 | - | ||
| Medical projects and education | 187 | 785 | - | 691 | 3,167 | - | |
| Salaries, benefits and expenses | 1,201 | 2,142 | - | 3,815 | 7,263 | - | |
| Regulatory activities | 367 | 366 | - | 1,174 | 1,164 | - | |
| Trogarzo® IM formulation | - | 115 | - | 26 | 965 | - | |
| Tesamorelin formulation development | 350 | 80 | 1,402 | 1,201 | |||
| F8 human factor studies | 5 | 534 | - | 12 | 1,147 | - | |
| Pen injector | - | - | - | - | 234 | - | |
| European activities | 53 | 117 | - | 105 | 456 | - | |
| Travel, consultants, patents, options, others | 329 | 350 | - | 973 | 1,824 | - | |
| Restructuring costs | 185 | 509 | - | 521 | 509 | ||
| Tax credits | (696) | (309) | (761) | (429) | |||
| Total | 2,612 | 5,396 | -52% | 11,089 | 25,141 | -56% | |
*Including accelerated depreciation (
R&D expenses in the second quarter of 2023 were negatively impacted by a provision of
Selling Expenses
Selling expenses decreased to
The amortization of the intangible asset value for the EGRIFTA SV® and Trogarzo® commercialization rights is also included in selling expenses. As such, the Company recorded amortization expense of
General and Administrative Expenses
General and administrative expenses in the three- and nine-month periods ended August 31, 2024, amounted to
Adjusted EBITDA
Adjusted EBITDA was
Net Finance Costs
Net finance costs for the three- and nine-month periods ended August 31, 2024, were
Net finance costs for the three- and nine-month periods ended August 31, 2024, also included accretion expense of
Income Taxes
During the three- and nine-month periods ended August 31, 2024, income tax expenses amounted to
Net Income (Loss)
As a result of stronger revenues and the tight management of expenses over the past year, net income for the third quarter ended August 31, 2024, amounted to
Financial Position, Liquidity and Capital Resources
Liquidity and Going Concern
As part of the preparation of the Interim Consolidated Financial Statements, management is responsible for identifying events or conditions that indicate a material uncertainty exists that casts substantial doubt on the Company’s ability to continue to honor its obligations as they fall due during a period of at least, but not limited to, 12 months from August 31, 2024. If the Company concludes that events or conditions indicate material uncertainty exists on its ability to continue as a going concern, it must assess whether management’s plans developed to mitigate these events or conditions address the material uncertainty.
For the nine-month period ended August 31, 2024, the Company generated a net loss of
The Company’s Marathon Credit Agreement (as defined in Note 7 of the Interim Financial Statements) contains various covenants, including minimum liquidity covenants whereby the Company needs to maintain significant cash, cash equivalent and eligible short-term investments balances in specified accounts, which restricts the management of the Company’s liquidity (refer to Note 7 of the Interim Financial Statements). As at August 31, 2024, the material covenants of the Marathon Credit Agreement include: (i) minimum liquidity of
On September 17, 2024, the Company announced a risk of a temporary supply disruption for EGRIFTA SV® in early 2025 caused by an unexpected voluntary shutdown of the Company’s contract manufacturer’s facility following an inspection by the FDA, as well as the FDA review timeline to resume distribution of the product. The manufacturer is finalizing its remediation measures and has confirmed to the Company that it plans to resume activities by mid-October. Based on these timelines, a batch of EGRIFTA SV® is currently scheduled to be manufactured in the week of October 21, 2024. In order to resume distribution of EGRIFTA SV®, the Company was requested by the FDA to file a Prior Approval Supplement (“PAS”) describing the changes made by its manufacturer. The Company plans to file the PAS in early November 2024. A PAS is usually reviewed by the FDA within four months of receipt.
The Company’s ability to continue generating revenues through the sale of EGRIFTA SV® and to be able to meet the Marathon Adjusted EBITDA targets for a period of at least, but not limited to, 12 months from August 31, 2024, involves significant judgement and is dependent on the resumption of the manufacture and distribution of EGRIFTA SV® by the end of the first quarter of fiscal 2025, which is dependant on the release to the market of the new batch of EGRIFTA SV®. This also involves management of expenses to remain in compliance with the conditions of the Marathon Credit Agreement. The Company would need to obtain the support of the lender (including possible waivers and amendments, if necessary) in the event of a breach of the covenants in the Marathon Credit Agreement. Should management’s plans not materialize, the Company may be in default under the Marathon Credit Agreement, be forced to reduce or delay expenditures and capital additions and seek additional alternative financing, or sell or liquidate its assets. Portions of management’s plans are outside of their control such as the timing of resumption of product distribution which requires FDA approval. Therefore, there are scenarios wherein events or conditions combine to create material uncertainty and cast substantial doubt about the Company’s ability to continue as a going concern.
The Interim Consolidated 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. The Interim Consolidated Financial Statements do not include any adjustments to the carrying values and classification of assets and liabilities and reported expenses that might result from the outcome of this uncertainty and that may be necessary if the going concern basis was not appropriate for the Interim Consolidated Financial Statements. If the Company was unable to continue as a going concern, material impairment of the carrying values of the Company’s assets, including intangible assets, could be required.
Analysis of cash flows
Theratechnologies ended the third quarter of Fiscal 2024 with
For the three-month period ended August 31, 2024, cash flow from operating activities before changes in operating assets and liabilities improved to
In the third quarter of Fiscal 2024, changes in operating assets and liabilities had a positive impact on cash flow of
During the third quarter of Fiscal 2024, cash flows from financing activities used
Non-IFRS and Non-U.S. GAAP Measure
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, income taxes, share-based compensation from stock options, 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 Corporation to which the measure relates and might not be comparable to similar financial measures disclosed by other issuers. A quantitative reconciliation of the Adjusted EBITDA is presented in the table below:
Reconciliation of Adjusted EBITDA
(In thousands of dollars)
| Three-month periods ended August 31 | Nine-month periods ended August 31 | ||||||
| 2024 | 2023 | 2024 | 2023 | ||||
| Net income (loss) | 3,091 | (746 | ) | (403 | ) | (21,202 | ) |
| Add : | |||||||
| Depreciation and amortization2 | 489 | 868 | 2,268 | 2,739 | |||
| Net Finance costs3 | 2,366 | 674 | 6,674 | 7,557 | |||
| Income tax expense | 756 | 126 | 984 | 348 | |||
| Share-based compensation | 387 | 519 | 1,354 | 1,797 | |||
| Inventory provision4 | - | - | 1,088 | 170 | |||
| Restructuring costs | 150 | 719 | 486 | 719 | |||
| Adjusted EBITDA | 7,239 | 2,160 | 12,451 | (7,872 | ) | ||
Conference Call Details
The call will be held on Thursday, October 10 at 8:30 a.m. ET and will be hosted by Paul Lévesque, President and Chief Executive Officer. He 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 who 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 | October 10, 2024 |
| Conference Call Time | 8:30 a.m. ET |
| Webcast link | https://edge.media-server.com/mmc/p/vy4y3hwc |
| Dial in | 1-888-513-4119 (toll free) or 1-412-902-6615 (international) |
| Access Code | 5313857 |
| CONFERENCE CALL REPLAY | |
| Toll Free | 1-877-344-7529 (US) / 1-855-669-9658 (Canada) |
| International Toll | 1-412-317-0088 |
| Replay Access Code | 2159194 |
| Replay End Date | October 17, 2024 |
| 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 biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs. 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 Twitter.
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 our revised 2024 fiscal year revenue and Adjusted EBITDA guidance, heightened sales from EGRIFTA SV® in the first quarter of 2025, our strategy to achieve our long-term objective of delivering sustained top-line and bottom-line growth, the supply disruption of EGRIFTA SV®, the resumption of the manufacturing of a batch of EGRIFTA SV®, the timelines associated to the filing of a PAS with the FDA, the review timelines of a PAS by the FDA, the resubmission with the FDA of the sBLA for the F8 Formulation, the publication of results from Part 3 of our Phase 1 clinical trial studying sudocetaxel zendusortide in advanced ovarian cancer and the conclusion of partnerships to market new products. 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) we will meet our revised revenue and Adjusted EBITDA guidance; (ii) we will manage inventory to avoid or limit an EGRIFTA SV® shortage to patients in early 2025; (iii) sales of EGRIFTA SV® will ramp up in 2025; (iv) we will control expenses as planned and no unforeseen events will occur which would have the effect of increasing our expenses in 2024 and beyond; (v) our third-party manufacturer will complete its remediation measures by mid-October and all results from various tests required to resume manufacturing will allow such manufacturer to resume its activities to manufacture a batch of EGRIFTA SV® in the week of October 21, 2024; (vi) we will obtain from our manufacturer all of the necessary information to file a PAS within the timelines set forth herein; (vii) the FDA will have no comment on our PAS within the prescribed timelines and, if any, we will be able to answer those within such timelines; (viii) the batch of EGRIFTA SV® to be manufactured in October 2024 will meet specifications for market release; (ix) the resubmission with the FDA of the sBLA for the F8 Formulation will be done within the announced timelines and the FDA will approve such sBLA; (x) we will be in compliance with the terms and conditions of the Credit Agreement; (xi) we will be able to generate positive results from Part 3 of our Phase 1 clinical trial studying sudocetaxel zendusortide in advanced ovarian cancer; (xii) we will be able to enter into partnerships to expand our portfolio of commercial products; (xiii) no event will occur that would prevent us from executing the objectives set forth in this press release; and (xiv) we will continue as a going concern. 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) a shortage of EGRIFTA SV® in mid-January 2025; (ii) decline in sales of EGRIFTA SV® in 2025; (iii) a delay by our third-party manufacturer to implement and/or complete its remediation measures to resume its manufacturing activities, including the manufacture of a batch of EGRIFTA SV® in October 2024; (iv) the new batch of EGRIFTA SV® not meeting the specifications for release to the market; (v) a delay in the filing by the Company of a PAS; (vi) the receipt by the Company of a “Refuse to File” letter from the FDA following the filing of its PAS or the issuance of information requests by the FDA during the review period of the PAS leading to a delay in releasing the newly manufactured batch of EGRIFTA SV®; (vii) a delay in submitting the sBLA for the F8 Formulation and/or the non-approval by the FDA of such sBLA; (viii) the Company’s failure to meet the covenants, obligations and various undertakings contained in the Credit Agreement which could lead to interest rate increase on the loaned amounts and/or the foreclosure by the secured lender of al of the assets of the Company; (ix) our inability to find products to add to our portfolio or to enter into agreements the terms and conditions of which would be satisfactory to us; and (x) the occurrence of events which would lead us to spend more cash than anticipated, the effect of which could result in a lower than announced Adjusted EBITDA. We refer current and potential investors to the “Risk Factors” section of our Annual Information Form in the form of a Form 20-F Annual Report dated February 21, 2024, 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:
Philippe Dubuc
Senior Vice President and Chief Financial Officer
pdubuc@theratech.com
1-438-315-6608
Media inquiries:
Julie Schneiderman
Senior Director, Communications & Corporate Affairs
communications@theratech.com
1-514-336-7800
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.
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 and amortization of deferred financing costs, interest expense, bank charges, gain or loss on financial instruments carried at fair value and loss on debt modification and gain on lease termination.
4 Inventory provision pending marketing approval of the F8 Formulation.
FAQ
What was Theratechnologies' (THTX) revenue for Q3 2024?
Did Theratechnologies (THTX) achieve profitability in Q3 2024?
What is Theratechnologies' (THTX) revised revenue guidance for fiscal 2024?
Why did Theratechnologies (THTX) revise its 2024 revenue guidance?
What was the performance of EGRIFTA SV® sales for Theratechnologies (THTX) in Q3 2024?
