- Enters into Letter of Intent (LOI) that paves the way for
product listing agreements for Vascepa with all of Canada's provinces and territories.
- Public market access is expected to be a significant
catalyst to bring Vascepa to Canadians who are at-risk for
cardiovascular disease.
- HLS updates its peak-year sales estimate to $250-300 million in revenue with Adjusted EBITDA
margin of approximately 30%. Peak-year estimates expected to be
reached in 2026.
- Conference call to be held today at 8:30am ET to discuss this announcement
TORONTO, April 26,
2022 /CNW/ - HLS Therapeutics Inc. ("HLS" or the
"Company") (TSX: HLS), a pharmaceutical company focusing on central
nervous system ("CNS") and cardiovascular markets, announces that
it has completed a Letter of Intent ("LOI") with the pan-Canadian
Pharmaceutical Alliance ("pCPA") for the terms and conditions under
which Vascepa would qualify for public market reimbursement in
Canada. All financial figures are
in Canadian dollars.
"We are very pleased to have completed the negotiation process
with the pCPA. This LOI is a significant milestone for making
Vascepa available to Canadians who are at-risk for cardiovascular
disease and who are a part of one of the country's public payer
plans," said Gilbert Godin, CEO of
HLS. "The LOI sets out the terms for reimbursement of Vascepa for
statin-treated patients with established cardiovascular diseases
and elevated triglycerides, which follows on the patient-population
recommendation issued previously by the Canadian Agency for Drugs
and Technologies in Health (CADTH)."
"We now look forward to working diligently with all
participating jurisdictions to secure coverage from publicly funded
drug plans across Canada, and for
Vascepa to be added to their respective plans. Based on recent
examples, we believe that Vascepa will be progressively added to
provincial and territorial formularies over the next few
months."
"Having already achieved reimbursement for more than 90% of
private payer in-label patients, inclusion of Vascepa in the
guidelines from Canada's leading
organizations in the field of Cardiovascular health and expansion
of our salesforce through an agreement with Pfizer, we believe that
the public market access we are announcing today will galvanize and
strengthen the impact of these prior accomplishments and that it
positions the Company for transformational growth."
PEAK-YEAR SALES OUTLOOK
With greater visibility now available regarding public
reimbursement, HLS is updating its peak-year sales estimate. The
Company now estimates peak-year sales for Vascepa of between
$250-300 million, along with Adjusted
EBITDA1 margins of approximately 30%, compared to prior
estimates of $275-325 million in
sales and an Adjusted EBITDA margin of 35-40%. As COVID-19-related
restrictions are being lifted across Canada, HLS now expects to reach its peak-year
estimates in 2026 due to the cumulative effect and delays of the
pandemic to-date.
Mr. Godin added: "The details of the LOI and the product listing
agreements that are to follow are confidential. However, based on
Vascepa's favorable feedback from physicians and patients, healthy
prescribing and adoption rates, the early results from the Pfizer
collaboration and favorable longer term competitive developments,
we are confident that the negotiations to achieve broad public
market access will be largely compensated for by a higher
penetration rate than previously estimated."
"We believe this is a very positive outcome for patients and
physicians looking to gain access to this life-saving medication,
as well as for HLS as it provides the potential for a nearly
four-fold increase in the Company's revenue and Adjusted EBITDA
over a five-year time horizon."
CONFERENCE CALL &
WEBCAST
HLS will hold a conference call today at 8:30 am Eastern Time to discuss this
announcement. The call will be hosted by Mr. Gilbert Godin, Chief Executive Officer and Mr.
Tim Hendrickson, Chief Financial
Officer.
CONFERENCE
ID:
|
17250252
|
DATE:
|
April 26,
2022
|
TIME:
|
8:30 a.m. ET
|
DIAL-IN
NUMBER:
|
1-888-664-6392 or
416-764-8659
|
WEBCAST
LINK:
|
https://produceredition.webcasts.com/starthere.jsp?ei=1546132&tp_key=e413a7d87b
|
TAPED
REPLAY:
|
1-888-390-0541 or
416-764-8677
|
REPLAY
CODE:
|
250252
|
The taped replay will be available for 14 days and the archived
webcast will be available for 90 days.
A link to the live audio webcast of the conference call will
also be available on the events page of the investors section of
HLS Therapeutics' website at www.hlstherapeutics.com. Please
connect at least 15 minutes prior to the conference call to ensure
adequate time for any software download that may be required to
hear the webcast.
ABOUT HLS THERAPEUTICS
INC.
Formed in 2015, HLS is a pharmaceutical company focused on the
acquisition and commercialization of late-stage development,
commercial stage promoted and established branded pharmaceutical
products in the North American markets. HLS's focus is on products
targeting the central nervous system and cardiovascular therapeutic
areas. HLS's management team is composed of seasoned pharmaceutical
executives with a strong track record of success in these
therapeutic areas and at managing products in each of these
lifecycle stages. For more information visit:
www.hlstherapeutics.com
1CAUTIONARY NOTE
REGARDING NON-IFRS MEASURES
This press release refers to certain non-IFRS measures. These
measures are not recognized measures under IFRS, do not have a
standardized meaning prescribed by IFRS and are therefore unlikely
to be comparable to similar measures presented by other companies.
Rather, these measures are provided as additional information to
complement those IFRS measures by providing further understanding
of HLS's results of operations from management's perspective.
Accordingly, they should not be considered in isolation nor as a
substitute for analysis of HLS's financial information reported
under IFRS. HLS uses non-IFRS measures to provide investors with
supplemental measures of its operating performance and thus
highlight trends in its core business that may not otherwise be
apparent when relying solely on IFRS financial measures. HLS also
believes that securities analysts, investors and other interested
parties frequently use non-IFRS measures in the evaluation of
issuers. HLS's management also uses non-IFRS measures in order to
facilitate operating performance comparisons from period to period,
prepare annual operating budgets and assess HLS's ability to meet
its future debt service, capital expenditure and working capital
requirements.
In particular, management uses Adjusted EBITDA as a
measure of HLS's performance. To reconcile net income (loss)
for the period with Adjusted EBITDA, each of (i) "stock-based
compensation", (ii) "amortization and depreciation", (iii)
"acquisition and transaction costs", (iv) "finance and related
costs", and (v) "income tax expense (recovery)" appearing in the
Consolidated Statement of Net Income (Loss) are added to net income
(loss) for the period to determine Adjusted EBITDA. Adjusted EBITDA
does not have any standardized meaning prescribed by IFRS and is
not necessarily comparable to similar measures presented by other
companies. Adjusted EBITDA should not be considered in
isolation or as a substitute for net income (loss) prepared in
accordance with IFRS as issued by the IASB.
FORWARD LOOKING
INFORMATION
This release includes forward-looking statements regarding
HLS and its business. Such statements are based on the current
expectations and views of future events of HLS's management. In
some cases the forward-looking statements can be identified by
words or phrases such as "may", "will", "expect", "plan",
"anticipate", "intend", "potential", "estimate", "believe" or the
negative of these terms, or other similar expressions intended to
identify forward-looking statements, including, among others,
statements with respect to HLS's pursuit of additional product and
pipeline opportunities in certain therapeutic markets, statements
regarding growth opportunities, expectations regarding financial
performance, and the NCIB and ASPP. The forward-looking events and
circumstances discussed in this release may not occur and could
differ materially as a result of known and unknown risk factors and
uncertainties affecting HLS, including risks relating to the
specialty pharmaceutical industry, risks related to the regulatory
approval process, economic factors and many other factors beyond
the control of HLS. Forward-looking statements and information by
their nature are based on assumptions and involve known and unknown
risks, uncertainties and other factors which may cause HLS's actual
results, performance or achievements, or industry results, to be
materially different from any future results, performance or
achievements expressed or implied by such forward-looking statement
or information. Accordingly, readers should not place undue
reliance on any forward-looking statements or information. A
discussion of the material risks and assumptions associated with
this release can be found in the Company's Annual Information Form
dated March 16, 2022, and
Management's Discussion and Analysis dated March 16, 2022,
both of which have been filed on SEDAR and can be accessed at
www.sedar.com. Accordingly, readers should not place undue reliance
on any forward-looking statements or information. Except as
required by applicable securities laws, forward-looking statements
speak only as of the date on which they are made and HLS undertakes
no obligation to publicly update or revise any forward-looking
statement, whether as a result of new information, future events,
or otherwise.
SOURCE HLS Therapeutics Inc.