- Q3 2023 YUPELRI® (revefenacin) net sales,
recognized by Viatris, increased 9% from Q3 2022, reaching an
all-time high of $58.3
million1
- Progress made towards the achievement of non-GAAP
profitability, with Q3 2023 GAAP Net Loss of $9.0 million and Non-GAAP Loss of
$0.7
million2
- Company expects to complete $325
million capital return program by year-end, having returned
$30.8 million via share repurchases
during Q3 2023 and $294.6 million
since inception through quarter end
- Áine Miller, Ph.D. promoted to SVP of Development;
Richard A. Graham, Ph.D. to remain
through February 2024
DUBLIN, Nov. 7, 2023
/PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma"
or the "Company") (NASDAQ: TBPH) today announced financial and
operational results for the third quarter of 2023.
"We are pleased with the company's bottom line performance in
the third quarter, driven by a combination of continued YUPELRI
growth and expense management, which positioned us to report a
non-GAAP loss of less than $1
million," said Rick E Winningham, Chief Executive
Officer. "In addition, as we work with the MSA community to
activate sites globally and enroll our Phase 3 CYPRESS study, our
conviction in ampreloxetine's potential to address unmet needs of
MSA patients and caregivers burdened by symptomatic nOH remains
strong."
"With her extensive contributions at Theravance and prior
strategic development and regulatory leadership
experience at Alkermes, Elan, and Allergan, Aine is
well positioned to lead the Development organization through
completion of the CYPRESS study, NDA submission and beyond,"
said Rick E Winningham. "I am pleased that Rick will stay
through February to ensure we meet our PIFR-2 commitments and
maintain our momentum in CYPRESS but will miss his steadfast
leadership and camaraderie – he has been an important partner
in Theravance's success."
Third Quarter Highlights
YUPELRI® (revefenacin) inhalation
solution, the first and only once-daily, nebulized LAMA (long-
acting muscarinic agent) bronchodilator approved in
the US for the maintenance treatment of patients with
chronic obstructive pulmonary disease (COPD):
- Achieved total net sales of $58.3
million for the quarter, increasing 9% year-over-year (Q3
2023 vs Q3 2022) and 6% quarter-over-quarter (Q3 2023 vs Q2
2023).1 Sales growth was driven by increasing customer
demand, up 14% year-over-year.3
- Grew Retail TRx by 30% (Q3 2023 vs Q3 2022)4 and
doses sold into the hospital channel by 41% year-over-year (Q3 2023
vs Q3 2022).
- Increased share within the long-acting nebulized segment of the
COPD market. During the quarter, share within the community and
hospital settings increased to 30.2% and 16.1%, respectively, from
26.4% and 13.3% in Q3 2022.5
- Completed enrollment in the PIFR-2 study, with top line data
disclosure anticipated for January
2024. PIFR-2 study evaluates revefenacin delivered via jet
nebulizer compared to tiotropium delivered via dry powder inhaler
in severe to very severe COPD patients with low peak inspiratory
flow rate (PIFR).
Ampreloxetine, an investigational, once-daily
norepinephrine reuptake inhibitor in development for the treatment
of symptomatic neurogenic orthostatic hypotension (nOH) in patients
with multiple system atrophy (MSA):
- Presented new data at the International Congress of Parkinson's
Disease and Movement Disorders Congress (MDS) in Copenhagen, Denmark in August. Presentations
highlighted ampreloxetine's consistent effects on nOH symptoms
across a range of MSA subjects, in addition to a highly
differentiated efficacy and safety profile.
- Data to be presented at the 34th International
Symposium on the Autonomic Nervous System on November 16th.
- Continued to open sites globally for the CYPRESS study, with
the expectation of enrolling the last patient into the open-label
period of the study in the second half of 2024.
Financials:
- Q3 2023 GAAP Net Loss of $9.0
million and Non-GAAP Loss of $0.7
million compared with net losses of $15.6 million and $7.4
million, respectively, in Q2 2023. Sequential improvement in
Net Loss was driven primarily by increased Viatris Collaboration
Revenue and a reduction in expenses across R&D and SG&A.
Within SG&A, the largest driver of the decrease was due to
expense management initiatives taken within the G&A
organization.
- Completed $30.8 million of share
buybacks in Q3 2023 and $294.6
million from program inception through September 30, 2023. As of September 30, 2023, the Company had $30.4 million remaining in the program, which is
expected to be completed by the end of 2023.
TRELEGY ELLIPTA, the first once-daily single inhaler
triple therapy for COPD and asthma:
- GSK posted third quarter 2023 global net sales of $675 million (up 22% from $552 million reported in the third quarter of
2022).6 Year to date, through the third quarter, GSK has
posted TRELEGY global net sales of $2.0
billion. Theravance Biopharma is entitled to a milestone
payment from Royalty Pharma of $50
million if TRELEGY global net sales are equal to or exceed
$2.9 billion7 in 2023, the
first of $250 million of potential
milestones that can be achieved between 2023 and 2026.
Third Quarter Financial Results
- Revenue: Total revenue for the third quarter of 2023 was
$15.7 million, consisting almost
entirely of Viatris collaboration revenue. Viatris collaboration
revenue increased by $3.2 million, or
26%, in the third quarter compared to the same period in 2022 due
primarily to higher net sales and lower costs incurred by Viatris.
The Viatris collaboration revenue represents amounts receivable
from Viatris and comprises 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, Theravance Biopharma's implied 35%
share of net sales of YUPELRI for the third quarter of 2023 was
$20.4 million which represents a 9%
increase compared to the same period in 2022.
- Research and Development (R&D) Expenses: R&D
expenses for the third quarter of 2023 were $8.3 million, compared to $9.9 million in the same period in 2022. Third
quarter R&D expenses included total non-cash share-based
compensation of $2.0 million.
- Selling, General and Administrative (SG&A) Expenses:
SG&A expenses for the third quarter of 2023 were $16.1 million, compared to $16.3 million in the same period in 2022. Third
quarter SG&A expenses included total non-cash share-based
compensation of $4.3 million.
- Stock Based Compensation: Share-based compensation
expenses for the third quarter of 2023 were $6.3 million, compared to $8.5 million in the same period in 2022.
Share-based compensation expenses consisted of $2.0 million for R&D and $4.3 million for SG&A in the third quarter of
2023, compared to $2.6 million and
$5.2 million, respectively, in the
same period in 2022. In the third quarter of 2022, there was also
$0.7 million in restructuring-related
share-based compensation expense. The $2.3
million reduction in total share-based compensation expenses
was primarily related to our 2021 restructuring and our 2023
strategic actions.
- Net Income from Discontinued Operations: Net Income from
discontinued operations from the prior year period of $932.7 million was primarily related to the
$1,141.1 million gain from the sale
of our equity interests in TRC, LLC and was partially offset by the
tax liability arising from the gain and a $24.0 million loss on the extinguishment of our
non-recourse 2035 notes.
- Net Loss from Operations and Non-GAAP Net Loss (from
continuing operations)2: Net loss from continuing
operations was $9.0 million in the
third quarter of 2023 compared to $16.0
million in the same period in 2022, and non-GAAP net loss
from continuing operations was $0.7
million in the third quarter of 2023 compared to
$7.1 million in the same period in
2022. Non-GAAP net loss from continuing operations consists of GAAP
net income (loss) from operations, excluding share-based
compensation expense, non-cash interest expense, and income tax
expense (benefit). See the section titled "Non-GAAP Financial
Measures" for more information.
- Cash Position: Cash, cash equivalents and
marketable securities totaled $134.0
million as of September 30,
2023.
2023 Financial Guidance
- Operating Expenses (excluding share-based compensation
and one-time restructuring costs): The Company continues to
expect full year 2023 R&D expense of $35
million to $45 million and
SG&A expense of $45 million to
$55 million.
- Non-GAAP Profitability: The Company reaffirms its
expectation that it will generate non-GAAP profit in 2H 2023,
subject to YUPELRI's increased net sales growth.2
R&D Leadership
Effective November 7, 2023, Áine
Miller, Ph.D., will assume the role of SVP, Development at
Theravance Biopharma, replacing Richard A Graham, Ph.D. Dr.
Miller has been with the company for nearly four years in
increasing positions of leadership and currently serves as the
company's Vice President, Regulatory, Quality and Clinical Safety
& Pharmacovigilance. Dr. Miller led Theravance's Type C
meeting with the FDA, reaching alignment on the design of the
ampreloxetine Cypress study, our single Phase 3 study to support US
approval. Rick Graham, Ph.D., will
be leaving the company after eight years of significant
contributions towards establishing and optimizing Theravance
Biopharma's development capabilities. Rick will continue in a
strategic advisor role through the read out and communication of
the PIFR-2 study results and will work towards a seamless
transition through the end of February
2024.
2024 Annual General Meeting of Shareholders; Board of
Directors
The Company will hold its 2024 Annual General Meeting of
Shareholders on May 8, 2024 in
Dublin, Ireland (2024 AGSM).
Dr. Burton Malkiel has informed the
Company that he does not intend to stand for re-election at the
2024 AGSM. Reflecting better alignment with the smaller size
and focus of the Company, the Board has approved reducing the size
of the Board from 9 persons to 8 persons effective automatically
upon the completion of Dr. Malkiel's term at the 2024
AGSM.
Settlement Agreement
On October 27, 2023, certain
subsidiaries of Theravance Biopharma and Mylan Ireland Limited and
Mylan Specialty L.P. (together, "Viatris") entered into a
Settlement Agreement with Teva Pharmaceuticals, Inc. and Teva
Pharmaceuticals USA, Inc.
(together, "Teva"), relating to Theravance and Viatris's
YUPELRI® (revefenacin) inhalation solution. The
Settlement Agreement resolves ongoing patent litigation brought by
Theravance and Viatris against Teva pursuant to the Hatch-Waxman
Act based on Teva's filing of an abbreviated new drug application
seeking approval to market a generic version of YUPELRI®
(revefenacin) inhalation solution prior to expiration of the Orange
Book Listed Patents.
Under the Settlement Agreement, Theravance and Viatris granted
Teva a royalty-free, non-exclusive, non-sublicensable,
non-transferable license to manufacture and market Teva's generic
version of YUPELRI® (revefenacin) inhalation solution in
the United States on or after the
licensed launch date of April 23,
2039, subject to certain exceptions as is customary in these
types of agreements. As required by law, the settlement is
subject to review by the U.S. Department of Justice and the Federal
Trade Commission. The patent litigation previously disclosed
by the Company against the other six ANDA filers, along with
certain affiliates, remains pending.
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 GMT. To participate
in the live call by telephone, please register here. 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 webcast will be available on Theravance
Biopharma's website for 30 days through December 7, 2023.
About the PIFR-2 Study
This study is a randomized, double-blind,
parallel-group study, comparing improvements in lung function
in adults with severe to very severe COPD and low peak inspiratory
flow rate following once-daily treatment over 12 weeks with
either YUPELRI (revefenacin) inhalation solution delivered via
standard jet
nebulizer or SPIRIVA® (tiotropium) delivered
via a dry powder inhaler
(Spiriva® HandiHaler®).
About Ampreloxetine
Ampreloxetine, an investigational, once-daily norepinephrine
reuptake inhibitor in development for the treatment of symptomatic
neurogenic orthostatic hypotension (nOH) in patients with multiple
system atrophy (MSA). The unique benefits of ampreloxetine
treatment reported in MSA patients from Study 0170 included an
increase in norepinephrine levels, a favorable impact on blood
pressure, clinically meaningful and durable symptom improvement,
and no signal for supine hypertension. The company has been granted
an orphan drug designation in the US and, if results support it,
plans to file an NDA for full approval based on the Phase 3 CYPRESS
study.
About CYPRESS (Study 0197), a Phase 3 Study
Study 0197 (NCT05696717) is currently enrolling. This is
a registrational Phase 3, multi-center, randomized withdrawal
study to evaluate the efficacy and durability of ampreloxetine in
participants with MSA and symptomatic nOH after 20 weeks of
treatment; the primary endpoint of the study is change in the
Orthostatic Hypotension Symptom Assessment (OHSA) composite score.
The Study includes four periods: screening, open label (12-week
period, participants will receive a single daily 10 mg dose of
ampreloxetine), randomized withdrawal (eight-week period,
double-blind, placebo-controlled, participants will receive a
single daily 10 mg dose of placebo or ampreloxetine), and a
long-term treatment extension. Secondary outcome measures include
change from baseline in Orthostatic Hypotension Daily Activity
Scale (OHDAS) item 1 (activities that require standing for a short
time) and item 3 (activities that require walking for a short
time).
About Multiple System Atrophy (MSA) and Symptomatic
Neurogenic Orthostatic Hypotension (nOH)
MSA is a progressive brain disorder that affects movement and
balance and disrupts the function of the autonomic nervous system.
The autonomic nervous system controls body functions that are
mostly involuntary. One of the most frequent autonomic symptoms
associated with MSA is a sudden drop in blood pressure upon
standing (nOH).8 There are approximately
50,000 MSA patients in the US9 and 70-90% of MSA
patients experience nOH symptoms.10 Despite available
therapies, many MSA patients remain symptomatic with nOH.
Neurogenic orthostatic hypotension (nOH) is a rare disorder
defined as a fall in systolic blood pressure of ⩾20 mm Hg or
diastolic blood pressure of ⩾10 mm Hg, within 3 minutes of
standing. Severely affected patients are unable to stand for more
than a few seconds because of their decrease in blood pressure,
leading to cerebral hypoperfusion and syncope. A debilitating
condition, nOH results in a range of symptoms including dizziness,
lightheadedness, fainting, fatigue, blurry vision, weakness,
trouble concentrating, and head and neck pain.
About Theravance Biopharma
Theravance Biopharma, Inc.'s focus is to
deliver Medicines that Make a
Difference® in people's lives. In pursuit of
its purpose, Theravance Biopharma leverages decades of
expertise, which has led to the development of FDA-approved
YUPELRI® (revefenacin) inhalation solution
indicated for the maintenance treatment of patients with chronic
obstructive pulmonary disease (COPD). Ampreloxetine, its late-stage
investigational norepinephrine reuptake inhibitor in development
for symptomatic neurogenic orthostatic hypotension, has the
potential to be a first in class therapy effective in treating a
constellation of cardinal symptoms in multiple system atrophy
patients. The Company is committed to creating/driving shareholder
value.
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 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, as amended, and the Private
Securities Litigation Reform Act of 1995. Examples of such
statements include statements relating to: the Company's repurchase
of its ordinary shares by way of an open market share repurchase
program, the impact of recent headcount reductions in connection
with focusing investments in research, the Company's governance
policies and plans, the Company's expectations regarding its
allocation of resources and maintenance of expenditures, the
Company's goals, designs, strategies, plans and objectives, future
YUPELRI sales, the ability to provide value to shareholders, the
Company's regulatory strategies and timing of clinical studies,
possible safety, efficacy or differentiation of our investigational
therapy, and contingent payments due to the Company from the sale
of the Company's TRELEGY ELLIPTA royalty interests to Royalty
Pharma. These statements are based on the current estimates and
assumptions of the management of Theravance Biopharma as of the
date of this 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:
whether the milestone thresholds can be achieved, delays or
difficulties in commencing, enrolling or completing clinical
studies, the potential that results from clinical or non-clinical
studies indicate the Company's product candidates or product are
unsafe, ineffective or not differentiated, risks of decisions from
regulatory authorities that are unfavorable to the Company,
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 recent restructuring actions on its
employees, partners and others, the ability of the Company to
protect and to enforce its intellectual property rights, volatility
and fluctuations in the trading price and volume of the Company's
shares, and general economic and market conditions. Other risks
affecting Theravance Biopharma are in the Company's Form 10-Q filed
with the SEC on August 9, 2023, 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.
Non-GAAP Financial Measures
Theravance Biopharma provides a non-GAAP profitability target
and a non-GAAP metric in this press release. Theravance Biopharma
believes that the non-GAAP profitability target and non-GAAP net
loss from operations provide meaningful information to assist
investors in assessing prospects for future performance and actual
performance as they provide better metrics for analyzing the
performance of its business by excluding items that may not be
indicative of core operating results and the Company's cash
position. Because non-GAAP financial targets and metrics, such as
non-GAAP profitability and non-GAAP net loss from operations, are
not standardized, it may not be possible to compare these measures
with other companies' non-GAAP targets or measures having the same
or a similar name. Thus, Theravance Biopharma's non-GAAP measures
should be considered in addition to, not as a substitute for, or in
isolation from, the Company's actual GAAP results and other
targets.
Contact:
investor.relations@theravance.com
650-808-4045
1 In the US, Viatris is leading the commercialization
of YUPELRI, and the Company co-promotes the product under a profit
and loss sharing arrangement (65% to Viatris; 35% to the
Company).
2 Non-GAAP profit (loss) consists of GAAP net income
(loss) before taxes less share-based compensation expense and
non-cash interest expense. See the section titled "Non-GAAP
Financial Measures" for more information.
3 Viatris reported customer demand Q3'23: inclusive of
direct customer shipments to various channels, including DMEs,
retail pharmacies and hospitals.
4 Symphony Health METYS Prescription Dashboard. Retail
data serves as a proxy for the total community (Retail + DME).
5 Hospital LA-NEB Market Share - IQVIA DDD through
9/30/2023. Community LA-NEB Market Share includes Retail + DME
/ Med B FFS through July '23.
6 Source: GSK-reported Net Sales in
USD.
7 The first milestone payment of
$50.0 million will be triggered if
Royalty Pharma receives $240.0
million or more in royalty payments from GSK with respect to
2023 TRELEGY global net sales, which we would expect to occur in
the event TRELEGY global net sales reach approximately $2.863 billion. Royalties payable from GSK to
Royalty Pharma are upward tiering from 6.5% to 10%.
8
https://medlineplus.gov/genetics/condition/multiple-system-atrophy/
9 UCSD Neurological Institute (25K-75K, with ~10K
new cases per year); NIH National Institute of Neurological
Disorders and Stroke (15K-50K).
10 Delveinsight MSA Market Forecast (2023); Symptoms
associated with orthostatic hypotension in pure autonomic failure
and multiple systems atrophy, CJ Mathias (1999).
|
|
|
|
|
|
THERAVANCE
BIOPHARMA, INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(In
thousands)
|
|
|
|
|
|
|
|
September
30,
|
|
December
31,
|
|
2023
|
|
2022
|
Assets
|
(Unaudited)
|
|
(1)
|
Current
assets:
|
|
|
|
Cash and cash
equivalents and short-term marketable securities
|
$
|
134,003
|
|
$
|
327,484
|
Receivables from
collaborative arrangements
|
|
17,057
|
|
|
16,785
|
Prepaid clinical and
development services
|
|
1,634
|
|
|
1,513
|
Other prepaid and
current assets
|
|
8,996
|
|
|
7,682
|
Total current
assets
|
|
161,690
|
|
|
353,464
|
Property and equipment,
net
|
|
9,288
|
|
|
11,875
|
Operating lease
assets
|
|
37,576
|
|
|
40,126
|
Future contingent
milestone and royalty assets
|
|
194,200
|
|
|
194,200
|
Restricted
cash
|
|
836
|
|
|
836
|
Other assets
|
|
10,000
|
|
|
6,899
|
Total
assets
|
$
|
413,590
|
|
$
|
607,400
|
|
|
|
|
|
|
Liabilities and
Shareholders' Equity
|
|
|
|
|
|
Current
liabilities
|
$
|
25,368
|
|
$
|
28,715
|
Long-term operating
lease liabilities
|
|
41,118
|
|
|
45,407
|
Future royalty payment
contingency
|
|
27,165
|
|
|
25,438
|
Unrecognized tax
benefits
|
|
65,955
|
|
|
64,191
|
Other long-term
liabilities
|
|
7,854
|
|
|
1,849
|
Shareholders'
equity
|
|
246,130
|
|
|
441,800
|
Total liabilities and
shareholders' equity
|
$
|
413,590
|
|
$
|
607,400
|
|
|
|
|
|
|
|
(1) The condensed consolidated balance sheet as of
December 31, 2022 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,
2022.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
THERAVANCE
BIOPHARMA, INC.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(In thousands,
except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
|
(Unaudited)
|
|
(Unaudited)
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
Viatris collaboration
agreement (1)
|
|
$
|
15,687
|
|
$
|
12,445
|
|
$
|
39,841
|
|
$
|
34,010
|
Collaboration
revenue
|
|
|
6
|
|
|
6
|
|
|
18
|
|
|
187
|
Licensing
revenue
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
2,500
|
Total
revenue
|
|
|
15,693
|
|
|
12,451
|
|
|
39,859
|
|
|
36,697
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development (2)
|
|
|
8,311
|
|
|
9,867
|
|
|
32,308
|
|
|
48,044
|
Selling,
general and administrative (2)
|
|
|
16,142
|
|
|
16,277
|
|
|
54,603
|
|
|
50,341
|
Restructuring and related expenses (2)
|
|
|
-
|
|
|
509
|
|
|
2,743
|
|
|
12,838
|
Total
costs and expenses
|
|
|
24,453
|
|
|
26,653
|
|
|
89,654
|
|
|
111,223
|
Loss from
operations
|
|
|
(8,760)
|
|
|
(14,202)
|
|
|
(49,795)
|
|
|
(74,526)
|
Interest
expense
|
|
|
(609)
|
|
|
(1,545)
|
|
|
(1,727)
|
|
|
(5,819)
|
Loss on extinguishment
of debt
|
|
|
-
|
|
|
(3,034)
|
|
|
-
|
|
|
(3,034)
|
Interest income and
other income (expense), net
|
|
|
1,786
|
|
|
2,758
|
|
|
7,269
|
|
|
4,823
|
Loss from continuing
operations before income taxes
|
|
|
(7,583)
|
|
|
(16,023)
|
|
|
(44,253)
|
|
|
(78,556)
|
Provision for income
tax (expense) benefit
|
|
|
(1,367)
|
|
|
-
|
|
|
(2,430)
|
|
|
(12)
|
Net
loss from continuing operations
|
|
|
(8,950)
|
|
|
(16,023)
|
|
|
(46,683)
|
|
|
(78,568)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from
discontinued operations before income taxes
|
|
|
-
|
|
|
1,115,016
|
|
|
-
|
|
|
1,143,930
|
Provision for income
tax expense
|
|
|
-
|
|
|
(182,362)
|
|
|
-
|
|
|
(182,868)
|
Net
income from discontinued operations
|
|
|
-
|
|
|
932,654
|
|
|
-
|
|
|
961,062
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
(loss)
|
|
$
|
(8,950)
|
|
$
|
916,631
|
|
$
|
(46,683)
|
|
$
|
882,494
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share:
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing operations -
basic and diluted
|
|
$
|
(0.17)
|
|
$
|
(0.21)
|
|
$
|
(0.81)
|
|
$
|
(1.04)
|
Discontinued operations
- basic and diluted
|
|
$
|
-
|
|
$
|
12.35
|
|
$
|
-
|
|
$
|
12.70
|
Net income (loss) -
basic and diluted
|
|
$
|
(0.17)
|
|
$
|
12.14
|
|
$
|
(0.81)
|
|
$
|
11.66
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute
per share calculations - basic and diluted
|
|
|
52,361
|
|
|
75,515
|
|
|
57,287
|
|
|
75,678
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net loss
from continuing operations
|
|
$
|
(712)
|
|
$
|
(7,069)
|
|
$
|
(22,979)
|
|
$
|
(45,348)
|
________________________________
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
While Viatris, Inc. records the total
YUPELRI net sales, the Company is entitled to a 35% share of the
net profit (loss) pursuant to a co-promotion agreement with Viatris
as presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
(In thousands)
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
YUPELRI net sales (100%
recorded by Viatris)
|
|
$
|
58,325
|
|
$
|
53,423
|
|
$
|
160,318
|
|
$
|
146,166
|
YUPELRI net sales
(Theravance Biopharma implied 35%)
|
|
|
20,414
|
|
|
18,698
|
|
|
56,111
|
|
|
51,158
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2)
Amounts include share-based compensation
expense as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
(In thousands)
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Research and
development
|
|
$
|
2,004
|
|
$
|
2,623
|
|
$
|
6,301
|
|
$
|
10,062
|
Selling, general and
administrative
|
|
|
4,258
|
|
|
5,196
|
|
|
12,890
|
|
|
15,724
|
Restructuring and
related expenses
|
|
|
-
|
|
|
711
|
|
|
356
|
|
|
6,998
|
Total share-based
compensation expense
|
|
$
|
6,262
|
|
$
|
8,530
|
|
$
|
19,547
|
|
$
|
32,784
|
|
|
|
|
|
|
|
|
|
|
|
|
|
THERAVANCE
BIOPHARMA, INC.
|
Reconciliation of
GAAP to Non-GAAP Net Loss from Continuing Operations
|
(In
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
|
(Unaudited)
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss from
continuing operations
|
|
$
|
(8,950)
|
|
$
|
(16,023)
|
|
$
|
(46,683)
|
|
$
|
(78,568)
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based
compensation expense
|
|
|
6,262
|
|
|
8,530
|
|
|
19,547
|
|
|
32,784
|
Non-cash interest
expense
|
|
|
609
|
|
|
424
|
|
|
1,727
|
|
|
424
|
Income tax expense
(benefit)
|
|
|
1,367
|
|
|
-
|
|
|
2,430
|
|
|
12
|
Non-GAAP net loss
from continuing operations
|
|
$
|
(712)
|
|
$
|
(7,069)
|
|
$
|
(22,979)
|
|
$
|
(45,348)
|
View original content to download
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SOURCE THERAVANCE BIOPHARMA US, INC.