- Q3 FY2021 consolidated sales grow 27% over Q3 FY2020 –
- Ongoing Part A of Phase 1 program evaluating TH1902 for sortilin-expressing cancers indicating better tolerability than docetaxel alone –
“We are excited for the progress that has been achieved to date across our R&D and commercial portfolios,” said
“In line with our NASH development strategy, we continue to explore opportunities to best execute the Phase 3 clinical trial evaluating tesamorelin, including seeking a partnership for this program,” continued
Third-Quarter 2021 Revenues
(in thousands of
Three Months Ended | % change | ||
2021 | 2020 | ||
EGRIFTA®, EGRIFTA SV® net sales | 11,224 | 6,864 | 64% |
Trogarzo® net sales | 6,628 | 7,185 | -8% |
Revenue | 17,852 | 14,049 | 27% |
“On the commercial front, we believe our operational improvements in digital marketing and disease education have created a springboard for growth for our approved medicines with sales increasing 27% over the year primarily supported by a 64% increase in EGRIFTA SV® sales. We have also made progress toward securing pricing and reimbursement for Trogarzo® in several European countries including
Pipeline Updates
- TH1902 Study Update: The Company’s Phase 1 study evaluating its novel investigational proprietary peptide-drug conjugate (PDC) TH1902 for the treatment of sortilin-positive cancers is progressing as planned. To date, the study has dosed several patients with tumors for which no known effective therapies exist, with some receiving more docetaxel, when conjugated to TH1902, than the indicated dose of docetaxel alone (80-100mg/m2). Patients that have received up to 300mg/m2 of TH1902 (the equivalent of 130mg/m2 of docetaxel), or approximately 1.5 times the indicated dose of docetaxel, have not experienced any grade 2 adverse events. The last patient dosed received 420mg/m2 of TH1902, or approximately 2 times the indicated dose of docetaxel, and experienced a grade 4 adverse event (neutropenia). The Company is awaiting all safety information to assess the next dosing level and to pursue the study as per the protocol. Part A of the Phase 1 trial is ongoing until the maximum tolerated dose (MTD) is identified. Theratechnologies’ expects to provide another update on the Phase 1/Part A study when it has reached MTD of TH1902.
- Phase 3 Development of Tesamorelin for NASH: The Company continues to evaluate its opportunities to most effectively execute its Phase 3 development program evaluating tesamorelin for the treatment of nonalcoholic steatohepatitis (NASH), including seeking a potential partner.
Theratechnologies previously announced that an externalU.S. -based biopharma advisory firm was retained to assist in identifying a potential partnership for this program. OnSeptember 13, 2021 ,Theratechnologies hosted a virtual NASH event featuring key opinion leaders (KOLs) in hepatology and NASH, which was well-attended. - Lifecycle Management for Treatment of HIV: Based on an internal data assessment, the TMB-302 study evaluating an intravenous (IV) Push mode of administration of Trogarzo® for the treatment of human immunodeficiency virus type 1 (HIV-1) infection achieved consistent and statistically significant results demonstrating that there was no difference in pharmacokinetics (PK) between IV Push and IV Infusion. This more convenient IV Push mode of administration may offer patients a rapid infusion time and requires only two quick infusions per month potentially increasing patient compliance and thereby allowing patients to benefit from long-acting protection against HIV-1 when Trogarzo® is administered with other antiretrovirals. Based on these results, a supplemental Biologics License Application (sBLA) is expected to be filed with the
U.S. Food and Drug Administration (FDA) in the fourth quarter of 2021.Theratechnologies and TaiMed Biologics Inc. are also evaluating an intramuscular (IM) method of administration for Trogarzo® within the TMB-302 study. Patient screening for the IM study is planned for the fourth quarter of Fiscal 2021. - TH1902 Preclinical Data Published in
Peer-Reviewed Journal , Cancer Science: Preclinical research of TH1902 for the treatment of sortilin-positive triple negative breast cancer (TNBC) was published in the peer-reviewed journal Cancer Science, confirming the in vivo efficacy and safety of TH1902 against TNBC through a SORT1 receptor-mediated mechanism. This research also further supports sortilin as a potential targetable biomarker for hard-to-treat cancers. - New Preclinical Findings for TH1902 for Potential Treatment of Metastatic Cancers: In
June 2021 , the Company announced new preclinical in vivo findings on the anti-metastatic effect and tolerability of TH1902. If confirmed in humans, the Company believes TH1902 could be used in the treatment of metastasis.
Commercial Updates
- Trogarzo® Pricing Agreement in
Italy :Theratechnologies and theItalian Medicines Agency , AIFA, have reached a pricing and reimbursement agreement for Trogarzo®. The Company expects Trogarzo to be commercially available to all eligible patients inItaly before the end of 2021. - Trogarzo® PROMISE Study: The Company is initiating a post-authorization study in the
European Union (EU) evaluating the real-world long-term efficacy and safety of Trogarzo® in combination with other antiretrovirals. The study, named Prospective and Retrospective, Observational Multicenter Ibalizumab Study of Efficacy (PROMISE), is expected to enroll patients in the EU in the fourth quarter of 2021. A similar study, which is intended to collect real-world clinical data of Trogarzo® in theU.S. (PROMISE-US), is expected to begin in theU.S. in the first quarter of 2022.
Corporate Updates
- Appointment of
Mace Rothenberg , M.D. as Oncology Advisor:Theratechnologies recently appointedMace Rothenberg , M.D. as a scientific advisor for the Company’s SORT1+ Technology™ oncology platform.Dr. Rothenberg brings more than 30 years of experience across government, academia and the biopharmaceutical industry, most recently serving as Chief Medical Officer (CMO) at Pfizer before his retirement earlier this year. During his time at Pfizer as CMO, the company initiated, completed and obtained emergency use authorization for its COVID-19 vaccine and obtained regulatory approval for 11 new cancer medicines.Dr. Rothenberg is a Fellow of theAmerican College of Physicians and theAmerican Society of Clinical Oncology . - New At-The-Market Facility Established: On
July 23, 2021 , the Company announced that it established an at-the-market (ATM) equity program allowingTheratechnologies to issue and sell up to US$50 million of common shares from treasury to the public at the Company’s sole discretion and at the prevailing market price. - New Board Member Appointed: In
June 2021 , the Company appointed Mr.Frank Holler as an independent member to its Board of Directors.Mr. Holler is a recognized biotechnology industry leader with expertise in capital markets.
Third-Quarter Fiscal 2021 Financial Results
Revenue
Consolidated revenue for the three and nine-month periods ended
Revenue for the third quarter of 2021 were up 27% compared to the third quarter of 2020. Most of that growth was attributable to strong EGRIFTA SV® revenues, which increased 64% over the same quarter last year. The strong third-quarter performance for EGRIFTA SV® was related to higher unit sales and a higher selling price and were also supported by stronger new prescriptions, a sign of a return to pre-COVID-19 levels. Sales of Trogarzo® were down 7.8% compared to the third quarter of last year. Lower unit sales were somewhat offset by a higher selling price and were the result of lower patient access to hospitals and clinics because of COVID-19, as well as the impact of a new competitor.
Cost of Sales
For the three- and nine-month periods ended
R&D Expenses
R&D expenses for the three- and nine-month periods ended
The increase was largely due to the development of our oncology platform, the preparation of our Phase 3 trial for tesamorelin in the treatment of NASH, the F8 formulation and the multi-dose pen injector, as well as regulatory expenses and increased medical education initiatives in
Selling Expenses
Selling expenses increased to
The increase was mainly associated with increased activities in
General and Administrative Expenses
General and administrative expenses in the three- and nine-month periods ended
The increase in general and administrative expenses was mainly associated with an overall increase in business activities, senior hires to support our sales activities in the
Net Finance Costs
Net finance costs for the three- and nine-month periods ended
The change in finance income and finance costs in 2021 versus the comparable periods in 2020 was mostly due to foreign currency variations. We recorded a net foreign currency loss of
Finance costs also included accretion expense, which was
Adjusted EBITDA
For the reasons noted above, Adjusted EBITDA, which is a non-GAAP measure, for the three- and nine- month periods ended
Net loss
Taking into account the revenue and expense variations described above, we recorded a net loss of
Financial Position
For the three- and nine-month periods ended
In the third quarter of Fiscal 2021, changes in operating assets and liabilities had a positive impact on cash flow of
In the first nine months of Fiscal 2021, changes in operating assets and liabilities positively affected cash flow by
As of
Non-IFRS Financial Measures
Reconciliation of net profit or loss to adjusted earnings before interest, taxes, depreciation and amortization (Adjusted EBITDA)
Adjusted EBITDA is a non-IFRS financial measure. A reconciliation of the Adjusted EBITDA to net loss is presented in the table below. We use adjusted financial measures to assess our operating performance. Securities regulations require that companies caution readers that earnings and other measures adjusted to a basis other than IFRS do not have standardized meanings and are unlikely to be comparable to similar measures used by other companies. Accordingly, they should not be considered in isolation. We use Adjusted EBITDA to measure operating performance from one period to the next without the variation caused by certain adjustments that could potentially distort the analysis of trends in our business, and because we believe it provides meaningful information on our financial condition and operating results.
We obtain our Adjusted EBITDA measurement by adding to net profit or loss, finance income and costs, depreciation and amortization, and income taxes. We also exclude the effects of certain non-monetary transactions recorded, such as share-based compensation and write-downs (or related reversals) of inventories, for our Adjusted EBITDA calculation. We believe it is useful to exclude these items as they are either non-cash expenses, items that cannot be influenced by management in the short term, or items that do not impact core operating performance. Excluding these items does not imply they are necessarily nonrecurring. Share-based compensation costs are a component of employee remuneration and can vary significantly with changes in the market price of the Company’s shares. In addition, other items that do not impact core operating performance of the Company may vary significantly from one period to another. As such, Adjusted EBITDA provides improved continuity with respect to the comparison of our operating results over a period of time. Our method for calculating Adjusted EBITDA may differ from that used by other companies.
Adjusted EBITDA
(In thousands of
Three-month periods ended | Nine-month periods ended | |||||
2021 | 2020 | 2021 | 2020 | |||
Net loss | (9,510) | (6,768) | (21,824) | (17,118) | ||
Add (deduct): | ||||||
Depreciation and amortization | 2,189 | 2,189 | 6,559 | 6,328 | ||
Net finance costs | 2,254 | 799 | 4,609 | 3,270 | ||
Share-based compensation | 401 | 349 | 1,527 | 1,168 | ||
Write-down of inventories | - | 282 | - | 676 | ||
Income taxes | 18 | - | 44 | - | ||
Adjusted EBITDA | (4,648) | (3,149) | (9,085) | (5,676) |
Conference Call Details
A conference call and webcast will be held on
The conference call can be accessed by dialing 1-844-400-1697 (toll free) or 1-703-736-7400 (International). The conference call will also be accessible via webcast here. An audio replay of the conference call will be available on the same day starting at
About
Forward-Looking Information
This press release contains forward-looking statements and forward-looking information, or, 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", “promising”, “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 the conduct of our clinical trials with TH1902 and tesamorelin, the results expected to be obtained from the conduct of these clinical trials, the timelines associated with the filing of an sBLA with the FDA and the beginning of the screening of patients for the IM study, and the growth of our revenues from sales of EGRIFTA SV® and Trogarzo®.
Although the forward-looking information contained in this press release is based upon what the Company believes are reasonable assumptions in light of the information currently available, investors are cautioned against placing undue reliance on this information since actual results may vary from the forward-looking information. Certain assumptions made in preparing the forward-looking statements include that: the current COVID-19 pandemic will have limited adverse effect on the Company’s operations; sales of EGRIFTA SV® and Trogarzo® in
Forward-looking information 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 information. These risks and uncertainties include, but are not limited to, those related to or arising from: the adverse impact of the COVID-19 pandemic on (a) the Company’s sales efforts and sales initiatives, (b) the capacity of the Company’s suppliers to meet their obligations vis-à-vis the Company, (c) the Company’s research and development activities, (d) the health of the Company’s employees and its capacity to rely on its resources, as well as (e) global trade; the Company’s ability and capacity to grow the sales of EGRIFTA SV® and Trogarzo® successfully in
We refer current and potential investors to the “Risk Factors” section of our Annual Information Form dated
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.
For media and investor inquiries:
Senior Director, Investor Relations
communications@theratech.com
617-356-1009
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