- Implied 35% share of YUPELRI® (revefenacin) net
sales1: $15.3M Q1 2022 up 19% from Q1
2021
- TRELEGY Q1 2022 global net sales: $454M, up 33% from Q1 20212
- Results from a Phase 3 study of ampreloxetine showed a
benefit in study patients with multiple system atrophy
(MSA)
- Restructuring process completed in Q1 2022
DUBLIN, May 5, 2022
/PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma"
or the "Company") (NASDAQ: TBPH) today reported financial results
for the first quarter of 2022.
"We continue to execute against our business plan, stay
disciplined in capital allocation, and 2022 remains on track to
become sustainably cash-flow positive by the second half of this
year and going forward on an annual
basis," said Rick E Winningham, Chief Executive
Officer. "Our team's perseverance as demonstrated by YUPELRI's
hospital sales performance and continued gain of hospital and
community market share creates a strong base for future
growth. Considering the benefit that ampreloxetine provided
to MSA patients in our Study 0170, we will define a path forward
through ongoing discussions with regulators and strategic
partners. We plan to continue to unlock value from our
pipeline throughout 2022."
Quarterly Highlights
- YUPELRI® (revefenacin) inhalation solution,
the first and only once-daily, nebulized bronchodilator approved in
the US for the maintenance treatment of patients with chronic
obstructive pulmonary disease (COPD), continued to increase its
share of the long-acting nebulized COPD market, increasing to 23.5%
through January 2022, up from 23.2%
in October 2021, and net sales
increased by 19% year-over-year (Q1 2022 vs Q1 2021).
- Ampreloxetine, an investigational, Theravance
Biopharma-discovered, potent, long-acting, once-daily
norepinephrine reuptake inhibitor in development for the treatment
of symptomatic neurogenic orthostatic hypotension (nOH). Phase 3
results (Study 0170) showed a benefit to MSA patients in the study
that was observed in multiple endpoints including Orthostatic
Hypotension Symptom Assessment (OHSA) composite, Orthostatic
Hypotension Daily Activities Scale (OHDAS) composite, Orthostatic
Hypotension Questionnaire (OHQ) composite and OHSA #1. (Read more
about the data here).
Economic Interest
- TRELEGY (first once-daily single inhaler triple therapy
for COPD and asthma), in which the Company holds an economic
interest, posted first quarter 2022 global net sales of
$454 million (up from $341 million, 33%, in first quarter of 2021);
Theravance Biopharma is entitled to tiered payments equal to
approximately 5.5% to 8.5% of TRELEGY global net
sales.3
First Quarter Financial
Results
- Revenue: Total revenue for the first quarter of 2022 was
$13.2 million, primarily comprised of
licensing revenue of $2.5 million
related to a development milestone payment from Pfizer for the
first patient dosed in a Phase 1 clinical trial of the
skin-selective pan-Janus kinase (JAK) inhibitor program and
$10.7 million in Viatris
collaboration revenue. Total revenue for the first quarter
represents a $1.1 million decrease
over the same period in 2021 driven by the completion of the
recognition of non-cash Janssen collaboration revenue in 2021,
resulting from the planned close-out of the izencitinib
program.
- YUPELRI: The Viatris collaboration revenue of
$10.7 million for the first quarter
of 2022 represents amounts receivable from Viatris and is comprised
of the Company's 35% share of net sales of YUPELRI as well as its
proportionate amount of the total shared costs incurred by the two
companies. The non-shared YUPELRI costs incurred by Theravance
Biopharma are recorded within operating expenses. While Viatris
records the total net sales of YUPELRI within its financial
statements, our implied 35% share of net sales of YUPELRI for the
first quarter of 2022 was $15.3
million, up 19% from the first quarter of 2021. We achieved
19% year-over-year growth in net sales, however, due to accounting
guidelines, our Viatris collaboration revenue increased by only 3%
due to lower costs incurred by Theravance Biopharma as a result of
the corporate restructuring, which improves YUPELRI profitability
but lowers Viatris collaboration revenue.
- Research and Development (R&D) Expenses: R&D
expenses for the first quarter of 2022 were $23.3 million, compared to $67.6 million in the same period in 2021. First
quarter R&D expenses included total non-cash share-based
compensation of $4.5 million.
- Selling, General and Administrative (SG&A) Expenses:
SG&A expenses for the first quarter of 2022 were $19.1 million, compared to $30.6 million in the same period in 2021. First
quarter SG&A expenses included total non-cash share-based
compensation of $5.5 million.
- Restructuring and Related Expenses: Restructuring
expenses for the first quarter of 2022 were $9.3 million and primarily comprised of severance
costs, termination-related benefits, one-time retention costs, and
share-based compensation expense. Cash restructuring expenses were
$4.8 million for the first quarter of
2022; and non-cash restructuring expenses were $4.5 million for the first quarter of 2022.
- Operating Loss: Operating loss for the first quarter of
2022 was $38.5 million compared to
$83.9 million in the same period of
2021.
- Cash Position: Cash, cash equivalents and marketable
securities totaled $147.5 million as
of March 31, 2022.
2022 Financial Guidance
- Operating Expenses (excluding share-based compensation
and one-time restructuring costs): The Company expects full
year 2022 R&D expense of $45
million to $55 million and
SG&A expense of $35 million to
$45 million.
- The Company expects to be sustainably cash-flow positive
beginning 2H 2022 and going forward on an annual basis.
Conference Call and Live Webcast
Today at 5:00 pm ET
Theravance Biopharma will hold a conference call and live
webcast accompanied by slides today at 5:00
pm ET / 2:00 pm PT /
10:00 pm IST. To participate
in the live call by telephone, please dial (800) 225-9448 from the
US, or (203) 518-9783 for international callers, using the
confirmation code TBPH0505. Those interested in listening to the
conference call live via the internet may do so by visiting
Theravance Biopharma's website at www.theravance.com, under the
Investors section, Presentations and Events.
A replay of the conference call will be available on Theravance
Biopharma's website for 30 days through June
4, 2022. An audio replay will also be available through
11:59 pm ET on May 12, 2022, by dialing (800) 839-1337 from the
US, or (402) 220-0489 for international callers.
About Theravance
Biopharma
Theravance Biopharma, Inc. is a biopharmaceutical company
primarily focused on the discovery, development and
commercialization of respiratory medicines. Its core purpose is to
create medicines that make a difference® in
people's lives.
In pursuit of its purpose, Theravance Biopharma leverages
decades of respiratory expertise to discover and develop
transformational medicines that make a difference. These efforts
have led to the development of FDA-approved
YUPELRI® (revefenacin) inhalation solution
indicated for the maintenance treatment of patients with chronic
obstructive pulmonary disease (COPD). Its respiratory pipeline of
internally discovered programs is targeted to address significant
patient respiratory needs.
Theravance Biopharma has an economic interest in potential
future payments from Glaxo Group Limited or one of its
affiliates (GSK) pursuant to its agreements with Innoviva, Inc.
relating to certain programs, including TRELEGY.
For more information, please visit www.theravance.com.
THERAVANCE BIOPHARMA®, THERAVANCE®, and
the Cross/Star logo are registered trademarks of
the Theravance Biopharma group of companies (in
the US and certain other countries).
YUPELRI® is a registered trademark of Mylan
Specialty L.P., a Viatris Company. Trademarks, trade names or
service marks of other companies appearing on this press release
are the property of their respective owners.
Forward-Looking
Statements
This press release contains and the conference call will contain
certain "forward-looking" statements as that term is defined in the
Private Securities Litigation Reform Act of 1995 regarding, among
other things, statements relating to goals, plans, objectives,
expectations and future events. Theravance Biopharma intends such
forward-looking statements to be covered by the safe harbor
provisions for forward-looking statements contained in Section 21E
of the Securities Exchange Act of 1934 and the Private Securities
Litigation Reform Act of 1995. Examples of such statements include
statements relating to: the Company's goals, designs, strategies,
plans and objectives, the impact of the Company's restructuring
plan, ability to provide value to shareholders, the Company's
regulatory strategies and timing of clinical studies (including the
data therefrom), the potential characteristics, benefits and
mechanisms of action of the Company's product and product
candidates, the potential that the Company's research programs will
progress product candidates into the clinic or will be partnered
successfully, the Company's expectations for product candidates
through development and the market for products being
commercialized, the Company's expectations regarding its allocation
of resources, potential regulatory actions and commercialization
(including differentiation from other products or potential
products and addressable market), product sales or profit share
revenue and the Company's expectations for its expenses, excluding
share-based compensation and other financial results. These
statements are based on the current estimates and assumptions of
the management of Theravance Biopharma as of the date of the press
release and the conference call and are subject to risks,
uncertainties, changes in circumstances, assumptions and other
factors that may cause the actual results of Theravance Biopharma
to be materially different from those reflected in the
forward-looking statements. Important factors that could cause
actual results to differ materially from those indicated by such
forward-looking statements include, among others, risks related to:
disagreements with Innoviva, Inc. and TRC LLC, the uncertainty of
arbitration and litigation and the possibility that the results of
these proceedings could be adverse to the Company, additional
future analysis of the data resulting from our clinical trial(s),
delays or difficulties in commencing, enrolling or completing
clinical studies, the potential that results from clinical or
non-clinical studies indicate the Company's compounds, products or
product candidates are unsafe, ineffective or not differentiated,
risks of decisions from regulatory authorities that are unfavorable
to the Company, the feasibility of undertaking future clinical
trials based on policies and feedback from regulatory authorities,
dependence on third parties to conduct clinical studies, delays or
failure to achieve and maintain regulatory approvals for product
candidates, risks of collaborating with or relying on third parties
to discover, develop, manufacture and commercialize products, and
risks associated with establishing and maintaining sales, marketing
and distribution capabilities with appropriate technical expertise
and supporting infrastructure, ability to retain key personnel, the
impact of the Company's restructuring actions on its employees,
partners and others. In addition, while we expect the effects of
COVID-19 to continue to adversely impact our business operations
and financial results, the extent of the impact on our ability to
generate revenue from YUPELRI® (revefenacin), our
clinical development programs, and the value of and market for our
ordinary shares, will depend on future developments that are highly
uncertain and cannot be predicted with confidence at this time.
These potential future developments include, but are not limited
to, the ultimate duration of the COVID-19 pandemic, travel
restrictions, quarantines, social distancing and business closure
requirements in the United States
and in other countries, other measures taken by us and those we
work with to help protect individuals from contracting COVID-19,
and the effectiveness of actions taken globally to contain and
treat the disease, including vaccine availability, distribution,
acceptance and effectiveness. Other risks affecting Theravance
Biopharma are in the Company's Form 10-K filed with the SEC on
February 28, 2022, and other periodic
reports filed with the SEC. In addition to the risks described
above and in Theravance Biopharma's filings with the SEC, other
unknown or unpredictable factors also could affect Theravance
Biopharma's results. No forward-looking statements can be
guaranteed, and actual results may differ materially from such
statements. Given these uncertainties, you should not place undue
reliance on these forward-looking statements. Theravance Biopharma
assumes no obligation to update its forward-looking statements on
account of new information, future events or otherwise, except as
required by law.
Contact: Gail B. Cohen
Corporate Communications / 917-214-6603
1
|
While Viatris, Inc.
("Viatris") records the total YUPELRI net sales, the Company is
entitled to a 35% share of the profits and losses pursuant to a
co-promotion agreement with Viatris.
|
2
|
As reported by Glaxo
Group Limited or one of its affiliates (GSK); reported sales
converted to USD; economic interest related to TRELEGY (the
combination of fluticasone furoate, umeclidinium, and vilanterol
(FF/UMEC/VI), jointly developed by GSK and Innoviva, Inc.) entitles
the Company to upward tiering payments equal to approximately 5.5%
to 8.5% on worldwide net sales of the product (net of Theravance
Respiratory Company, LLC (TRC) expenses paid and the amount of
cash, if any, expected to be used by TRC over the next four fiscal
quarters). 75% of the income from the Company's investment in TRC
is pledged to service outstanding notes and 25% of income from the
Company's investment in TRC is retained by the
Company.
|
3
|
As reported by Glaxo
Group Limited or one of its affiliates (GSK); reported sales
converted to USD; economic interest related to TRELEGY (the
combination of fluticasone furoate, umeclidinium, and vilanterol
(FF/UMEC/VI), jointly developed by GSK and Innoviva, Inc.) entitles
the Company to upward tiering payments equal to approximately 5.5%
to 8.5% on worldwide net sales of the product (net of Theravance
Respiratory Company, LLC (TRC) expenses paid and the amount of
cash, if any, expected to be used by TRC over the next four fiscal
quarters). 75% of the income from the Company's investment in TRC
is pledged to service outstanding notes and 25% of income from the
Company's investment in TRC is retained by the
Company.
|
|
|
|
|
|
|
THERAVANCE
BIOPHARMA, INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(In
thousands)
|
|
|
|
|
|
|
|
|
March
31,
|
|
December
31,
|
|
2022
|
|
2021
|
Assets
|
(Unaudited)
|
|
(1)
|
Current
assets:
|
|
|
|
Cash and cash
equivalents and short-term marketable securities
|
$
|
147,516
|
|
$
|
173,465
|
Receivables from
collaborative arrangements
|
|
12,277
|
|
|
14,065
|
Amounts due from TRC,
LLC
|
|
35,559
|
|
|
43,534
|
Prepaid clinical and
development services
|
|
4,742
|
|
|
10,245
|
Other prepaid and
current assets
|
|
4,542
|
|
|
8,561
|
Total current
assets
|
|
204,636
|
|
|
249,870
|
Property and equipment,
net
|
|
13,236
|
|
|
13,657
|
Operating lease
assets
|
|
39,349
|
|
|
39,690
|
Equity in net assets of
TRC, LLC
|
|
94,108
|
|
|
67,537
|
Restricted
cash
|
|
836
|
|
|
837
|
Other assets
|
|
3,194
|
|
|
3,228
|
Total
assets
|
$
|
355,359
|
|
$
|
374,819
|
|
|
|
|
|
|
Liabilities and
Shareholders' Deficit
|
|
|
|
|
|
Current
liabilities
|
$
|
44,201
|
|
$
|
58,587
|
Convertible senior
notes due 2023, net
|
|
228,303
|
|
|
228,035
|
Non-recourse notes due
2035, net
|
|
384,161
|
|
|
371,359
|
Long-term operating
lease liabilities
|
|
47,415
|
|
|
52,681
|
Other long-term
liabilities
|
|
2,729
|
|
|
2,730
|
Shareholders'
deficit
|
|
(351,450)
|
|
|
(338,573)
|
Total liabilities and
shareholders' deficit
|
$
|
355,359
|
|
$
|
374,819
|
|
|
|
|
|
|
________________________________
|
|
|
|
|
|
|
|
|
|
|
|
(1) The condensed consolidated balance sheet as of
December 31, 2021 has been derived from the audited consolidated
financial
statements included in the Company's
Annual Report on Form 10-K for the year ended December 31,
2021.
|
|
|
|
|
|
|
|
THERAVANCE
BIOPHARMA, INC.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(In thousands,
except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
2022
|
|
2021
|
|
|
(Unaudited)
|
Revenue:
|
|
|
|
|
|
|
Viatris collaboration
agreement
|
|
$
|
10,687
|
|
$
|
10,385
|
Collaboration
revenue
|
|
|
9
|
|
|
3,872
|
Licensing
revenue
|
|
|
2,500
|
|
|
-
|
Total
revenue
|
|
|
13,196
|
|
|
14,257
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
Research
and development (1)
|
|
|
23,253
|
|
|
67,599
|
Selling,
general and administrative (1)
|
|
|
19,121
|
|
|
30,550
|
Restructuring and related expenses (1)
|
|
|
9,324
|
|
|
-
|
Total
costs and expenses
|
|
|
51,698
|
|
|
98,149
|
Loss from
operations
|
|
|
(38,502)
|
|
|
(83,892)
|
Income from investment
in TRC, LLC
|
|
|
25,110
|
|
|
16,547
|
Interest
expense
|
|
|
(11,655)
|
|
|
(11,873)
|
Interest income and
other income (expense), net
|
|
|
(375)
|
|
|
(234)
|
Loss before income
taxes
|
|
|
(25,422)
|
|
|
(79,452)
|
Provision for income
tax expense
|
|
|
(524)
|
|
|
(227)
|
Net
loss
|
|
$
|
(25,946)
|
|
$
|
(79,679)
|
|
|
|
|
|
|
|
Net loss per
share:
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
$
|
(0.34)
|
|
$
|
(1.24)
|
Shares used to compute
basic and diluted net loss per share
|
|
|
75,247
|
|
|
64,493
|
|
|
|
|
|
|
|
________________________________
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
Amounts include share-based compensation
expense as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
(In thousands)
|
|
2022
|
|
2021
|
Research and
development
|
|
$
|
4,530
|
|
$
|
7,921
|
Selling, general and
administrative
|
|
|
5,498
|
|
|
7,911
|
Restructuring and
related expenses
|
|
|
4,517
|
|
|
-
|
Total share-based
compensation expense
|
|
$
|
14,545
|
|
$
|
15,832
|
|
|
|
|
|
|
|
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SOURCE Theravance Biopharma, Inc.