Full Press Release Details
Theravance Biopharma, Inc. Reports Third
Quarter 2020 Financial Results and Provides Business Update
IRELAND - NOVEMBER 5, 2020 - Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company")
(NASDAQ: TBPH) today reported financial results for the third quarter ending September 30, 2020. Theravance Biopharma's Total
Revenue for the third quarter 2020 was $18.3 million. Operating loss was $76.6 million, or $61.1 million excluding share-based
compensation expense. Cash, cash equivalents and marketable securities totaled $358.3 million as of September 30, 2020.
In connection with the commercialization
of YUPELRI , the Company is entitled to a share of U.S. profits and losses (65% to Mylan; 35% to the Company) pursuant
to its agreement with Mylan. While Mylan records the total Net Sales of YUPELRI within its financial statements, Theravance Biopharma's
implied 35% share of net sales for YUPELRI during Q3 2020 was $13.0 million (up from $5.8 million in Q3 2019). Going forward, Theravance
Biopharma will report its implied 35% of Net Sales for YUPELRI in public communications and in the Company's quarterly SEC
filings on Form 10-Q and Form 10-K.
"YUPELRI gained market share, delivered
sales growth versus the second quarter and achieved brand profitability for Theravance Biopharma thanks to the efforts of the Mylan
and Theravance Biopharma commercial teams. Based on the constraints posed by the pandemic, the team implemented a hybrid model
of virtual selling, utilizing digital resources and in-person meetings when and where permitted, " said Rick E Winningham,
Chief Executive Officer.
"Despite ongoing challenges and the
uncertain environment created by the global pandemic, we have seen a significant uptick in clinical trial enrollment. We therefore
have more confidence in guiding to Phase 3 results for ampreloxetine for symptomatic neurogenic orthostatic hypotension (nOH) and
for TD-1473 Phase 2b results in ulcerative colitis and Phase 2 results in Crohn's disease in Q3 2021."
"We completed the TD-8236 Phase 1
Part C and Phase 2a Lung Allergen Challenge (LAC) study. The LAC study represented the first time an inhaled JAK inhibitor was
studied in such a model. We met our primary objectives with the Phase 1 Part C study in moderate-to-severe asthmatics dosing TD-8236
with an inhaled corticosteroid. Decreases in key inflammatory biomarkers were seen in the TD-8236 plus steroid arm versus the steroid
alone arm. Gene expression and cytokine data from the Phase 1 Part C is still under analysis. While we are still reviewing the
full data set, TD-8236 as a single agent did not meet the primary objective of the Phase 2a LAC study."
"In regard to TD-0903, we have had
a chance to review the Phase 1 data. Results showed favorable safety and tolerability profile across the full range of nebulized
doses and low systemic levels of TD-0903 in the systemic circulation, consistent with the lung-selective design. This has given
us confidence as we continue to dose patients in the Phase 2 COVID-19 trial, which is being conducted in multiple locations around
the world with results expected in Q2 2021."
Corporate Highlights
YUPELRI (revefenacin) inhalation solution
(lung-selective nebulized long-acting muscarinic antagonist (LAMA)):
Key Pipeline Progress
The COVID-19 pandemic has made it difficult to operate a business
in many ways and none more so than in clinical trials. Despite the challenges, Theravance Biopharma has been encouraged by the
response to our ongoing clinical trial recruitment efforts. By design, both ampreloxetine and TD-1473 clinical programs employ
geographical diversity, which has allowed the Company to continue to work closely with sites to continue enrollment where possible.
Ampreloxetine (TD-9855, norepinephrine reuptake inhibitor
(NRI) for symptomatic nOH):
TD-1473 (gut-selective oral pan-Janus kinase (JAK) inhibitor
for inflammatory intestinal diseases):
TD-5202 (gut-selective irreversible JAK3 inhibitor for inflammatory
intestinal diseases):
TD-8236 (lung-selective inhaled pan-JAK inhibitor for inflammatory
The collective data set (pre-clinical, Phase 1, Phase 2a) demonstrates
TD-8236 engages the JAK mechanism at a dose of 1500 g as evidenced by the reduction in FeNO and reductions in pSTAT. The
Company will continue to analyze the data set including the forthcoming gene expression and cytokine data from the Phase 1 Part
(nebulized lung-selective pan-JAK inhibitor for acute hyperinflammation of the lung in COVID-19 and chronic inflammation for the
prevention of lung transplant rejection):
For treatment of Acute Lung Injury caused by COVID-19
The ongoing effects of the COVID-19 pandemic present a substantial
public health and economic challenge, affecting our employees, patients, communities, clinical trial sites, suppliers, business
partners and business operations. The full extent to which the COVID-19 pandemic will continue to directly or indirectly impact
our business will depend on future developments that are highly uncertain, including the ongoing spread of the virus globally,
and the actions taken to contain or treat it.
TRELEGY (first once-daily single inhaler
triple therapy for COPD)1:
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, 25% of income from the Company's investment in TRC is retained by the Company.
Innoviva and Theravance Respiratory Company
On June 10, 2020, the Company disclosed in a Form 8-K that it
had formally objected to Theravance Respiratory Company, LLC ("TRC") and Innoviva, as the manager of TRC, regarding
their proposed plan to use TRELEGY royalties to invest in certain privately-held companies, funds that would otherwise be available
for distribution to the Company under the terms of the TRC LLC Agreement. The Company intends to continue to seek to protect its
interests in this matter consistent with the dispute resolution procedures of the TRC LLC Agreement. In this regard, the Company
initiated an arbitration proceeding against Innoviva and TRC in October 2020 challenging the authority of Innoviva and TRC to pursue
such a business plan rather than distribute such funds to the Company in a manner consistent with the LLC Agreement and the Company's
85% economic interest in TRC. An arbitration hearing is scheduled for the first quarter of 2021.
Third Quarter Financial Results
2020 Financial Guidance
The Company will hold
its 2021 Annual General Meeting on April 27, 2021.
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 GMT. 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 1269525. 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.
A replay of the conference call will be
available on Theravance Biopharma's website for 30 days through December 5, 2020. An audio replay will also be available
through 8:00 pm ET on November 12, 2020 by dialing (855) 859-2056 from the U.S., or (404) 537-3406 for international callers, and
then entering confirmation code 1269525.
About Theravance Biopharma
Theravance Biopharma, Inc. is a diversified
biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines. Our
purpose is to create transformational medicines to improve the lives of patients suffering from serious illnesses. Our research
is focused in the areas of inflammation and immunology.
In pursuit of our purpose, we apply insights
and innovation at each stage of our business and utilize our internal capabilities and those of partners around the world. We apply
organ-selective expertise to biologically compelling targets to discover and develop medicines designed to treat underserved localized
diseases and to limit systemic exposure, in order to maximize patient benefit and minimize risk. 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