Theravance Biopharma, Inc. Reports First Quarter 2020 Financial Results and Provides Business Update
"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. "
"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 challenging times."
"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)):
- First and only once-daily, nebulized bronchodilator approved in the
U.S. for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), reimbursed by Part B Medicare program - Data as of
January 2020 show that YUPELRI achieved an 87% share of the nebulized LAMA market and a 13.7% share of the long-acting nebulized market (including Durable Medical Equipment) - YUPELRI is manufactured in
the United States and supply chains are monitored regularly; no disruption of supply is currently anticipated - In-person field calls on YUPELRI ceased as of
mid-March 2020 ; as with most pharmaceuticals, sales momentum has been affected by COVID-19; the team is leveraging established relationships, digital technology, and non-personal promotion to continue the dialogue with stakeholders to continue sales growth; an "Insight and Innovation Think Tank" has been established to evolve "next practices" during the peri- and post-COVID-19 period
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.
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
TD-1473 (gut-selective oral pan-Janus kinase (JAK) inhibitor for inflammatory intestinal diseases):
- Phase 2b/3 induction and maintenance study in ulcerative colitis (RHEA) and Phase 2 induction study in Crohn's disease (DIONE) progressing
- Data from the Phase 2b portion of the ulcerative colitis and Phase 2 Crohn's disease studies originally planned for late-2020 and now expected in 2021
TD-5202 (gut-selective irreversible JAK3 inhibitor for inflammatory intestinal diseases):
- TD-5202 was generally well tolerated as a single oral dose up to 2000 milligrams and as a twice-daily oral dose up to 2000 milligrams total per day given for 10 consecutive days in healthy subjects
Ampreloxetine (TD-9855, norepinephrine reuptake inhibitor (NRI) for symptomatic nOH):
- Ongoing registrational program in symptomatic neurogenic orthostatic hypertension (nOH) comprised of two studies:
- Phase 3 four-week treatment study (SEQUOIA) to demonstrate efficacy, with data originally planned for late-2020 and now expected in 2021
- Phase 3 four-month open label study followed by a six-week randomized withdrawal phase (REDWOOD) to demonstrate durability of response
TD-8236 (lung-selective inhaled pan-JAK inhibitor for inflammatory lung diseases):
- Part C extension portion of the Phase 1 trial assessing additional biomarkers in more severe asthmatics underway with results expected in 2H 2020
- Phase 2 lung allergen challenge initiated in 4Q 2019; data expected 2H 2020
TD-0903 (lung-selective nebulized pan-JAK inhibitor for treatment of Acute Lung Injury caused by COVID-19)
- Initiated Phase 1 study to assess the safety, tolerability and pharmacokinetics of single- and multiple-ascending doses (SAD/MAD) in healthy volunteers
- The program will then initially move to a nested Phase 2 study in hospitalized patients with COVID-19 with the first part (an ascending dose study) being conducted in the same clinical setting in the
UK as the Phase 1 study; the Medicines and Healthcare products Regulatory Agency (MHRA),United Kingdom approved the Phase 2 study today - The second part of the Phase 2 study will be a larger, multi-center study conducted at hospital-based clinical sites in the
UK , and potentially other clinical sites in theEuropean Union andUnited States ; both of the latter territories would join the Phase 2 study program subject to review and approval of the relevant regulatory approvals required by the relevant EU National Competent Authorities andFood and Drug Administration (FDA)
Economic Interest
TRELEGY ELLIPTA (first once-daily single inhaler triple therapy for COPD)1:
- 1Q 2020 net sales of
$249 million ;Theravance Biopharma entitled to approximately 5.5% to 8.5% (tiered) of worldwide net sales of the product - GSK sNDA for asthma expected 2H 2020; The
European Medicines Agency accepted the regulatory submission for the treatment of asthma in adults supported by the Phase III CAPTAIN study; FDA postponed Advisory Committee Meeting originally scheduled forApril 21, 2020 regarding mortality sNDA and no additional public information available at this time
Notes:
1 As reported by
First Quarter Financial Results
- Revenue: Revenue for the first quarter of 2020 was
$19.9 million , comprised of collaboration revenue of$6.6 million primarily attributed to the Janssen collaboration agreement for TD-1473 and$11.7 million in Mylan collaboration revenue related to YUPELRI. Revenue for the first quarter represents a$14.5 million increase over the same period in 2019. The increase was primarily due to an increase in Mylan collaboration revenue related to YUPELRI and a larger portion of recognized revenue related to the$100.0 million upfront payment from the Janssen collaboration agreement that was entered into inFebruary 2018 . - Research and Development Expenses: Research and Development (R&D) expenses for the first quarter of 2020 were
$66.0 million , compared to$53.8 million in the same period in 2019. The$12.2 million increase was primarily due to a$12.4 million increase in external-related expenses related to the advancement of our priority programs, notable TD-1473, ampreloxetine, and TD-8236, a$1.7 million increase in share-based compensation expense, and a$2.2 million decrease in employee-related expenses. First quarter R&D expenses included non-cash share-based compensation of$7.9 million . - Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the first quarter of 2020 were
$26.3 million , compared to$25.2 million in the same period in 2019. The$1.1 million increase was primarily attributed to a$1.4 million increase in share-based compensation expense, a$0.8 million increase in employee-related expenses, and a$0.6 million increase in external-related expenses. These increases were partially offset by a$1.4 million decrease related to collaboration expenses payable to Mylan in connection with the commercialization of YUPELRI which was formally launched in the first quarter of 2019. First quarter SG&A expenses included non-cash share-based compensation of$7.4 million . - Cash,
Cash Equivalents and Marketable Securities Cash, cash equivalents and marketable securities totaled$492.1 million as ofMarch 31, 2020 .
2020 Financial Guidance
- Operating Loss (excluding share-based compensation): The Company is not changing financial guidance and expects full-year 2020 operating loss, excluding share-based compensation, of
$205 million to$225 million . Operating loss guidance does not include:- Royalty income for TRELEGY ELLIPTA which the Company recognizes in its statement of operations as "income from investment in
TRC, LLC ;" or - Potential future business development collaborations
- Royalty income for TRELEGY ELLIPTA which the Company recognizes in its statement of operations as "income from investment in
Additionally, as previously announced, the Company closed its public offering of 5,500,000 ordinary shares at a price to the public of
On
Conference Call and Live Webcast Today at
A replay of the conference call will be available on
About
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 (COPD). Our pipeline of internally discovered programs is targeted to address significant patient needs.
We have an economic interest in potential future payments from
For more information, please visit www.theravance.com.
THERAVANCE® and the Cross/Star logo are registered trademarks of the
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.
Contact:
Corporate Communications and Investor Relations
917-214-6603
THERAVANCE BIOPHARMA, INC. |
|||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||
(In thousands) |
|||||
|
|
||||
2020 |
2019 |
||||
Assets |
(Unaudited) |
(1) |
|||
Current assets: |
|||||
Cash and cash equivalents and short-term marketable securities |
$ |
487,031 |
$ |
280,831 |
|
Receivables from collaborative arrangements |
14,214 |
11,996 |
|||
Receivables from licensing arrangements |
1,200 |
10,000 |
|||
Amounts due from |
26,282 |
28,574 |
|||
Other prepaid and current assets |
5,491 |
7,087 |
|||
Total current assets |
534,218 |
338,488 |
|||
Property and equipment, net |
13,905 |
12,644 |
|||
Long-term marketable securities |
5,067 |
4,985 |
|||
Operating lease assets |
46,106 |
46,604 |
|||
Restricted cash |
833 |
833 |
|||
Other assets |
5,280 |
5,272 |
|||
Total assets |
$ |
605,409 |
$ |
408,826 |
|
Liabilities and Shareholders' Deficit |
|||||
Current liabilities |
$ |
98,040 |
$ |
111,703 |
|
Convertible senior notes due 2023, net |
226,158 |
225,890 |
|||
Non-recourse notes due 2035, net |
373,854 |
- |
|||
Non-recourse notes due 2033, net |
- |
219,300 |
|||
Long-term operating lease liabilities |
47,199 |
47,725 |
|||
Other long-term liabilities |
18,094 |
28,048 |
|||
Shareholders' deficit |
(157,936) |
(223,840) |
|||
Total liabilities and shareholders' deficit |
$ |
605,409 |
$ |
408,826 |
________________________________ |
|||||
(1) |
The condensed consolidated balance sheet as of |
THERAVANCE BIOPHARMA, INC. |
||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||
(In thousands, except per share data) |
||||||
Three Months Ended |
||||||
2020 |
2019 |
|||||
(Unaudited) |
||||||
Revenue: |
||||||
Collaboration revenue |
$ |
6,632 |
$ |
5,338 |
||
Licensing revenue |
1,500 |
- |
||||
Mylan collaboration agreement |
11,730 |
- |
||||
Total revenue |
19,862 |
5,338 |
||||
Costs and expenses: |
||||||
Research and development (1) |
66,013 |
53,818 |
||||
Selling, general and administrative (1) |
26,325 |
25,186 |
||||
Total costs and expenses |
92,338 |
79,004 |
||||
Loss from operations |
(72,476) |
(73,666) |
||||
Income from investment in |
13,515 |
6,229 |
||||
Interest expense |
(9,941) |
(7,858) |
||||
Loss on extinguishment of debt |
(15,464) |
- |
||||
Interest and other income, net |
1,460 |
2,795 |
||||
Loss before income taxes |
(82,906) |
(72,500) |
||||
Provision for income tax expense |
(147) |
(80) |
||||
Net loss |
$ |
(83,053) |
$ |
(72,580) |
||
Net loss per share: |
||||||
Basic and diluted net loss per share |
$ |
(1.40) |
$ |
(1.32) |
||
Shares used to compute basic and diluted net loss per share |
59,463 |
54,938 |
||||
________________________________ |
||||||
(1) Amounts include share-based compensation expense as follows: |
||||||
Three Months Ended |
||||||
(In thousands) |
2020 |
2019 |
||||
Research and development |
$ |
7,865 |
$ |
6,159 |
||
Selling, general and administrative |
7,411 |
6,061 |
||||
Total share-based compensation expense |
$ |
15,276 |
$ |
12,220 |
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