- Q3 2020 Adjusted Total Revenue -
$16.7 million -
- Q3 2020 Adjusted EBITDA - $6.6
million -
- Blexten Canadian Prescriptions Increased 30% Year-Over-Year -
- Cambia Canadian Prescriptions Increased 13% Year-Over-Year
-
Nuvo to Host Conference Call/Audio
Webcast November 16 at 8:30 a.m. ET
MISSISSAUGA, ON, Nov. 16, 2020 /CNW/ - Nuvo Pharmaceuticals Inc.
(Nuvo or the Company) (TSX: NRI) (OTCQX: NRIFF), a Canadian
focused, healthcare company with global reach and a diversified
portfolio of commercial products, today announced its financial and
operational results for the three and nine months ended
September 30, 2020. For further
details on the results, please refer to Nuvo's Management,
Discussion and Analysis (MD&A) and Condensed Consolidated
Interim Financial Statements for the three and nine months ended
September 30, 2020 which are
available on the Company's website
(www.nuvopharmaceuticals.com). All figures are in Canadian
dollars, unless otherwise noted.
Key Developments
Three months ended September 30, 2020 include the following:
- Adjusted total revenue(1) was $16.7 million, a decrease of 12% compared to
$18.9 million for the three months
ended September 30, 2019.
- Adjusted EBITDA(1) was $6.6
million, a decrease of 15% compared to $7.8 million for the three months ended
September 30, 2019.
- The Company's Commercial Business segment includes the promoted
products - Blexten® and Cambia ®.
Revenue related to these products was $6.4
million, an increase of 21% compared to revenue of
$5.3 million for the three months
ended September 30, 2019.
Canadian prescriptions of Blexten and Cambia increased by 30% and
13%, respectively compared to the three months ended September 30, 2019.
- Principal loan repayments of $3.7
million (US$2.8 million).
Nine months ended September 30,
2020 include the following:
- Adjusted total revenue(1) was $53.6 million, a decrease of 3% compared to
$55.1 million for the nine months
ended September 30, 2019.
- Adjusted EBITDA(1) was $22.2
million, an increase of 19% compared to $18.7 million for the nine months ended
September 30, 2019.
- Revenue related to Blexten and Cambia was $18.7 million, an increase of 34% compared to
revenue of $13.9 million for the nine
months ended September 30,
2019. Canadian prescriptions of Blexten and Cambia increased
by 37% and 13%, respectively compared to the nine months ended
September 30, 2019.
- Principal loan repayments of $18.8
million (US$14.0
million).
(1)
|
Non-International
Financial Reporting Standards (IFRS) financial measure defined by
the Company below.
|
Business Update
- As a result of the COVID-19 pandemic, the Company has made
changes to operations to ensure our employees are safe and healthy,
while the business continues to supply global partners,
wholesalers, pharmacies, and ultimately patients, with our
healthcare products. The Commercial Business segment had continued
organic growth of its key promoted products - Blexten and Cambia.
The possibility of future supply disruptions resulted in forward
buying linked to the COVID-19 pandemic which increased revenue in
the three months ended March 31, 2020
and reduced revenue in the three months ended June 30, 2020 as the pandemic progressed. Buying
patterns stabilized in the three months ended September 30, 2020. It is anticipated that the
COVID-19 pandemic may continue to impact the timing of revenue in
future quarters and the Company will monitor market dynamics
accordingly.
- In September 2020, Aralez
Pharmaceuticals Canada, Inc. (Aralez Canada) received notice that
Health Canada had issued a medical device license for two new line
extensions of NeoVisc®. NeoVisc is a viscosupplement
used to replenish the synovial fluid in the joints of patients with
osteoarthritis. NeoVisc One contains the lowest injection volume
(only 4ml) available for single-dose viscosupplements in
Canada. Neovisc Plus consists of a
three injection dosing system that is administered to a patient
over the course of a few weeks. In some patients, a three dose
treatment may provide longer relief.
- In September 2020, Aralez Canada
launched Suvexx® into the approximately $130 million Canadian prescription acute migraine
market. Suvexx (sumatriptan succinate and naproxen sodium tablets)
is a fixed-dose combination prescription medication, indicated for
the acute treatment of migraine attacks with or without aura in
adults. Suvexx helps patients manage acute migraine attacks using a
combination of sumatriptan succinate and naproxen sodium in a
single tablet.
- In August 2020, the Blexten
pediatric dossier was accepted for review by Health Canada. If
approved, Blexten pediatric will be available in both an oral syrup
formulation (2.5mg/ml) and an orally dispersible tablet formulation
(10mg tablets). A regulatory decision from Health Canada is
anticipated by mid-2021.
- During the three months ended September
30, 2020, the Company made a $3.7
million (US$2.8 million)
principal repayment on the Amortization Loan, included within the
loans held by Deerfield Management Company, L.P and its related
entities (the Deerfield Loans). Since January 1, 2020, the Company has repaid
$18.8 million (US$14.0 million) of the Deerfield Loans -
$4.5 million (US$3.5 million) to discharge the Bridge Loan
which bore interest at 12.5% and $14.2
million (US$10.5 million)
against the Amortization Loan which bears interest at 3.5%. As of
September 30, 2020, the total
remaining balances of the Deerfield Loans consisted of:
US$49.5 million on the Amortization
Loan and US$52.5 million on the
Convertible Loan both of which bear interest at 3.5%.
"In September, we launched our innovative treatment for acute
migraine attacks, Suvexx, into the Canadian market. Thus far,
the Suvexx launch has been well received with encouraging feedback
from physicians and patients who now have access to this new
medicine. Despite the COVID-19 pandemic, our key promoted
products, Blexten and Cambia, have continued to grow both in terms
of total prescriptions and market share versus 2019. The loss
of the guaranteed minimum royalty for Vimovo in the U.S. has
negatively impacted our top-line sales revenue; however, the
restructuring we implemented in Q2 2019 has helped to improve both
our adjusted EBITDA and cash from operating activities during the
quarter and year-to-date," said Jesse Ledger, Nuvo's President
& CEO. "In Q3, we made continued progress in repaying our
debt to Deerfield and have now
repaid over $18 million
year-to-date. We continue to meet our growth strategy
objectives and look forward to a strong finish to the year."
Third Quarter 2020 Financial Results
Total
revenue is comprised of product sales, license revenue and contract
revenue. Total revenue was $16.6
million and $56.5 million for
the three and nine months ended September
30, 2020 compared to $18.8
million and $50.0 million for
the three and nine months ended September
30, 2019.
Adjusted total revenue was $16.7 million and $53.6 million for the three and nine months ended
September 30, 2020 compared to
$18.9 million and $55.1 million for the three and nine months ended
September 30, 2019. The
$2.2 million decrease in adjusted
total revenue in the current quarter was primarily attributable to
a decrease of $1.6 million of revenue
in the Licensing and Royalty Business segment, combined with a
decrease of $0.4 million of revenue
in the Production and Service Business segment and a $0.1 million decrease in revenue from the
Commercial Business segment. The Commercial Business segment
revenue had continued organic growth of its key promoted products -
Blexten and Cambia. The possibility of future supply
disruptions resulted in forward buying linked to the COVID-19
pandemic which increased revenue in the three months ended
March 31, 2020 and reduced revenue in
the three months ended June 30, 2020
and stabilized in the three months ended September 30, 2020 as the pandemic progressed and
buying patterns returned to normal. The COVID-19 pandemic may
impact the timing of revenue in future quarters and the Company
will continue to monitor market dynamics accordingly. For the
three months ended September 30,
2020, the Licensing and Royalty Business segment revenue
decreased primarily due to a reduction in both U.S. and rest of
world net sales of Vimovo. The Production and Service Business
segment revenue decreased as a result of a decrease in the
Company's Pennsaid product sales.
Adjusted EBITDA was $6.6 million
and $22.2 million for the three and
nine months ended September 30, 2020
compared to $7.8 million and
$18.7 million for the three and nine
months ended September 30,
2019. The decrease in the current quarter was primarily
attributable to the decrease in gross profit of $2.4 (net of revenue recognized upon recognition
of contract assets, amounts billed to customers for existing
contract assets and inventory-step up expenses, partially offset by
a decrease in general and administrative (G&A) expenses (net of
amortization). This decline in gross profit was due to a
decrease in adjusted total revenue, partially offset by an increase
in gross margin percentage on product sales due to the receipt of
the Canada Emergency Wage Subsidy,
as well as changes in product mix.
Gross profit on total revenue was $10.2
million or 61% and $39.1
million or 69% for the three and nine months ended
September 30, 2020 compared to a
gross profit of $11.3 million or 60%
and $30.0 million or 60% for the
three and nine months ended September
30, 2019. The decrease in gross profit for the current
three was primarily attributable to a decrease in license revenue,
partially offset by an increase in gross margin on product sales
(See Total Revenue above). The increase in gross
profit for the current nine-month period was primarily attributable
to an increase in license revenue and gross margin on product sales
(See Total Revenue above).
Non-IFRS Financial Measures
The Company discloses
non-IFRS measures (such as adjusted total revenue, adjusted EBITDA
and adjusted EBITDA per share) that do not have standardized
meanings prescribed by IFRS. The Company believes that
shareholders, investment analysts and other readers find such
measures helpful in understanding the Company's financial
performance and in interpreting the effect of the Aralez
Transaction and the Deerfield Financing on the Company.
Non-IFRS financial measures do not have any standardized meaning
prescribed by IFRS and may not have been calculated in the same way
as similarly named financial measures presented by other
companies.
The following is a summary of how adjusted total revenue is
calculated:
|
Three months
ended
September 30
|
Nine months ended
September 30
|
|
2020
|
2019
|
2020
|
2019
|
in
thousands
|
$
|
$
|
$
|
$
|
Total
revenue
|
16,601
|
18,823
|
56,492
|
49,953
|
Add:
|
|
|
|
|
Amounts billed to
customers for existing contract assets
|
68
|
66
|
2,632
|
5,127
|
Deduct:
|
|
|
|
|
Revenue recognized
upon recognition of a contract asset
|
-
|
-
|
(5,496)
|
-
|
Adjusted total
revenue
|
16,669
|
18,889
|
53,628
|
55,080
|
Adjusted EBITDA
EBITDA refers to net income (loss)
determined in accordance with IFRS, before depreciation and
amortization, net interest expense (income) and income tax expense
(recovery). The Company defines adjusted EBITDA as net income
before net interest expense (income), depreciation and amortization
and income tax expense (recovery) (EBITDA), plus amounts billed to
customers for existing contract assets, inventory step-up expenses,
stock-based compensation expense, Other Expenses (Income), less
revenue recognized upon recognition of a contract asset and other
income. Managexment believes adjusted EBITDA is a useful
supplemental measure to determine the Company's ability to generate
cash available for working capital, capital expenditures, debt
repayments, interest expense and income taxes.
The following is a summary of how EBITDA and adjusted EBITDA are
calculated:
|
Three months
ended
September 30
|
Nine months ended
September 30
|
|
2020
|
2019
|
2020
|
2019
|
in
thousands
|
$
|
$
|
$
|
$
|
Net income
(loss)
|
(2,832)
|
4,425
|
(6,528)
|
3,817
|
Add back:
|
|
|
|
|
Income tax expense
(recovery)
|
(7)
|
(151)
|
1,587
|
(1)
|
Net interest
expense
|
2,904
|
3,166
|
9,019
|
7,163
|
Depreciation and
amortization
|
2,250
|
2,349
|
6,965
|
7,234
|
EBITDA
|
2,315
|
9,789
|
11,043
|
18,213
|
Add back:
|
|
|
|
|
Amounts billed to
customers for existing contract assets
|
68
|
66
|
2,632
|
5,127
|
Stock-based
compensation
|
50
|
112
|
208
|
343
|
Deduct:
|
|
|
|
|
Revenue recognized
upon recognition of a contract asset
|
-
|
-
|
(5,496)
|
-
|
Other Expenses
(Income):
|
|
|
|
|
Change in fair value
of derivative liabilities(1)
|
5,240
|
(3,890)
|
11,141
|
(31,471)
|
Change in fair value
of contingent and variable consideration
|
(289)
|
(205)
|
1,586
|
(640)
|
Contract asset
impairment(2)
|
-
|
-
|
-
|
23,621
|
Foreign currency loss
(gain)
|
(1,146)
|
201
|
1,441
|
(1,517)
|
Inventory
step-up
|
358
|
1,580
|
1,059
|
4,104
|
Other losses
(gains)
|
(31)
|
131
|
(1,413)
|
892
|
Adjusted
EBITDA
|
6,565
|
7,784
|
22,201
|
18,672
|
|
|
(1)
|
As a result of the
increase in the share price in the current three-month period,
combined with an increase in the volatility, partially offset by a
decrease in the risk-adjusted discount rate, the value of the
Company's derivative liabilities increased and the Company
recognized a net non-cash charge of $5.2 million and $11.1 million
on the change in fair value of derivative liabilities for the three
and nine months ended September 30, 2020.
|
(2)
|
In the nine months
ended September 30, 2019, the Company recognized a non-cash $23.6
million impairment charge related to the Vimovo contract
asset.
|
Management to Host Conference Call/Webcast
Management
will host a conference call to discuss the results today
(Monday, November 16, 2020) at
8:30 a.m. ET. To participate in
the conference call, please dial 416 764 8688 or 1 888 390
0546. Please call in 15 minutes prior to the call to secure a
line. You will be put on hold until the conference call
begins.
A taped replay of the conference call will be available two
hours after the live conference call and will be accessible until
midnight on November 23, 2020 by
calling 416 764 8677 or 1 888 390 0541 / replay passcode:
499774#.
A live audio webcast of the conference call will be available
through www.nuvopharmaceuticals.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 Nuvo Pharmaceuticals Inc
Nuvo (TSX: NRI; OTCQX:
NRIFF) is a Canadian focused, healthcare company with global reach
and a diversified portfolio of commercial products. The
Company's products target several therapeutic areas, including
pain, allergy and dermatology. The Company's strategy is to
in-license and acquire growth-oriented, complementary products for
Canadian and international markets. Nuvo's head office is
located in Mississauga, Ontario,
Canada, the international operations are located in
Dublin, Ireland and its
manufacturing facility is located in Varennes, Québec, Canada. The
Varennes facility operates in a
Good Manufacturing Practices (GMP) environment respecting the U.S,
Canada and E.U. GMP regulations
and is regularly inspected by Health Canada and the U.S. Food and
Drug Administration. For additional information, please visit
www.nuvopharmaceuticals.com.
Forward-Looking Statements
This press release
contains "forward-looking information" as defined under Canadian
securities laws (collectively, "forward-looking statements"). The
words "plans", "expects", "does not expect", "goals", "seek",
"strategy", "future", "estimates", "intends", "anticipates", "does
not anticipate", "projected", "believes" or variations of such
words and phrases or statements to the effect that certain actions,
events or results "may", "will", "could", "would", "should",
"might", "likely", "occur", "be achieved" or "continue" and similar
expressions identify forward-looking statements. In addition, any
statements that refer to expectations, intentions, projections or
other characterizations of future events or circumstances contain
forward-looking statements.
Forward-looking statements are not historical facts but
instead represent management's expectations, estimates and
projections regarding future events or circumstances, including the
anticipated receipt of certain milestone and royalty payments, the
anticipated launch of certain products and the potential impact of
COVID-19. Such forward-looking statements are qualified in their
entirety by the inherent risks, uncertainties and changes in
circumstances surrounding future expectations which are difficult
to predict and many of which are beyond the control of the Company.
Forward-looking statements are necessarily based on a number of
estimates and assumptions that, while considered reasonable by
management of the Company as of the date of this press release, are
inherently subject to significant business, economic and
competitive uncertainties and contingencies and may prove to be
incorrect. Material factors and assumptions used to develop the
forward-looking statements, and material risk factors that could
cause actual results to differ materially from the forward-looking
statements, include but are not limited to, the validity of the
'907 and '285 Patents claims, the outcome of ongoing patent
litigation, the potential impact of COVID-19 on the Company's
operations, business and financial results and other factors, many
of which are beyond the control of Nuvo. Additional factors
that could cause Nuvo's actual results and financial condition to
differ materially from those indicated in the forward-looking
statements include, among others, the risk factors included in
Nuvo's most recent Annual Information Form dated February 24, 2020 under the heading "Risks
Factors", and as described from time to time in the reports and
disclosure documents filed by Nuvo with Canadian securities
regulatory agencies and commissions. These and other factors should
be considered carefully and readers should not place undue reliance
on Nuvo's forward-looking statements. Forward-looking statements
should not be read as guarantees of future performance or results
and will not necessarily be accurate indications of whether or not
the times at or by which such performance or results will be
achieved.
All forward-looking statements are based only on information
currently available to the Company and are made as of the date of
this press release. Except as expressly required by applicable
Canadian securities law, the Company assumes no obligation to
publicly update or revise any forward-looking statement, whether as
a result of new information, future events or otherwise. All
forward-looking statements in this press release are qualified by
these cautionary statements.
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SOURCE Nuvo Pharmaceuticals Inc.