Theratechnologies Inc. (Theratechnologies, or Company) (TSX: TH)
(NASDAQ: THTX), a biopharmaceutical company focused on the
development and commercialization of innovative therapies, today
announced its financial results for the fourth quarter and its
fiscal year ended November 30, 2020 (Fiscal 2020).
“2020 marked a transformative year for
Theratechnologies that included significant and swift advancements
to our pipeline and growing revenues. Despite the global pandemic,
we filed two investigational new drug applications for our oncology
and NASH programs and recognized record sales for our HIV business.
Entering 2021, this momentum has continued as we received
“study-may-proceed” letters for both pipeline programs and a fast
track designation for our lead peptide-drug conjugate TH1902 for
treatment of all sortilin-expressing cancers. Following our
accomplishments in 2020 and continued expected progress through
2021, we believe we are well-positioned to reach our key business
targets and milestones,” said Paul Lévesque, President and Chief
Executive Officer, Theratechnologies.
Fiscal 2020 Financial
ResultsThe financial results presented in this press
release are taken from the Company’s Management's Discussion and
Analysis, or MD&A, and audited consolidated financial
statements, or Audited Financial Statements, for the twelve-month
period ended November 30, 2020, or Fiscal 2020, which have been
prepared in accordance with International Financial Reporting
Standards, or IFRS, as issued by the International Accounting
Standards Board, or IASB. The MD&A and the Audited Financial
Statements can be found at www.sedar.com, on EDGAR at www.sec.gov
and at www.theratech.com. Unless specified otherwise, all amounts
in this press release are in U.S. dollars and all capitalized terms
have the meaning ascribed thereto in our MD&A.
Revenue for Three-Month and Year ended
November 30, 2020 (in thousands of U.S.
dollars)
|
Three-month ended November 30 |
% change |
Year-ended November 30 |
% change |
|
2020 |
2019 |
|
2020 |
2019 |
|
EGRIFTA®, EGRIFTA SV® net sales |
10,751 |
8,731 |
23.1 |
35,399 |
35,520 |
- |
Trogarzo® net sales |
8,372 |
7,669 |
9.2 |
30,654 |
27,696 |
10.7 |
Revenue |
19,123 |
16,400 |
16.6 |
66,053 |
63,216 |
4.5 |
FY2020 and Recent Business
Highlights
Tesamorelin:
- In August 2020, the Company
completed the transition to EGRIFTA SV® from the original
formulation of EGRIFTA® in the United States.
- In July 2020, the Company completed
the bioequivalence development of the F8 formulation of
tesamorelin, which has a number of advantages over the current
formulation of EGRIFTA SV®. Specifically, it is two times more
concentrated resulting in a smaller volume of administration and is
intended to be presented in a multi-dose vial that can be
reconstituted once per week. The Company is currently working on
the development of a multi-dose pen injector to be used in
conjunction with the F8 formulation and plans to seek marketing
approval of the pen in the same supplemental biologics license
application, or sBLA, as that for the F8 formulation.
Theratechnologies plans to file an sBLA for the F8 formulation and
multi-dose pen injector in early 2022 for the treatment of
lipodystrophy in people living with HIV.
- In September 2020, the Company
announced its intent to develop tesamorelin for the treatment of
NASH in the general population. This decision was largely based on
positive scientific evidence in addition to discussions with
scientific advisors and the FDA and European regulatory agencies
regarding drug development for the treatment of NASH.
- In November 2020, the Company filed
an investigational new drug application, or IND, with the FDA for
the Phase 3 development of tesamorelin for the treatment of adults
with NASH with liver fibrosis.
- In late December 2020, the Company
received a “Study May Proceed” letter for the Phase 3 clinical
trial from the FDA with a recommendation that the Company requests
a meeting to discuss questions and comments provided on certain
aspects of the proposed trial design. Theratechnologies has
formally requested a meeting with the FDA to ensure alignment with
current regulatory expectations for the late-stage development of
treatments for NASH.
- The Company intends to initiate the
Phase 3 clinical trial by the end of the third quarter of calendar
year 2021. The final timing of the trial initiation is dependent
upon any adjustments to the protocol and trial design as
recommended by the FDA and EMA. The Company has retained the
services of a global, large-scale contract research organization,
or CRO, with experience in implementing large and late-stage
clinical trials to assist with the execution of its Phase 3
clinical trial in NASH.
TH1902 for the Treatment of
Sortilin-Expressing Cancers:
- In December 2020, the Company filed
an IND application with the FDA for the Phase 1 first-in-human
development of TH1902, its lead peptide-drug conjugate, or PDC,
(docetaxel conjugate), for the treatment of various cancers. The
proposed Phase 1 clinical trial design includes a dose escalation
study to evaluate the safety, pharmacokinetics, maximum tolerated
dose, or MTD, and preliminary anti-tumor activity of TH1902
administered once every three weeks in patients with advanced solid
tumors refractory to available anti-cancer therapies. Once the MTD
is determined, it is expected that a total of 40 additional
patients will be enrolled to evaluate the potential anti-tumor
activity of TH1902 in patients with endometrial, ovarian,
colorectal, triple-negative breast and pancreatic cancers.
- In January 2021, the Company
received a “Study May Proceed” letter from the FDA for the Phase 1
clinical trial of TH1902. The Phase 1 clinical trial is expected to
be initiated in the second quarter of calendar year 2021 and is
designed to identify a recommended dose for Phase 2
development.
- In February 2021, Theratechnologies
received “Fast Track” designation from the FDA for TH1902 as a
single agent for the treatment of patients with sortilin positive
recurrent advanced solid tumors that are refractory to standard
therapy.
- Preclinical research is ongoing in
melanoma cancer using TH1902. In addition, further preclinical
research activities are being conducted using TH1904, the Company’s
second investigational PDC (doxorubicin conjugate).
Ibalizumab for HIV:
- A study
evaluating an intravenous, or IV, push formulation of Trogarzo® is
currently being conducted by TaiMed. Enrollment in this study is
now complete and TaiMed expects to complete the trial in the third
quarter of 2021. Theratechnologies and TaiMed are also planning to
evaluate an intramuscular, or IM, method of administration of
Trogarzo®. Enrollment for the IM study is expected to begin in the
first half of 2021. Under the terms of the TaiMed Agreement, we are
entitled to commercialize the new methods of administration of
Trogarzo® if, and when, approved.
- In connection
with the September 2019 approval of Trogarzo® in Europe, the EMA
has requested a post-authorization efficacy study, or Registry, to
be conducted to evaluate the long-term efficacy and durability of
Trogarzo® in combination with other antiretrovirals. The enrollment
of patients in this study is expected to begin in late 2021. The
Company is also required to conduct a pediatric investigation plan,
or PIP, to evaluate Trogarzo® in children aged 6 to <18 years
old. The PIP will be comprised of two studies with the first study
expected to begin in the second half of 2021.
Fiscal 2020 Financial
ResultsConsolidated revenue for Fiscal 2020 was
$66,053,000 compared to $63,216,000 for the same period last year,
representing an increase of 4.5%.
For Fiscal 2020, sales of EGRIFTA® and EGRIFTA
SV® reached $35,399,000 compared to $35,520,000 for the same period
last year.
In Fiscal 2020, Trogarzo® sales were $30,654,000
compared to $27,696,000 for the same period last year, representing
an increase of 10.7%.
Cost of SalesFor Fiscal 2020,
cost of sales was $26,902,000 compared to $26,076,000 in the
comparable period of Fiscal 2019. Cost of sales included cost of
goods sold that amounted to $20,970,000 in Fiscal 2020 compared to
$21,125,000 in Fiscal 2019. The decrease in cost of goods sold was
mainly due to lower cost of goods for EGRIFTA SV® compared to
EGRIFTA® and a lower transfer price for Trogarzo® in the fourth
quarter of Fiscal 2020 given the achievement of a predetermined
amount of net sales of the product on the U.S. market.
R&D ExpensesR&D
expenses were $18,019,000 for Fiscal 2020 compared to $10,841,000
for Fiscal 2019. The increase in R&D expenses was largely due
to the development of our oncology platform, the F8 Formulation and
multi-dose pen injector, spending related to the development of
tesamorelin for the treatment of NASH in the general population as
well as regulatory expenses and increased medical education
initiatives in Europe in preparation for the Trogarzo® launch.
Selling ExpensesSelling
expenses for Fiscal 2020 were $26,859,000 compared to $26,482,000
for the same period in Fiscal 2019.
General and Administrative
ExpensesGeneral and administrative expenses for Fiscal
2020 were $12,230,000 compared to $8,330,000 for the same period in
Fiscal 2019. The increase over the same period last year was
due to the transition to a new President and Chief Executive
Officer, additional expenses incurred in Fiscal 2020 as a result of
the listing of our common shares on the NASDAQ and a ramp up of
administrative activities in Europe in preparation for the
Trogarzo® launch.
Finance IncomeFinance income, consisting of
interest income, for Fiscal 2020 was $299,000 compared to
$1,097,000 in Fiscal 2019. Lower finance income during Fiscal
year 2020 was primarily related to a lower average liquidity
position.
Finance CostsFinance costs for
Fiscal 2020 were $4,993,000 compared to $5,080,000 in
Fiscal 2019. Finance costs in Fiscal 2020 mostly
represented interest of $3,306,000 on the 5.75% convertible
unsecured senior notes, issued on June 19, 2018, or Notes, compared
to $3,317,000 in Fiscal 2019.
Finance costs also included an accretion
expense, which amounted to $2,056,000 during Fiscal 2020 compared
to $1,673,000 during Fiscal 2019.
Adjusted EBITDAAdjusted EBITDA
for Fiscal 2020 was $(7,093,000) compared to $323,000 in
Fiscal 2019, reflecting increased investments towards building
our infrastructure in Europe, increased R&D expenses and higher
general and administrative expenses. These higher expenses were
partially offset by higher revenues related to growing Trogarzo®
sales. See “Non-IFRS Financial Measures” below.
Net lossTaking into account the
revenue and expense variations described above, we recorded a net
loss of $22,667,000, or $0.29 per share, in Fiscal 2020 compared to
$12,496,000, or $0.16 per share, in Fiscal 2019.
Fourth-Quarter Fiscal 2020 Financial
Results
Consolidated revenue for the three months ended
November 30, 2020 amounted to $19,123,000 compared to
$16,400,000 for the same period last year, representing an increase
of 16.6%.
For the fourth quarter of Fiscal 2020,
sales of EGRIFTA SV® reached $10,751,000 compared to $8,731,000 in
the fourth quarter of the prior year, representing an increase of
23.1%.
In the fourth quarter of Fiscal 2020, Trogarzo®
sales amounted to $8,372,000 compared to $7,669,000 for the same
quarter of 2019, representing an increase of 9.2%.
Cost of SalesFor the
three-month period ended November 30, 2020, cost of sales
was $6,650,000 compared to $6,989,000 in the comparable period of
Fiscal 2019. Cost of goods sold was $5,190,000 compared to
$5,754,000 for the same period last year. The decrease in cost of
goods sold was mainly due to lower cost of goods for EGRIFTA SV®
compared to EGRIFTA® and a lower transfer price for Trogarzo® given
the achievement of a predetermined of net sales of the product on
the U.S. market.
Cost of sales included an amortization of
$1,220,000 in the fourth quarter of 2020 and 2019 in connection
with the settlement of the future royalty obligation which has been
accounted as “Other asset” on the consolidated statement of the
financial position.
R&D ExpensesR&D
expenses in the three-month period ended
November 30, 2020 amounted to $6,795,000 compared to
$3,877,000 in the comparable period of Fiscal 2019. The
increase during the fourth quarter of Fiscal 2020 was largely due
to the development of our oncology platform, the F8 Formulation and
multi-dose pen injector, and spending related to the development of
tesamorelin for the treatment of NASH in the general population as
well as regulatory expenses and increased medical education
initiatives in Europe in preparation for the Trogarzo® launch.
Selling ExpensesSelling
expenses in the three-month period ended
November 30, 2020 amounted to $6,532,000 compared to
$7,673,000 in the comparable period of Fiscal 2019.
The decrease in selling expenses is largely
associated with lower spending in Europe given a shift to spending
related to medical affairs, lower Trogarzo® promotion spending as
well as lower headcount in our field sales force.
The amortization of the intangible asset value
established for the EGRIFTA®, EGRIFTA SV® and Trogarzo®
commercialization rights in North America was also included in
selling expenses. We recorded an expense of $795,000 in the fourth
quarter of Fiscal 2020 compared to $642,000 for the same period of
Fiscal 2019.
General and Administrative
ExpensesGeneral and administrative expenses in the fourth
quarter of Fiscal 2020 amounted to $3,255,000, which was relatively
in line with $3,258,000 reported in the same period of
Fiscal 2019.
Finance IncomeFinance income,
consisting of interest income, for the three-month period ended
November 30, 2020 was $21,000 compared to $217,000 in the
comparable quarter of Fiscal 2019. Lower finance income was a
reflection of our lower liquidity position during the fourth
quarter of Fiscal 2020 compared to the same period of Fiscal
2019.
Finance CostsFinance costs for
the fourth quarter of Fiscal 2020 were $1,445,000 compared to
$1,275,000 for the same quarter of Fiscal 2019. As previously
stated, finance costs are mostly comprised of interest on the
Notes.
Finance costs also included accretion expense,
which was $548,000 for the fourth quarter of Fiscal 2020 compared
to $440,000 for the same period last year. Accretion expense was
mainly associated with the Notes.
Adjusted EBITDAAdjusted EBITDA
for the fourth quarter of Fiscal 2020 was $(1,417,000) compared to
$(3,217,000) in same period of Fiscal 2019. See “Non-IFRS
Financial Measures” below.
The variation from Q4 2019 to Q4 2020
was mainly due to higher net sales, higher gross margins and lower
selling expenses, which was offset by higher spending on research
and development activities in the fourth quarter of 2020.
Net lossTaking into account the
revenue and expense variations described above, we recorded a net
loss of $5,549,000, or $0.07 per share, in the fourth quarter of
Fiscal 2020 compared to a net loss of $6,445,000, or $0.08 per
share, in the fourth quarter of Fiscal 2019.
Financial PositionWe ended the
fourth quarter of Fiscal 2020 with $20,768,000 in cash, bonds and
money market funds.
For the three-month period ended
November 30, 2020, operating activities used $5,906,000
compared to generating $2,760,000 in the comparable period of
Fiscal 2019.
In the fourth quarter of Fiscal 2020,
changes in operating assets and liabilities had a negative impact
on cash flow of $4,402,000. These changes included an increase of
$4,149,000 in accounts receivable, an increase in prepaid expenses
of $2,739,000, which were offset by an increase in accounts payable
of $3,210,000. These changes are related to an increase in our
commercial activities.
Quarterly Financial
Information
The following table is a summary of our
unaudited consolidated operating results for the three-month
periods ended November 30, 2020 and November 30, 2019
(In thousands of
dollars, except per share amounts)
|
20201 |
|
2019 |
|
|
Q4 |
Q3 |
Q2 |
Q1 |
Q4 |
Q3 |
Q2 |
Q1 |
Revenue |
19,123 |
|
14,049 |
|
17,162 |
|
15,719 |
|
16,400 |
|
16,111 |
|
15,609 |
|
15,096 |
|
Operating expenses |
|
|
|
|
|
|
|
|
Cost of sales |
|
|
|
|
|
|
|
|
Cost of goods sold |
5,190 |
|
4,611 |
|
5,769 |
|
5,400 |
|
5,754 |
|
5,215 |
|
5,346 |
|
4,810 |
|
Other production-related costs |
240 |
|
280 |
|
391 |
|
140 |
|
14 |
|
1 |
|
18 |
|
34 |
|
Amortization of other asset |
1,220 |
|
1,220 |
|
1,220 |
|
1,221 |
|
1,221 |
|
1,221 |
|
1,221 |
|
1,221 |
|
R&D |
6,795 |
|
4,183 |
|
3,622 |
|
3,419 |
|
3,877 |
|
2,152 |
|
2,285 |
|
2,527 |
|
Selling |
6,532 |
|
7,025 |
|
6,941 |
|
6,361 |
|
7,673 |
|
6,389 |
|
6,972 |
|
5,448 |
|
General and administrative |
3,255 |
|
2,699 |
|
3,706 |
|
2,570 |
|
3,258 |
|
1,772 |
|
1,784 |
|
1,516 |
|
Total operating expenses |
23,232 |
|
20,018 |
|
21,649 |
|
19,111 |
|
21,797 |
|
16,750 |
|
17,626 |
|
15,556 |
|
Finance income |
21 |
|
32 |
|
80 |
|
166 |
|
217 |
|
253 |
|
292 |
|
335 |
|
Finance costs |
(1,445 |
) |
(831 |
) |
(1,399 |
) |
(1,318 |
) |
(1,275 |
) |
(1,253 |
) |
(1,449 |
) |
(1,103 |
) |
Net (loss) profit |
(5,549 |
) |
(6,768 |
) |
(5,806 |
) |
(4,544 |
) |
(6,455 |
) |
(1,639 |
) |
(3,174 |
) |
(1,228 |
) |
Basic and diluted (loss) earnings per share |
(0.07 |
) |
(0.09 |
) |
(0.08 |
) |
(0.06 |
) |
(0.08 |
) |
(0.02 |
) |
(0.04 |
) |
(0.02 |
) |
1 |
The Company
adopted IFRS 16 – Leases, using the modified retrospective
approach, effective for Fiscal 2020, beginning on December 1, 2019.
Accordingly, comparative figures for Fiscal 2019 and Fiscal 2018
have not been restated and continue to be reported under IAS 17–.
See note 1 in the Audited Financial Statements. |
Subsequent eventOn January 19,
2021, the Company completed a public offering for the sale and
issuance of 16,727,900 units of the Company for a gross cash
consideration of $46,002,000 including the full exercise of the
over-allotment option. Share issue costs are estimated at
$3,334,000 resulting in net proceeds of $42,668,000.
Each unit is comprised
of one common share of the Company and one-half of one common share
purchase warrant of the Company (each whole warrant, a “Warrant”).
Each Warrant entitles the holder to purchase one common share of
the Company at an exercise price of $3.18 until January 19,
2024.
Our current cash, bond
and money market funds will be sufficient to fund the Company’s
operations for at least the next twelve months from the balance
sheet date.
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 profit (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 for the stock option plan, lease
inducements prior to the adoption of IFRS-16, 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
U.S. dollars)
|
Three-month periodsended November 30, |
Year ended November
30, |
|
20201 |
|
2019 |
|
20201 |
|
2019 |
|
|
$ |
|
$ |
|
$ |
|
$ |
|
Net loss |
(5,549 |
) |
(6,455 |
) |
(22,667 |
) |
(12,496 |
) |
Add (deduct): |
|
|
|
|
Depreciation and
amortization |
2,192 |
|
1,930 |
|
8,520 |
|
7,495 |
|
Lease inducements and
amortization |
0 |
|
5 |
|
0 |
|
238 |
|
Finance costs |
1,445 |
|
1,275 |
|
4,993 |
|
5,080 |
|
Finance income |
(21 |
) |
(217 |
) |
(299 |
) |
(1,097 |
) |
Income
taxes |
16 |
|
- |
|
16 |
|
- |
|
Share-based
compensation |
259 |
|
232 |
|
1,427 |
|
1,087 |
|
Write-down of inventories |
241 |
|
13 |
|
917 |
|
16 |
|
Adjusted EBITDA |
(1,417 |
) |
(3,217 |
) |
(7,093 |
) |
323 |
|
1 |
The Company
adopted IFRS-16 – Leases, using the modified retrospective
approach, effective for Fiscal 2020, beginning on December 1, 2019.
Accordingly, comparative figures for Fiscal 2019 have not been
restated. As a result, adjusted EBITDA includes adjustments for
additional amortization related to the right-of-use asset of
$112,000 and an accretion expense on lease liabilities, included in
finance costs, of $53,000 for the three-months ended November 30,
2020. In addition, adjusted EBITDA includes adjustments for
additional amortization related to the right-to-use asset of
$441,000 for the year ended November 30, 2020. |
Conference Call DetailsA
conference call and webcast will be held on February 25, 2020 at
8:30 a.m. (ET) to discuss the results. The call will be hosted by
Paul Lévesque, President and Chief Executive Officer of
Theratechnologies, and other members of the management team.
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 at
https://edge.media-server.com/mmc/p/2ndpjwpm. Audio replay of the
conference call will be available on the same day starting at 12:00
p.m. (ET) until March 04, 2021, by dialing 1-855-859-2056 (North
America) or 1-404-537-3406 (International) and by entering the
access code: 8274898. The audio replay will be available on
https://edge.media-server.com/mmc/p/2ndpjwpm.
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.sedar.com and on
EDGAR at www.sec.gov
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",
“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 achievements of our objectives in 2021, the timelines
to begin our clinical trials, the PIP and the enrollment of
patients for the Registry, the development of the F8 Formulation,
the multi-dose pen injector and an IM method of administration of
Trogarzo®, and the timelines to file a sBLA for the F8 Formulation
and the multi-dose pen injector.
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 the United States
will increase over time; the Company’s commercial practices in the
United States and the countries of the European Union will not be
found to be in violation of applicable laws; the long-term use of
EGRIFTA SV® and Trogarzo® will not change their respective current
safety profile; no recall or market withdrawal of EGRIFTA SV® and
Trogarzo® will occur; no laws, regulation, order, decree or
judgment will be passed or issued by a governmental body negatively
affecting the marketing, promotion or sale of EGRIFTA SV® and
Trogarzo® in countries where such products are commercialized;
continuous supply of EGRIFTA SV® and Trogarzo® will be available;
the Company’s relations with third-party suppliers of EGRIFTA SV®
and Trogarzo® will be conflict-free and such third-party suppliers
will have the capacity to manufacture and supply EGRIFTA SV® and
Trogarzo® to meet market demand on a timely basis; no biosimilar
version of EGRIFTA SV® will be approved by the FDA; the Company’s
intellectual property will prevent companies from commercializing
biosimilar versions of EGRIFTA SV® in the United States; Trogarzo®
will be reimbursed in key European countries; the FDA will approve
the F8 formulation and the multi-dose pen injector; the FDA and the
European regulatory agencies will approve a common design for the
Phase 3 clinical trial studying tesamorelin for the treatment
of NASH in the general population; the Company will succeed in
conducting such Phase 3 clinical trial and its Phase 1
clinical trial using TH1902 in various types of cancer; the
Company’s research and development activities using peptides
derived from its oncology platform will yield positive results
allowing for the development of new drugs for the treatment of
cancer; the Company’s European infrastructure is adequate to
commercialize Trogarzo® in Germany and in other European countries;
and the Company’s business plan will not be substantially
modified.
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 the United States and Trogarzo® in Europe; the
Company’s capacity to meet supply and demand for its products; the
market acceptance of EGRIFTA SV® and Trogarzo® in the United States
and of Trogarzo® in Europe; 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; the
Company’s success in continuing to seek and maintain reimbursements
for EGRIFTA SV® and Trogarzo® by third-party payors in the United
States; the success and pricing of other competing drugs or
therapies that are or may become available in the marketplace; the
Company’s ability to protect and maintain its intellectual property
rights in EGRIFTA SV® and tesamorelin; the Company’s success in
obtaining reimbursement for Trogarzo® in key European countries,
together with the level of reimbursement, if at all; the Company’s
ability and capacity to commercialize Trogarzo® in Germany and to
launch Trogarzo® in other key countries of the European Union; the
Company’s ability to obtain the approval by the FDA of the F8
Formulation and the multi-dose pen injector; the Company’s ability
to obtain an agreement with the FDA for its Phase 3 clinical
trial design studying tesamorelin in the NASH general population;
the Company’s ability to successfully conduct its Phase 3
clinical trial using tesamorelin for the treatment of NASH in the
general population and its Phase 1 clinical trial using TH1902 in
various types of cancer and delays that may occur in the timelines
to complete such trials; the Company’s capacity to acquire or
in-license new products and/or compounds; the Company’s
expectations regarding its financial performance, including
revenues, expenses, gross margins, profitability, liquidity,
capital expenditures and income taxes; and the Company’s estimates
regarding its capital requirements.
We refer current and
potential investors to the “Risk Factors” section of our Annual
Information Form dated February 24, 2021 available on SEDAR at
www.sedar.com and on EDGAR at www.sec.gov as an exhibit to our
report on Form 40-F dated February 25, 2021 under
Theratechnologies’ public filings. 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.
For media inquiries:Denis BoucherVice President, Communications
and Corporate Affairscommunications@theratech.com514-336-7800
For investor inquiries:Leah GibsonSenior Director, Investor
Relationslgibson@theratech.com617-356-1009
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