Theratechnologies Reports Strong Financial Results and Announces Positive Net Income for Third Quarter 2024

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 to $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 monthsended 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 $7.2 million and a net profit of $3.1 million," said Paul Lévesque, President and Chief Executive Officer at Theratechnologies. "Quarter after quarter, we have continued to demonstrate strength on the bottom line and as such are increasing Adjusted EBITDA guidance to $17 to $19 million dollars. EGRIFTA SV® remains our engine of growth, recording its best performance in recent history by capturing new patients and prescribers at an unprecedented level over the past nine months. Considering current trends for Trogarzo®, and as a result of the potential constrained supply of EGRIFTA SV® anticipated in late November, we are changing topline guidance to between $83 and $85 million. We believe that in the first part of 2025 we will fully make up for sales not recorded in the fourth quarter of 2024 and remain confident that any impact on patients will be avoided.

"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 $83 and $85 million from $87 to $90 million. The Company hereby also increases Adjusted EBITDA guidance, a non-IFRS measure, to be between $17 and $19 million from $13 to $15 million for Fiscal 2024. This increase is supported by the Company's continued focus on controlling expenses, as evidenced by the strong performance of the first three quarters of 2024. The revised revenue guidance takes into consideration the revenue shortfall due to the potential supply constraint of EGRIFTA SV® in late November and the year-to-date trend of Trogarzo® sales.

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 $22,600,000 and $60,864,000, compared to $20,855,000 and $58,312,000 for the same periods ended August 31, 2023, representing a year-over-year increase of 8.4% for the third quarter and an increase of 4.2% for the first nine months of the fiscal year.

For the third quarter of Fiscal 2024, net sales of EGRIFTA SV® were $16,687,000 compared to $13,183,000 in the third quarter of fiscal 2023, representing an increase of 26.6% year-over-year.  Stronger sales of EGRIFTA SV® in the third quarter of 2024 compared to the same period last year were mostly the result of strong unit demand for the product, combined with a higher net selling price than last year. Net sales for the nine-month period ended August 31, 2024 amounted to $42,473,000 compared to $36,747,000 in the same period in 2023, representing growth of 15.6%.

Trogarzo® net sales in the third quarter of Fiscal 2024 amounted to $5,913,000 compared to $7,672,000 for the same quarter of 2023, representing a decrease of 22.9% year-over-year.  Lower sales of Trogarzo® were mostly the result of lower unit sales due to competitive pressures in the multidrug-resistant segment of the HIV-1 market, where Trogarzo remains an important part of the treatment arsenal but has lost market share to market leaders in the segment.

For the nine-month period ended August 31, 2024, Trogarzo® net sales were $18,391,000 compared to $21,565,000 in the same period in 2023. 

Cost of Sales

For the three- and nine-month periods ended August 31, 2024, cost of sales was $4,521,000 and $14,352,000 compared to $4,967,000 and $14,569,000 for the same periods in fiscal 2023.

Cost of Sales

 

Three monthsended August 31

Nine months ended August 31

 

2024

 

2023

 

2024

 

2023

 

 

($000s)

% of Revenue

($000s)

% of Revenue

($000s)

% of Revenue

($000s)

% 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 ...