Full Press Release Details
Theravance Biopharma, Inc. Reports First
Quarter 2020 Financial Results and Provides Business Update
IRELAND - May 6, 2020 - Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company")
(NASDAQ: TBPH) today reported financial results for the first quarter ended March 31, 2020. Revenue for the first quarter 2020
was $19.9 million. Operating loss was $72.5 million, or $57.2 million excluding share-based compensation expense. Cash, cash equivalents
and marketable securities totaled $492.1 million as of March 31, 2020.
"As we are each challenged by COVID-19
- personally and professionally, I want to thank our employees who have supported the communities we serve: the most vulnerable
with respiratory illness and immune deficiencies, healthcare professionals across the globe and each other in extremely troublesome
times. I could not be prouder, " said Rick E Winningham, Chief Executive Officer: "Theravance Biopharma moved to remote
working conditions in early March 2020 for the vast majority of our workforce. Our past investment in technology infrastructure
is enabling us to rapidly shift and service our business. Our geographic diversification of clinical trial sites as well as supply
chain is minimizing impact on our clinical trial programs. The commitment of our lab-based personnel to work in our laboratories
during this time has been crucial to continued progress of our pipeline programs."
"Our commercial team remains focused on delivering YUPELRI
to the COPD community - always a vulnerable community and especially during this pandemic - to both the people with
COPD and the healthcare professionals that treat them; our team has been continuously available to support them with YUPELRI. As
the only once-daily nebulized maintenance therapy for COPD, we believe YUPELRI has made a difference for the community during these
"We are well-capitalized to
continue our pipeline momentum. We have significantly accelerated internal research and development efforts on TD-0903, a
lung-selective nebulized JAKi with the potential 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. The
learnings from the early clinical experience of TD-0903 will not only benefit the program in its potential for the treatment
of COVID-19 lung hyperinflammation but will inform the broader clinical program in other severe inflammatory conditions of
the lung. We are working in close collaboration with our partner, Janssen, on TD-1473, a gut-selective oral JAKi in
development for inflammatory intestinal disease and TD-5202, gut-selective irreversible JAK3 inhibitor in development for
inflammatory intestinal diseases. TD-8236, our lung-selective dry powder inhaler pan-JAK inhibitor in development for
inflammatory lung disease, continues to progress. Ampreloxetine, a norepinephrine reuptake inhibitor (NRI) is under
evaluation for treatment of symptomatic neurogenic orthostatic hypotension (nOH), a rare disease, in a Phase 3 clinical
program. We continue to move these programs forward despite the significant hurdles imposed by social distancing and
government lockdowns around the world."
"As we look ahead, as a company with a legacy in developing
respiratory medicines, we hope our inhaled JAK inhibitor program can help make a meaningful contribution to the COVID-19 story
as we continue to progress our other high priority programs of TD-1473 and ampreloxetine."
Corporate Highlights
Partnered with Mylan:
YUPELRI (revefenacin) inhalation solution (lung-selective
nebulized long-acting muscarinic antagonist (LAMA)):
Key Pipeline Progress
The COVID-19 pandemic is a significant
threat to public health throughout the world and the Company has been diligently monitoring and adapting to the threat. Theravance
Biopharma has been evaluating each of its clinical trial programs to determine necessary modifications and working closely with
regulators, ethics committees, sites, CROs and data safety monitoring boards. The Company appreciates the pragmatism, collaboration
and the ongoing prioritization of the clinical trial participants and all of those caring for them. Given the significant strains
on the healthcare system across the globe, Theravance Biopharma took the decision in mid-March to temporarily suspend adding new
patients to the screening phase for its TD-1473 and ampreloxetine trials for 4 weeks, in order to prioritize ongoing support for
patients who were already in screening and those patients who were already randomized. As a result, the studies were able to continue
randomizing existing screened patients into the studies and the randomized patients were able to continue to receive study medication
per the protocol requirements. Screening of new patients is now resuming in some countries in a controlled and measured fashion
as individual sites confirm their ability to support the study requirements and new patients are able to be assessed for their
eligibility to participate in the studies. The global nature of the TD-1473 and ampreloxetine clinical programs will allow for
flexibility as COVID-19 control measures evolve in different countries. The situation is expected to continue to change at different
rates in different countries around the world in response to COVID-19 interventions, and as a result it is not possible to provide
an accurate re-estimation of expected completion dates for these programs at this time outside of our guidance of shifting data
In light of the COVID-19 pandemic, the
Company is implementing mitigation plans to ensure patients in the clinical trials have continued access to drug supply and regular
visits with their physicians for study visits per trial protocols. The Company continues to develop strategies to reduce patient
needs to travel to sites in hopes of avoiding unnecessary exposure while balancing safety monitoring of investigational products.
The Company is working closely with regulators and Ethics Committees and taking steps to ensure protection of patients, site personnel
and clinical trial integrity.
Partnered with Janssen Biotech, Inc.:
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):
Ampreloxetine (TD-9855, norepinephrine
reuptake inhibitor (NRI) for symptomatic nOH):
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 ELLIPTA (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 ELLIPTA (the combination of fluticasone furoate, aclidinium, 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 LLC") 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.
First Quarter Financial Results
2020 Financial Guidance
as previously announced, the Company closed its public offering of 5,500,000 ordinary shares at a price to the public of $27.00
per share on February 14, 2020. The gross proceeds to Theravance Biopharma from the offering are approximately $148.5 million,
before deducting underwriting discounts and commissions and estimated offering expenses.
2020 Theravance Biopharma announced the closing of a private placement of $400 million in aggregate principal amount of non-recourse
9.5% fixed rate term notes. The notes are secured by a portion of the future payments the Company expects to receive related to
royalties due on net sales of TRELEGY ELLIPTA, with 75% of such payments to be used
to satisfy the debt obligations until the notes are repaid and the remaining 25% of such payments being directed to benefit the
Company on an ongoing basis. The Company used a portion of the net proceeds from this transaction to repay in full the remaining
outstanding balance of the $250 million Triple PhaRMASM 9.0% fixed rate term notes due 2033 and intends to use the remainder
of the net proceeds to support continued execution of its key development programs.
Conference Call and Live Webcast Today
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, and use the confirmation code 8371418. 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 June 5, 2020. An audio replay will also be available through
8:00 pm ET on May 13, 2020 by dialing (855) 859-2056 from the U.S., or (404) 537-3406 for international callers, and then entering
confirmation code 8371418.