Full Press Release Details
Theravance Biopharma, Inc. Reports Second
Quarter 2020 Financial Results and Provides Business Update
IRELAND - AUGUST 6, 2020 - Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company")
(NASDAQ: TBPH) today reported financial results for the second quarter ending June 30, 2020. Revenue for the second quarter 2020
was $15.0 million. Operating loss was $72.2 million, or $55.6 million excluding share-based compensation expense. Cash, cash equivalents
and marketable securities totaled $438.3 million as of June 30, 2020.
"This quarter was the first quarter
for Theravance Biopharma working completely remotely, with the exception of our essential lab workers, and I could not be more
proud and grateful of the work the team has been able to deliver. We will continue to incorporate the key learnings into our processes
and will work to ensure that we become an even stronger company post-pandemic," said Rick E Winningham, Chief Executive Officer.
"Our commercial team continued to
find ways to sustain market share momentum with YUPLERI, coordinating meaningful interactions with their accounts by leveraging
digital and virtual selling tools. Given the challenges in a market which was and continues to be negatively affected by COVID-19,
we were able to improve YUPELRI market share. Moving into the third quarter, we are tailoring our sales model to a hybrid model
- in-person and remote call options - that can be modified depending on state and local restrictions, as well as customer
preference. This allows our field teams to customize their approach based on what's right for them and their customers, always
keeping health and safety the priority. We continue to forecast YUPELRI becoming a cash-flow positive brand in the United States
(US) by the end of 2020."
"We continue to move our clinical programs forward
despite ongoing challenges from the global pandemic. These challenges have resulted in delays in our late stage clinical
programs for ampreloxetine, a norepinephrine reuptake inhibitor (NRI) under evaluation for the treatment of symptomatic
neurogenic orthostatic hypotension (nOH), and TD-1473, a gut-selective oral JAKi in development for inflammatory intestinal
disease in Crohn's and ulcerative colitis. We continue to expect both programs to readout in 2021. Regarding TD-8236,
our lung-selective dry powder inhaled pan-JAK inhibitor in development for inflammatory lung disease, we expect to report
data from the asthma Phase 2 program in fourth quarter 2020."
"During the second quarter, the team leaned into our organizational
expertise in respiratory disease and moved our pre-clinical candidate TD-0903 into the clinic at an accelerated pace in response
to the COVID-19 pandemic. We designed TD-0903 to be a lung-selective nebulized JAKi with the intent of addressing lung hyperinflammation
in both the acute and chronic setting. In June, we completed Phase 1 and entered a Phase 2 study in the United Kingdom (UK) exploring
the potential of TD-0903 to treat hospitalized patients with Acute Lung Injury (ALI) caused by COVID-19 to prevent progression
to Acute Respiratory Distress Syndrome (ARDS) and the need for assisted ventilation. We are now opening additional sites in other
countries to accelerate TD-0903's progression in the clinic."
Corporate Highlights
YUPELRI (revefenacin) inhalation solution (lung-selective
nebulized long-acting muscarinic antagonist (LAMA)):
Key Pipeline Progress
The COVID-19 pandemic continues to be a threat to public
health throughout the world, however Theravance Biopharma is encouraged by the ability to initiate the reopening of clinical
sites for new patient screenings for ampreloxetine and TD-1473. The health and safety of the community Theravance Biopharma
serves is the Company's utmost priority; therefore, the Company is continuing to work closely with investigator sites and
vendors to help ensure their safety and that of the study participants as they contribute to our clinical programs. In
mid-March, both programs paused new patient screenings for four weeks to allow sites to focus on supporting patients who were
already in screening or already randomized and preserve data collection during this period. Screening of new patients resumed
in mid-April, and Theravance Biopharma has seen a significant percentage of sites reopen to new patients globally.
By design, both ampreloxetine and TD-1473 clinical programs
employ geographical diversity, which has allowed the Company to continue assessing where to reopen sites based on where the pandemic
is waning. That said, the pandemic shows no signs of stopping, and Theravance Biopharma expects ongoing challenges as new "hot
spots" emerge. We continue to expect both programs to readout in 2021.
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
TD-0903 (lung-selective nebulized pan-JAK inhibitor for treatment
of Acute Lung Injury caused by COVID-19)
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 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 Company's investment in TRC is pledged
to service outstanding notes, 25% of income from Company's investment in TRC is retained by Company.
Innoviva and Theravance Respiratory Company
we disclosed in a Form 8-K our objections to Theravance Respiratory Company, LLC ("TRC") and Innoviva, as the manager
of TRC, regarding TRC's proposed use of funds to invest in certain privately-held companies. On July 16, Innoviva and TRC
filed a complaint in Delaware Chancery Court seeking an order establishing that the arbitration award from the parties'
2019 dispute conclusively established that (a) Innoviva possesses the authority as Manager of TRC to cause TRC to make such investments
and (b) Innoviva possesses the authority as Manager of TRC to cause TRC to reserve cash to make such investments. The Court directed
the parties to refer certain relevant questions raised by the complaint to the arbitrator in the 2019 dispute, who in turn determined
that the 2019 proceedings did not resolve the issues currently in dispute. On August 5, Innoviva and TRC voluntarily dismissed
the complaint, without prejudice. We are pursuing and intend to continue to pursue the protection of the interests of the Company
in this matter consistent with the dispute resolution procedures of the TRC LLC Agreement, including, if necessary, the initiation
of a new arbitration proceeding.
Second Quarter Financial Results
2020 Financial Guidance
On June 22, 2020, GlaxoSmithKline plc (GSK) completed an
offering of $300 million of exchangeable senior notes due 2023; $280.3 million of which are exchangeable into existing
ordinary shares of Theravance Biopharma held by GSK. The notes are guaranteed by GSK and will be exchangeable at the option of
noteholders on any business day on or after September 1, 2020, under certain terms and conditions outlined in the offering
documents. The Company will not be issuing any new shares in connection with this offering, and the Company did
not receive any proceeds from the GSK offering.
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 2 pm PT / 9 pm GMT. To participate in the live call by telephone, please dial (855) 296-9648 from
the US or (920) 663-6266 for international callers, using the confirmation code 8098314. 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 September 5, 2020. An audio replay will also be available
through 8:00 pm ET on August 13, 2020 by dialing (855) 859-2056 from the US, or (404) 537-3406 for international callers, and then
entering confirmation code 8098314.
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