DUBLIN, Aug. 3, 2021 /PRNewswire/ -- Theravance
Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ:
TBPH) today reported financial results for the second quarter of
2021.
"We made strong progress in the second quarter. Our field
team is energized and has recently been able to increase its
face-to-face engagements with customers, driving continued sales
volume and market share growth. As we look to the future for
YUPELRI, we and our partner Viatris are initiating a controlled
clinical study intended to provide data for a possible label
update," said Rick E Winningham, Chief Executive Officer. "We
continued to execute across our clinical trials and eagerly
anticipate study results this quarter and later this year/early
next. 2021 is a pivotal year for Theravance Biopharma, and we
are looking forward to the second half of the year furthering our
mission of medicines that make a difference."
Upcoming Clinical Milestones
- Q3 2021: Izencitinib (gut-selective oral pan-Janus
kinase (JAK) inhibitor for inflammatory intestinal diseases) Phase
2b in ulcerative colitis (study 0157)
– top-line results expected in Q3 2021.
- Q3 2021: Ampreloxetine (norepinephrine reuptake
inhibitor) Phase 3 for symptomatic neurogenic orthostatic
hypotension (study 0169) – enrollment complete and top-line results
expected in Q3 2021.
- Q4 2021/Q1 2022: Izencitinib (gut-selective oral pan-JAK
inhibitor for inflammatory intestinal diseases) Phase 2 in Crohn's
disease (study 0173) – top-line results expected in late Q4
2021/early Q1 2022.
Quarterly Highlights
- YUPELRI® (revefenacin) inhalation
solution, the first and only once-daily, nebulized bronchodilator
approved in the U.S. 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 21% in April
2021, up from 19% in January
2021, and net sales increased by 38% year-over-year (Q2 2020
vs. Q2 2021).
-
- The Company, in collaboration with our partner Viatris, is also
initiating a Phase 4 study comparing improvements in lung function
in adults with severe to very severe COPD and suboptimal
inspiratory flow rate following once-daily treatment with either
YUPELRI® (revefenacin) delivered via standard jet
nebulizer or tiotropium delivered via a dry powder inhaler
(Spiriva® HandiHaler®). This study is aimed
at helping to better inform decisions when physicians are designing
a personalized COPD treatment plan with patients.
- Nezulcitinib, an investigational, inhaled,
lung-selective, pan-JAK inhibitor in development for hospitalized
patients with COVID-19, reported Phase 2 top-line results (read
more about the data here).
- On June 29, 2021, the Company
closed a public offering of ordinary shares at a price to the
public of $15.00 per share, with
gross proceeds of $115.6 million,
before deducting underwriting discounts and commissions and
offering expenses.
Economic Interest
- TRELEGY (first once-daily single inhaler triple therapy
for COPD and asthma), in which the Company holds an economic
interest, posted second quarter 2021 global net sales of
$405 million (up from $241 million, 68%, in the second quarter of
2020); Theravance Biopharma is entitled to tiered payments equal to
approximately 5.5% to 8.5% of TRELEGY global net
sales.3
Second Quarter Financial Results
- Revenue: Total revenue for the second quarter of 2021
was $12.9 million, comprised of
non-cash collaboration revenue of $2.0
million primarily attributed to our global collaboration
with Janssen and $10.9 million in
Viatris collaboration revenue. Total revenue for the second quarter
represents a $2.1 million decrease
over the same period in 2020.
- YUPELRI: The Viatris collaboration revenue of
$10.9 million for the second quarter
of 2021 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
second quarter of 2021 was $14.6
million.
- Research and Development (R&D) Expenses: R&D
expenses for the second quarter of 2021 were $51.1 million, compared to $62.4 million in the same period in 2020. Second
quarter R&D expenses included total non-cash share-based
compensation of $7.3 million.
- Selling, General and Administrative (SG&A) Expenses:
SG&A expenses for the second quarter of 2021 were $25.9 million, compared to $24.8 million in the same period in 2020. Second
quarter SG&A expenses included total non-cash share-based
compensation of $7.6 million.
- Operating Loss: Operating loss for the second quarter of
2021 was $64.1 million compared to
$72.2 million in the same period of
2020.
- Cash Position: Cash, cash equivalents and marketable
securities totaled $265.0 million as
of June 30, 2021.
2021 Financial Guidance
- Operating Expenses (excluding share-based
compensation): The Company reiterates that it expects full
year 2021 R&D expense of $195
million to $225 million, and
SG&A expense of $80 million to
$90 million.
Conference Call and Live Webcast Today at 5 pm ET
Theravance Biopharma will hold a conference call and live
webcast accompanied by slides today at 5 pm
ET / 2 pm PT / 10 pm IST. To participate, please dial (855)
296-9648 from the U.S. or (920) 663-6266 for international callers,
using the confirmation code 2615108. Those interested in listening
to the conference call live via the internet may do so by visiting
www.theravance.com, under the Investors section, Presentations and
Events.
A replay will be available on www.theravance.com for 30 days
through September 2, 2021. An audio
replay will also be available through 8:00
p.m. ET on August 10, 2021, by
dialing (855) 859-2056 from the U.S., or (404) 537-2406 for
international callers, and then entering confirmation code
2615108.
About Theravance Biopharma
Theravance Biopharma, Inc. is a diversified biopharmaceutical
company primarily focused on the discovery, development and
commercialization of organ-selective medicines. Its purpose is to
pioneer a new generation of small molecule drugs designed to better
meet patient needs. Its research is focused in the areas of
inflammation and immunology.
In pursuit of its purpose, Theravance Biopharma applies insights
and innovation at each stage of its business and utilizes its
internal capabilities and those of partners around the world. The
Company applies organ-selective expertise to target disease
biologically, to discover and develop medicines that may expand the
therapeutic index with the goal of maximizing efficacy and limiting
systemic side effects. These efforts leverage years of experience
in developing lung-selective medicines to treat respiratory
disease, including FDA-approved YUPELRI® (revefenacin)
inhalation solution indicated for the maintenance treatment of
patients with chronic obstructive pulmonary disease (COPD). Its
pipeline of internally discovered programs is targeted to address
significant patient 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 U.S. 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 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, the Company's expectations for product candidates
through development, the Company's expectations regarding its
allocation of resources, potential regulatory approval and
commercialization (including their differentiation from other
products or potential products), 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 or product
candidates are unsafe, ineffective or not differentiated, risks
that product candidates do not obtain approval from regulatory
authorities, the feasibility of undertaking future clinical trials
for our product candidates 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. 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 (including but not limited to our later stage clinical
programs for izencitinib and ampreloxetine), 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-Q filed with the
SEC on May 6, 2021 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 in 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 in 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)
|
|
|
|
|
|
|
|
|
June
30,
|
|
December
31,
|
|
2021
|
|
2020
|
Assets
|
(Unaudited)
|
|
(1)
|
Current
assets:
|
|
|
|
Cash and cash
equivalents and short-term marketable securities
|
$
|
264,953
|
|
$
|
292,941
|
Receivables from
collaborative arrangements
|
|
12,220
|
|
|
15,868
|
Amounts due from TRC,
LLC
|
|
27,741
|
|
|
53,799
|
Prepaid clinical and
development services
|
|
15,913
|
|
|
20,374
|
Other prepaid and
current assets
|
|
12,353
|
|
|
10,359
|
Total current
assets
|
|
333,180
|
|
|
393,341
|
Property and
equipment, net
|
|
16,583
|
|
|
16,422
|
Operating lease
assets
|
|
41,508
|
|
|
43,260
|
Equity in net assets
of TRC, LLC
|
|
35,822
|
|
|
12,750
|
Restricted
cash
|
|
833
|
|
|
833
|
Other
assets
|
|
1,325
|
|
|
2,451
|
Total
assets
|
$
|
429,251
|
|
$
|
469,057
|
|
|
|
|
|
|
Liabilities and
Shareholders' Deficit
|
|
|
|
|
|
Current
liabilities
|
$
|
67,127
|
|
$
|
123,571
|
Convertible senior
notes due 2023, net
|
|
227,499
|
|
|
226,963
|
Non-recourse notes
due 2035, net
|
|
375,069
|
|
|
372,873
|
Long-term operating
lease liabilities
|
|
57,768
|
|
|
47,220
|
Other long-term
liabilities
|
|
2,162
|
|
|
2,181
|
Shareholders'
deficit
|
|
(300,374)
|
|
|
(303,751)
|
Total liabilities and
shareholders' deficit
|
$
|
429,251
|
|
$
|
469,057
|
|
|
|
|
|
|
________________________________
|
|
|
|
|
|
|
|
|
|
|
|
(1)
The condensed consolidated balance sheet as of December 31, 2020
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,
2020.
|
THERAVANCE
BIOPHARMA, INC.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(In thousands,
except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
|
(Unaudited)
|
|
(Unaudited)
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration
revenue
|
|
$
|
1,980
|
|
$
|
5,488
|
|
$
|
5,852
|
|
$
|
12,120
|
Licensing
revenue
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
1,500
|
Viatris collaboration
agreement
|
|
|
10,934
|
|
|
9,520
|
|
|
21,319
|
|
|
21,250
|
Total
revenue
|
|
|
12,914
|
|
|
15,008
|
|
|
27,171
|
|
|
34,870
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development (1)
|
|
|
51,093
|
|
|
62,404
|
|
|
118,692
|
|
|
128,417
|
Selling,
general and administrative (1)
|
|
|
25,931
|
|
|
24,780
|
|
|
56,481
|
|
|
51,105
|
Total
costs and expenses
|
|
|
77,024
|
|
|
87,184
|
|
|
175,173
|
|
|
179,522
|
Loss from
operations
|
|
|
(64,110)
|
|
|
(72,176)
|
|
|
(148,002)
|
|
|
(144,652)
|
Income from
investment in TRC, LLC
|
|
|
21,926
|
|
|
21,381
|
|
|
38,473
|
|
|
34,896
|
Interest
expense
|
|
|
(11,612)
|
|
|
(11,391)
|
|
|
(23,485)
|
|
|
(21,332)
|
Loss on
extinguishment of debt
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
(15,464)
|
Interest and other
income (expense), net
|
|
|
1,171
|
|
|
(662)
|
|
|
937
|
|
|
798
|
Loss before income
taxes
|
|
|
(52,625)
|
|
|
(62,848)
|
|
|
(132,077)
|
|
|
(145,754)
|
Provision for income
tax benefit (expense)
|
|
|
220
|
|
|
(39)
|
|
|
(7)
|
|
|
(186)
|
Net
loss
|
|
$
|
(52,405)
|
|
$
|
(62,887)
|
|
$
|
(132,084)
|
|
$
|
(145,940)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
$
|
(0.80)
|
|
$
|
(1.00)
|
|
$
|
(2.03)
|
|
$
|
(2.39)
|
Shares used to
compute basic and diluted net loss per share
|
|
|
65,669
|
|
|
62,861
|
|
|
65,085
|
|
|
61,162
|
|
|
|
|
|
|
|
|
|
|
|
|
|
________________________________
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)Amounts
include share-based compensation expense as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
(In thousands)
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Research and
development
|
|
$
|
7,315
|
|
$
|
8,098
|
|
$
|
15,236
|
|
$
|
15,963
|
Selling, general and
administrative
|
|
|
7,626
|
|
|
8,487
|
|
|
15,537
|
|
|
15,898
|
Total share-based
compensation expense
|
|
$
|
14,941
|
|
$
|
16,585
|
|
$
|
30,773
|
|
$
|
31,861
|
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SOURCE Theravance Biopharma, Inc.