DUBLIN, Feb. 27, 2017 /PRNewswire/ -- Theravance
Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" or the
"Company") today reported financial results for the fourth quarter
and full year ended December 31,
2016. Revenue for the fourth quarter and full year of 2016
was $5.7 million and $48.6 million, respectively. Full year 2016
operating loss was $180.5 million.
Full year operating loss excluding share-based compensation was
$139.3 million, in line with the
Company's previously stated guidance of approximately $140 million. Cash, cash equivalents, and
marketable securities totaled $592.7
million as of December 31,
2016.
Rick E Winningham, Chairman and Chief Executive Officer,
commented: "2016 was a year of significant progress for Theravance
Biopharma. We made important clinical gains in multiple programs,
including advancements for our JAK inhibitor program in ulcerative
colitis and our Phase 3 revefenacin program in COPD, as well as in
two of our mid-stage assets – TD-9855 in neurogenic orthostatic
hypotension (nOH) and velusetrag in gastroparesis. We continued to
focus on executing our commercial and label expansion strategies
for VIBATIV®, and reported positive data from our TOUR™
study. We significantly strengthened our cash reserves, positioning
us to drive key programs through important value inflection
points.
"We are focused on continuing our momentum from 2016, and we
have an extensive line up of milestones anticipated in 2017 and
2018. We believe the programs we are pursuing will provide valuable
and differentiated therapeutic options for patients with unmet
needs. With our pipeline of proprietary and partnered assets,
combined with our economic interest in the GSK closed triple
program and strong balance sheet, we believe we are well-positioned
to generate significant value for patients and shareholders in the
near- and long-term."
Pipeline Update and Recent Highlights
- Intestinally Restricted Pan-Janus Kinase (JAK) Inhibitor
Program for Ulcerative Colitis and Other Inflammatory Bowel
Diseases:
- TD-1473: Enrollment underway in a Phase 1b trial in patients
with moderate to severe ulcerative colitis, following results of
the Phase 1 single ascending dose (SAD) and multiple ascending dose
(MAD) studies in healthy volunteers demonstrating favorable
tolerability and minimal systemic exposure.
- Advancing Mid-Stage Assets: TD-9855 and Velusetrag
- TD-9855 (dual norepinephrine and serotonin reuptake inhibitor
(NSRI)): Enrollment underway in a Phase 2a study in patients with
nOH; the study protocol is being amended to allow patients who
respond to continue beyond a single dose.
- Velusetrag (5-HT4 agonist): Enrollment recently completed in
the Phase 2b study in idiopathic and diabetic gastroparesis
patients; Fast Track designation granted by US Food and Drug
Administration (FDA) in Q4 2016.
- Neprilysin (NEP) Inhibitor Program for Cardiovascular and Renal
Diseases:
- TD-0714: Results announced from a Phase 1 MAD study in healthy
volunteers in Q4 2016. Phase 1 program complete and results
supportive of further compound development.
- TD-1439: Phase 1 SAD study in healthy volunteers completed in
Q1 2017. Results support program objectives, with TD-1439
demonstrating sustained 24-hour target engagement, low levels of
renal elimination and a favorable tolerability profile.
- Revefenacin (TD-4208) Program: Once-Daily Nebulized Long-Acting
Muscarinic Antagonist (LAMA) for Chronic Obstructive Pulmonary
Disease (COPD); partnered with Mylan:
- Results announced in two pivotal three-month Phase 3 efficacy
studies in patients with COPD in Q4 2016. Both studies met their
primary endpoint, demonstrating statistically significant and
clinically meaningful improvements in trough lung function after 12
weeks of dosing revefenacin, both in patients who had no other COPD
medications and in those who were also using background COPD
treatments (including LABA and LABA/ICS). Revefenacin was also
shown to be generally well-tolerated at both doses studied (88 mcg
and 175 mcg).
- Preparing to initiate a Phase 3b study of revefenacin in
patients with low peak inspiratory flow rate (PIFR), designed to
support commercialization.
- VIBATIV® (telavancin):
- For the full year, U.S. net product sales of VIBATIV increased
100% to $17.6 million.
- Enrollment complete in the Telavancin Observational Use
Registry (TOURTM) study in Q1 2017. Initial data show
positive clinical responses in patients with bacteremia,
endocarditis, osteomyelitis, skin and respiratory infections.
- Closed Triple (the combination of fluticasone furoate,
umeclidinium, and vilanterol)1:
- Regulatory filings complete in the US and EU for COPD, and
Phase 3 CAPTAIN trial in asthma initiated, all in Q4 2016.
Expected Upcoming Milestones
- TD-1439 (NEP inhibitor): Completion of the Phase 1 MAD study in
healthy volunteers in 1H 2017.
- TD-1473 (JAK inhibitor): Data from the Phase 1b study in
patients with ulcerative colitis in mid-2017.
- TD-3504 (JAK inhibitor): Initiation of a Phase 1 study expected
in 1H 2017.
- Velusetrag (TD-5108): Completion of the Phase 2b study in
patients with gastroparesis in mid-2017.
- TD-9855 (NSRI): Data from a Phase 2a study in patients with nOH
in 2017.
- Revefenacin (TD-4208): Completion of the 12-month Phase 3
safety study in patients with COPD in mid-2017; potential NDA
filing in late 2017; completion of the Phase 3b PIFR study in early
2018; potential regulatory approval in the US for COPD in
2018.
- VIBATIV: TOURTM study data to be published
throughout 2017; completion of the Phase 3 registrational
bacteremia study in 2018, to be followed by potential sNDA
submission in the US for bacteremia.
- Closed Triple1: Completion of the Phase 3
IMPACT study in 2017; potential regulatory approval in the US and
EU for COPD in late 2017; Phase 3 CAPTAIN study completion in
asthma patients and supplementary regulatory submissions for asthma
in 2018.
Notes:
1As reported by Glaxo
Group Limited or one of its affiliates (GSK)
Fourth Quarter Financial Results
Revenue
Revenue for the fourth quarter of 2016 was $5.7 million, primarily related to U.S. net
product sales of VIBATIV® of $5.0
million. This represents an increase of $1.9 million over the same period in 2015.
Full year 2016 revenue was $48.6
million, comprised of $31.0
million in revenue from collaborative arrangements and U.S.
net product sales of VIBATIV® of $17.6 million.
Research and Development (R&D) Expenses
R&D expenses for the fourth quarter of 2016 were
$42.0 million representing an
increase of $9.6 million compared to
the same period in 2015. The increase is primarily attributed to
costs associated with the progression of our priority programs.
Full year R&D expenses were $141.7
million, or $121.5 million
excluding share-based compensation.
Selling, General and Administrative (SG&A) Expenses
SG&A expenses for the fourth quarter were $20.4 million, representing a decrease of
$3.7 million compared to the same
period in 2015. The decrease is driven by lower costs associated
with share-based compensation and lower external sales and
marketing expenses. Full year SG&A expenses were $84.5 million, or $63.5
million excluding shared-based compensation expense.
Cash, Cash Equivalents and Marketable Securities
Cash and cash equivalents, and marketable securities totaled
$592.7 million as of December 31, 2016, an increase of $377.4 million as compared to December 31, 2015. The increase is
primarily due to net proceeds received by the Company related to
financing activities completed in 2016, offset by funds used in
operations.
2017 Financial Guidance
We expect to fund advancements across all stages of our
development pipeline, including investment towards the key program
milestones anticipated in 2017 and 2018. We anticipate our full
year 2017 operating loss, excluding share-based compensation, will
be in the range of $195.0 to $205.0
million. The actual amount could be above or below this
forecast as a result of a variety of factors impacting our
business, including business development transactions, the timing
and cost of clinical and non-clinical studies associated with our
priority programs, and net product sales of
VIBATIV®.
Conference Call Today at 5:00 pm
ET
Theravance Biopharma will hold a conference call today at
5:00 pm ET. To participate in the
live call by telephone, please dial (855) 296-9648 from the U.S.,
or (920) 663-6266 for international callers, using the confirmation
code 56971538. 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 Investor Relations
section, Presentations and Events. Please go to the website 15
minutes prior to the start of the call to register, download, and
install any necessary audio software.
A replay of the conference call will be available on Theravance
Biopharma's website for 30 days through March 29, 2017. An audio replay will also be
available through 8:00 pm ET on
March 6, 2017 by dialing (855)
859-2056 from the U.S., or (404) 537-3406 for international
callers, and then entering confirmation code 56971538.
About Theravance Biopharma
Theravance Biopharma is a diversified biopharmaceutical company
with the core purpose of creating medicines that help improve the
lives of patients suffering from serious illness.
Our pipeline of internally discovered product candidates
includes potential best-in-class medicines to address the unmet
needs of patients being treated for serious conditions primarily in
the acute care setting. VIBATIV® (telavancin), our first
commercial product, is a once-daily dual-mechanism antibiotic
approved in the U.S., Europe and
certain other countries for certain difficult-to-treat infections.
Revefenacin (TD-4208) is a long-acting muscarinic antagonist (LAMA)
being developed as a potential once-daily, nebulized treatment for
chronic obstructive pulmonary disease (COPD). Our neprilysin (NEP)
inhibitor program is designed to develop selective NEP inhibitors
for the treatment of a range of major cardiovascular and renal
diseases, including acute and chronic heart failure, hypertension
and chronic kidney diseases, such as diabetic nephropathy. Our
research efforts are focused in the areas of inflammation and
immunology, with the goal of designing medicines that provide
targeted drug delivery to tissues in the lung and gastrointestinal
tract in order to maximize patient benefit and minimize risk. The
first program to emerge from this research is designed to develop
intestinally restricted-targeted pan-Janus kinase (JAK) inhibitors
for the treatment of a range of inflammatory intestinal
diseases.
In addition, we have an economic interest in future payments
that may be made by Glaxo Group Limited or one of its affiliates
(GSK) pursuant to its agreements with Innoviva, Inc. relating to
certain drug development programs, including the Closed Triple (the
combination of fluticasone furoate, umeclidinium, and vilanterol),
currently in development for the treatment of COPD and asthma.
For more information, please visit www.theravance.com.
THERAVANCE®, the Cross/Star logo, and
VIBATIV® are registered trademarks of the Theravance
Biopharma group of companies. Trademarks, trade names or service
marks of other companies appearing on this press release are the
property of their respective owners.
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 strategies, plans and
objectives, the timing of clinical studies and the timing of
announcement of data or results from clinical studies, the
potential benefits and mechanisms of action of the Company's
product and product candidates, the Company's expectations for
product candidates through development, potential regulatory
approval and commercialization (including their potential as
components of combination therapies), product sales and the
Company's expectations for its 2017 operating loss, excluding
share-based compensation. 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: delays or difficulties in commencing or
completing clinical studies, variability in rates of enrollment and
associated spending for planned or ongoing clinical studies, the
potential that results from clinical or non-clinical studies
indicate the Company's product candidates are unsafe or ineffective
(including when our product candidates are studied in combination
with other compounds), the feasibility of undertaking future
clinical trials for our product candidates based on FDA policies
and feedback, 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, risks associated with establishing and
maintaining sales, marketing and distribution capabilities with
appropriate technical expertise and supporting infrastructure, and
risks of developing an institutional customer mix for
VIBATIV® (telavancin) that meet the Company's plan for
the product. Other risks affecting Theravance Biopharma are
described under the heading "Risk Factors" contained in Theravance
Biopharma's Form 10-Q filed with the Securities and Exchange
Commission (SEC) on November 9, 2016.
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 Information:
Alexander Dobbin
Head of Investor Relations
650-808-4045
investor.relations@theravance.com
THERAVANCE
BIOPHARMA, INC.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(In thousands,
except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
December 31,
|
|
Year Ended
December 31,
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
(Unaudited)
|
|
(Unaudited)
|
|
(1)
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales
|
|
$
|
5,032
|
|
$
|
3,693
|
|
$
|
17,603
|
|
$
|
9,408
|
Revenue from
collaborative arrangements
|
|
|
660
|
|
|
200
|
|
|
31,045
|
|
|
32,718
|
Total
revenue
|
|
|
5,692
|
|
|
3,893
|
|
|
48,648
|
|
|
42,126
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
|
1,146
|
|
|
3,200
|
|
|
2,894
|
|
|
4,657
|
Research and
development (2)
|
|
|
42,013
|
|
|
32,403
|
|
|
141,712
|
|
|
129,165
|
Selling, general and
administrative (2)
|
|
|
20,366
|
|
|
24,064
|
|
|
84,509
|
|
|
90,203
|
Total costs and
expenses
|
|
|
63,526
|
|
|
59,667
|
|
|
229,115
|
|
|
224,025
|
Loss from
operations
|
|
|
(57,834)
|
|
|
(55,774)
|
|
|
(180,467)
|
|
|
(181,899)
|
Interest
expense
|
|
|
(185)
|
|
|
-
|
|
|
(1,404)
|
|
|
-
|
Interest and other
income
|
|
|
(745)
|
|
|
110
|
|
|
1,312
|
|
|
631
|
Loss before income
taxes
|
|
|
(58,764)
|
|
|
(55,664)
|
|
|
(180,559)
|
|
|
(181,268)
|
Provision for income
taxes
|
|
|
8,568
|
|
|
(10,836)
|
|
|
10,110
|
|
|
951
|
Net
loss
|
|
$
|
(67,332)
|
|
$
|
(44,828)
|
|
$
|
(190,669)
|
|
$
|
(182,219)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
$
|
(1.36)
|
|
$
|
(1.23)
|
|
$
|
(4.26)
|
|
$
|
(5.34)
|
Shares used to
compute basic and diluted net loss per share
|
|
|
49,570
|
|
|
36,513
|
|
|
44,711
|
|
|
34,150
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
The condensed consolidated
statement of operations for the year ended December 31, 2015 has
been derived from the audited consolidated financial statements
included in the Company's Annual Report on Form 10-K for the fiscal
year ended December 31, 2015.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2)
Amounts include share-based
compensation expense as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
December 31,
|
|
Year Ended
December 31,
|
(In thousands)
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Research and
development
|
|
$
|
5,150
|
|
$
|
5,437
|
|
$
|
20,202
|
|
$
|
25,770
|
Selling, general and
administrative
|
|
|
4,890
|
|
|
6,074
|
|
|
20,967
|
|
|
28,280
|
Total share-based
compensation expense
|
|
$
|
10,040
|
|
$
|
11,511
|
|
$
|
41,169
|
|
$
|
54,050
|
THERAVANCE
BIOPHARMA, INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(In
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December
31,
|
|
December
31,
|
|
2016
|
|
2015
|
Assets
|
(Unaudited)
|
|
(1)
|
Current
assets:
|
|
|
|
Cash and cash
equivalents and short-term marketable securities
|
$
|
501,096
|
|
$
|
172,434
|
Receivables from
collaborative arrangements (2)
|
|
9,076
|
|
|
35,232
|
Prepaid
taxes
|
|
3,060
|
|
|
12,764
|
Inventories
|
|
12,220
|
|
|
10,005
|
Other prepaid and
current assets
|
|
3,051
|
|
|
7,037
|
Property and
equipment, net
|
|
8,460
|
|
|
9,873
|
Long-term marketable
securities
|
|
91,565
|
|
|
42,860
|
Restricted
cash
|
|
833
|
|
|
833
|
Other
assets
|
|
9,893
|
|
|
9,078
|
Total
assets
|
$
|
639,254
|
|
$
|
300,116
|
|
|
|
|
|
|
Liabilities and
Shareholders' Equity
|
|
|
|
|
|
Current
liabilities
|
|
49,268
|
|
|
49,470
|
Long-term
liabilities
|
|
239,755
|
|
|
7,581
|
Shareholders'
equity
|
|
350,231
|
|
|
243,065
|
Total liabilities and
shareholders' equity
|
$
|
639,254
|
|
$
|
300,116
|
|
|
|
|
|
|
|
|
________________________________
|
|
|
(1)
The condensed consolidated balance sheet
at December 31, 2015 has been derived from the audited consolidated
financial statements included in the Company's Annual Report on
Form 10-K for the fiscal year ended December 31, 2015.
|
|
|
(2)
Receivables from collaborative
arrangements includes $7.8 million and $33.2 million in receivables
associated with the Mylan collaboration at December 31, 2016 and
2015, respectively.
|
|
|
To view the original version on PR Newswire,
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SOURCE Theravance Biopharma, Inc.