- Q2 2024 YUPELRI® (revefenacin) net sales of
$54.5 million, recognized by Viatris,
decreased 1% from Q2 20231
- Viatris collaboration revenue of $14.3 million, increased 4% versus Q2
2023
- Partner Viatris submitted YUPELRI NDA in China; $7.5
million milestone if approved
- Now expecting last patient into the open label portion of
CYPRESS in mid-2025, top line data anticipated approximately 6
months later
- Q2 2024 TRELEGY net sales of $1.065
billion, increasing the likelihood of achieving up to
$50 million of milestones in
2024
- Q2 2024 ending cash balance of $96.1
million
DUBLIN, Aug. 5, 2024
/PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma"
or the "Company") (NASDAQ: TBPH) today announced financial and
operational results for the second quarter of 2024.
![Theravance Biopharma Logo (PRNewsfoto/Theravance Biopharma, Inc.) Theravance Biopharma Logo (PRNewsfoto/Theravance Biopharma, Inc.)](https://mma.prnewswire.com/media/557290/Theravance_Biopharma_Logo.jpg)
"YUPELRI net sales decreased 1% from the prior quarter, owing
to near-term headwinds from an evolved channel mix and a lower
realized net price," said Rick
Winningham, Theravance Biopharma CEO. "We are disappointed
with this quarter's net sales result, but remain confident in our
ability to continue to grow YUPELRI in the future, given strong and
consistent demand generation." He continued, "In addition, while we
have activated over 80% of study sites in CYPRESS and achieved
solid enrollment in the quarter, we now anticipate enrolling the
last patient into the open-label portion of the study in mid-2025.
We continue to prioritize delivering a high-quality study in
pursuit of making ampreloxetine available to those MSA patients
suffering without viable treatment options for their symptomatic
nOH. Finally, we are pleased with another exceptional quarter for
TRELEGY, which increases our confidence in achieving milestones in
2024, which would contribute to our existing balance sheet
strength."
Second 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):
- Realized total net sales of $54.5
million for the quarter, a decrease of 1% compared with the
same period in 2023.1
- Generated a robust 13% increase in customer demand (Q2 2024 vs
Q2 2023).2
- Increased hospital doses sold by 43% (Q2 2024 vs Q2
2023).3
- Increased share of the long-acting nebulized segment of the
COPD market, with hospital share surpassing 18% and community share
reaching 32%, both all-time highs.4
- Granted an additional method of use patent for YUPELRI on
July 30, 2024, with an expiration
date of August 2039. Listed in the
FDA Orange Book.
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):
- Achieved steady progress in CYPRESS enrollment, with over 80%
of planned sites now activated, including a number of global
academic institutions, tertiary care centers and MSA Centers of
Excellence.
- Updated anticipated completion of enrollment into the
open-label portion of the study to mid-2025. Target completion
impacted by lengthier timelines to site activation, and to ensure
sufficient patients progress to the randomized withdrawal portion
of the study.
- Top line data anticipated to be available approximately 6
months after enrollment is completed in the open label portion of
the study.
TRELEGY Update:
- GSK posted second quarter 2024 global net sales of
approximately $1.1 billion (up 40%
from $760 million reported in the
second quarter of 2023), bringing year-to-date TRELEGY global net
sales to approximately $1.8 billion
(up 37% from the same period in 2023).
- As of June 30, 2024, Theravance
Biopharma is eligible to receive a total of $200 million in milestone payments from Royalty
Pharma, should TRELEGY achieve certain sales thresholds. The next
milestone payment of $25 million will
be achieved if TRELEGY global net sales reach approximately
$2.9 billion in 2024 (requiring
second half 2024 sales of approximately $1.1
billion), and a second $25
million milestone payment (for a total of $50 million) will be achieved if TRELEGY global
net sales exceed approximately $3.2
billion in 2024 (requiring second half 2024 sales of
approximately $1.4 billion).
Second Quarter Financial Results
- Revenue: Total revenue for the second quarter of 2024
was $14.3 million, consisting
entirely of Viatris collaboration revenue. Viatris collaboration
revenue increased by $0.5 million, or
4%, in the second quarter compared to the same period in 2023 due
primarily to 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 second quarter of 2024 was $19.1 million which represented a 1% decrease
compared to the same period in 2023.
- Research and Development (R&D) Expenses: R&D
expenses for the second quarter of 2024 were $10.0 million, compared to $9.4 million in the same period in 2023. Second
quarter R&D expenses included total non-cash share-based
compensation of $1.2 million.
- Selling, General and Administrative (SG&A) Expenses:
SG&A expenses for the second quarter of 2024 were $17.1 million, compared to $19.3 million in the same period in 2023. Second
quarter SG&A expenses included total non-cash share-based
compensation of $4.2 million.
- Non-Cash Impairment of Long-Lived Assets: As the
R&D lab space leasing market in South San Francisco continued
to soften in the second quarter, the Company incurred a non-cash
impairment charge of $3.0 million on
its long-lived assets (consisting primarily of its operating
leases) in the second quarter of 2024.
- Share-Based Compensation: Share-based compensation
expenses for the second quarter of 2024 was $5.4 million, compared to $6.3 million in the same period in 2023.
Share-based compensation expenses consisted of $1.2 million for R&D and $4.2 million for SG&A in the second quarter
of 2024, compared to $1.9 million and
$4.4 million, respectively, in the
same period in 2023.
- Net Loss and Non-GAAP Net Loss from
Operations5: Net loss was $16.5 million in the second quarter of 2024
compared to $15.6 million in the same
period in 2023. The net loss in the second quarter of 2024 was
impacted by the $3.0 million non-cash
impairment charge on the Company's long-lived assets. Non-GAAP net
loss from operations was $6.3 million
in the second quarter 2024 compared to a non-GAAP net loss from
operations of $7.4 million in the
same period in 2023. See the section titled "Non-GAAP Financial
Measures" for more information.
- Cash Position: Cash, cash equivalents and marketable
securities totaled $96.1 million as
of June 30, 2024.
Updated 2024 Financial Guidance
- Operating Expenses (excluding share-based
compensation): The Company continues to expect full year
2024 R&D expenses of $30 million
to $36 million and SG&A expenses
of $45 million to $55 million, in each case excluding share-based
compensation.
- Share-Based Compensation: The Company continues to
expect full year share-based compensation expenses of $18 million to $22
million.
- Non-GAAP Net Profit / Loss: The Company now expects
levels of both non-GAAP losses and cash burn to be similar to first
half actuals 2024.
Corporate Initiatives to Maximize Shareholder Value
Pursuant to a recently-completed review of its substantial Irish
tax assets, the Company is engaging tax and financial advisors to
explore opportunities through which to unlock value, given the gap
between our share price and the value of our diverse and unique
portfolio, including YUPELRI, ampreloxetine, TRELEGY and the
Company's tax assets. We will provide further updates as
appropriate.
Intellectual Property Updates
Patent Infringement Suits
Patent litigation is pending
against four companies, along with certain affiliates; we
previously disclosed litigation involving three of these companies.
In June 2024, the Company filed a
patent infringement suit in the U.S. District Court for the Eastern
District of Pennsylvania against a
subsequent filer of an abbreviated new drug application (ANDA) for
a generic version of YUPELRI. As a result of this lawsuit, a
30-month stay of approval through November
2026 would be expected to be automatically granted by the
FDA on the subsequent filer's ANDA pending any adverse court
decision. As of July 31, 2024, the
Company has settled litigation with four companies pursuant to
individual agreements in which we granted these companies a
royalty-free, non-exclusive, non-sublicensable, non-transferable
license to manufacture and market their respective generic versions
of YUPELRI inhalation solution in the US on or after the licensed
launch date of April 23, 2039,
subject to certain exceptions as is customary in these type of
agreements. As required by law, the settlements are subject to
review by the U.S. Department of Justice and the Federal Trade
Commission.
Additional Patent
An additional method of use patent
for YUPELRI was granted on July 30,
2024, which expires in August
2039, and is listed in the FDA Orange Book.
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 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, Events and Presentations.
A replay of the webcast will be available on Theravance
Biopharma's website for 30 days through September 4, 2024.
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. In the US, the Company has
been granted an Orphan Drug Designation for ampreloxetine for the
treatment of symptomatic nOH in patients with MSA and, if results
from the ongoing Phase 3 CYPRESS study are supportive, plans to
file an NDA for full approval in this indication.
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).6 There are approximately 50,000 MSA
patients in the US7 and 70-90% of MSA patients
experience nOH symptoms.8 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 once-daily norepinephrine reuptake inhibitor in
development for symptomatic neurogenic orthostatic hypotension
(nOH) in patients with Multiple System Atrophy (MSA), has the
potential to be a first in class therapy effective in treating a
constellation of cardinal symptoms in MSA 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 in 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
expectations regarding its future profitability, expenses and uses
of cash, the Company's goals, designs, strategies, plans and
objectives, future growth of YUPELRI sales, future royalty
payments, 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, the status of patent infringement litigation initiated by
the Company and its partner against certain generic companies in
federal district courts; contingent payments due to the Company
from the sale of the Company's TRELEGY ELLIPTA royalty interests to
Royalty Pharma, and expectations around the use of OHSA scores
as endpoints for clinical trials. 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: factors that could increase the Company's
cash requirements or expenses beyond its expectations and any
factors that could adversely affect its profitability, 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, 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 May 15, 2024, 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
profit (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 continuing
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.
Please see the appendix attached to this press release for a
reconciliation of non-GAAP net profit (loss) from operations to its
corresponding measure, net profit (loss) from operations. A
reconciliation of non-GAAP net profit (loss) from operations to its
corresponding GAAP measure is not available on a forward-looking
basis without unreasonable effort due to the uncertainty regarding,
and the potential variability of, expenses and other factors in the
future.
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 Source: Viatris Customer Demand (Q2'24).
3 Source: IQVIA DDD, HDS, VA and Non-Reporting
Hospital through Jun '24.
4 Hospital LA-NEB Market Share - IQVIA DDD through
Jun '24. Community LA-NEB Market Share includes Retail + DME /
Med B FFS through May '24.
5 Non-GAAP profit (loss) consists of GAAP net income
(loss) before taxes less share-based compensation expense, non-cash
interest expense, and non-cash impairment expense. See the section
titled "Non-GAAP Financial Measures" for more information.
6 https://medlineplus.gov/genetics/condition/multiple-system-atrophy/
7 UCSD Neurological Institute (25K-75K, with ~10K new
cases per year); NIH National Institute of Neurological Disorders
and Stroke (15K-50K).
8 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)
|
|
|
|
|
|
|
|
June
30,
|
|
December
31,
|
|
2024
|
|
2023
|
Assets
|
(Unaudited)
|
|
(1)
|
Current
assets:
|
|
|
|
Cash and cash
equivalents and short-term marketable securities
|
$
|
96,078
|
|
$
|
102,426
|
Receivables from
collaborative arrangements
|
|
14,299
|
|
|
17,474
|
Prepaid clinical and
development services
|
|
2,646
|
|
|
2,038
|
Other prepaid and
current assets
|
|
6,284
|
|
|
11,603
|
Total current
assets
|
|
119,307
|
|
|
133,541
|
Property and equipment,
net
|
|
8,142
|
|
|
9,068
|
Operating lease
assets
|
|
31,815
|
|
|
36,287
|
Future contingent
milestone and royalty assets
|
|
194,200
|
|
|
194,200
|
Restricted
cash
|
|
836
|
|
|
836
|
Other assets
|
|
7,729
|
|
|
8,067
|
Total
assets
|
$
|
362,029
|
|
$
|
381,999
|
|
|
|
|
|
|
Liabilities and
Shareholders' Equity
|
|
|
|
|
|
Current
liabilities
|
$
|
22,946
|
|
$
|
24,767
|
Long-term operating
lease liabilities
|
|
42,441
|
|
|
45,236
|
Future royalty payment
contingency
|
|
29,061
|
|
|
27,788
|
Unrecognized tax
benefits
|
|
69,007
|
|
|
65,294
|
Other long-term
liabilities
|
|
4,885
|
|
|
5,919
|
Shareholders'
equity
|
|
193,689
|
|
|
212,995
|
Total liabilities and
shareholders' equity
|
$
|
362,029
|
|
$
|
381,999
|
|
|
|
|
|
|
________________________________
|
|
|
|
|
|
|
|
|
|
|
|
(1)
The condensed consolidated balance sheet as of December 31, 2023
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, 2023.
|
THERAVANCE
BIOPHARMA, INC.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(In thousands,
except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
2024
|
|
2023
|
|
2024
|
|
2023
|
|
|
(Unaudited)
|
|
(Unaudited)
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
Viatris collaboration
agreement (1)
|
|
$
|
14,256
|
|
$
|
13,743
|
|
$
|
28,759
|
|
$
|
24,154
|
Collaboration
revenue
|
|
|
-
|
|
|
6
|
|
|
-
|
|
|
12
|
Total
revenue
|
|
|
14,256
|
|
|
13,749
|
|
|
28,759
|
|
|
24,166
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development (2)
|
|
|
9,954
|
|
|
9,425
|
|
|
18,922
|
|
|
23,997
|
Selling,
general and administrative (2)
|
|
|
17,056
|
|
|
19,278
|
|
|
33,798
|
|
|
38,461
|
Impairment
of long-lived assets (non-cash)
|
|
|
2,951
|
|
|
-
|
|
|
2,951
|
|
|
-
|
Restructuring and related expenses (2)
|
|
|
-
|
|
|
1,169
|
|
|
-
|
|
|
2,743
|
Total
costs and expenses
|
|
|
29,961
|
|
|
29,872
|
|
|
55,671
|
|
|
65,201
|
Loss from
operations
|
|
|
(15,705)
|
|
|
(16,123)
|
|
|
(26,912)
|
|
|
(41,035)
|
Interest expense
(non-cash)
|
|
|
(644)
|
|
|
(568)
|
|
|
(1,273)
|
|
|
(1,118)
|
Interest income and
other income (expense), net
|
|
|
1,128
|
|
|
2,504
|
|
|
2,562
|
|
|
5,483
|
Loss before income
taxes
|
|
|
(15,221)
|
|
|
(14,187)
|
|
|
(25,623)
|
|
|
(36,670)
|
Provision for income
tax expense
|
|
|
(1,308)
|
|
|
(1,458)
|
|
|
(2,570)
|
|
|
(1,063)
|
Net
loss
|
|
$
|
(16,529)
|
|
$
|
(15,645)
|
|
$
|
(28,193)
|
|
$
|
(37,733)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
$
|
(0.34)
|
|
$
|
(0.28)
|
|
$
|
(0.58)
|
|
$
|
(0.63)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute
basic and diluted net loss per share
|
|
|
48,747
|
|
|
56,682
|
|
|
48,515
|
|
|
59,791
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net
loss
|
|
$
|
(6,250)
|
|
$
|
(7,355)
|
|
$
|
(10,795)
|
|
$
|
(22,267)
|
________________________________
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(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
June 30,
|
|
Six Months Ended
June 30,
|
(In thousands)
|
|
2024
|
|
2023
|
|
2024
|
|
2023
|
YUPELRI net sales (100%
recorded by Viatris)
|
|
$
|
54,530
|
|
$
|
55,038
|
|
$
|
109,756
|
|
$
|
101,993
|
YUPELRI net sales
(Theravance Biopharma implied 35%)
|
|
|
19,085
|
|
|
19,263
|
|
|
38,415
|
|
|
35,697
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2) Amounts
include share-based compensation expense as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
(In thousands)
|
|
2024
|
|
2023
|
|
2024
|
|
2023
|
Research and
development
|
|
$
|
1,151
|
|
$
|
1,855
|
|
$
|
2,616
|
|
$
|
4,296
|
Selling, general and
administrative
|
|
|
4,225
|
|
|
4,409
|
|
|
7,988
|
|
|
8,632
|
Restructuring and
related expenses
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
357
|
Total share-based
compensation expense
|
|
$
|
5,376
|
|
$
|
6,264
|
|
$
|
10,604
|
|
$
|
13,285
|
THERAVANCE
BIOPHARMA, INC.
|
Reconciliation of
GAAP to Non-GAAP Net Loss
|
(In
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
2024
|
|
2023
|
|
2024
|
|
2023
|
|
|
(Unaudited)
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net
loss
|
|
$
|
(16,529)
|
|
$
|
(15,645)
|
|
$
|
(28,193)
|
|
$
|
(37,733)
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based
compensation expense
|
|
|
5,376
|
|
|
6,264
|
|
|
10,604
|
|
|
13,285
|
Non-cash impairment of
long-lived assets
|
|
|
2,951
|
|
|
-
|
|
|
2,951
|
|
|
-
|
Non-cash interest
expense
|
|
|
644
|
|
|
568
|
|
|
1,273
|
|
|
1,118
|
Income tax
expense
|
|
|
1,308
|
|
|
1,458
|
|
|
2,570
|
|
|
1,063
|
Non-GAAP net
loss
|
|
$
|
(6,250)
|
|
$
|
(7,355)
|
|
$
|
(10,795)
|
|
$
|
(22,267)
|
View original content to download
multimedia:https://www.prnewswire.com/news-releases/theravance-biopharma-inc-reports-second-quarter-2024-financial-results-and-provides-business-update-302214718.html
SOURCE Theravance Biopharma, Inc.