Theravance Biopharma, Inc. Reports Second Quarter 2021 Financial Results and Provides Business Update
- Company reiterates Q3 2021 top-line results timing for ampreloxetine Phase 3 and izencitinib Phase 2b in ulcerative colitis
- Company's implied 35% share of YUPELRI® (revefenacin) US net sales(1): $14.6 million, up 38% from Q2 2020
- TRELEGY® Q2 2021 global net sales hit $405 million, up 68% from Q2 2020(2)
"We made strong progress in the second quarter. Our field team is energized and has recently been able to increase its face-to-face engagements with customers, driving continued sales volume and market share growth. As we look to the future for YUPELRI, we and our partner Viatris are initiating a controlled clinical study intended to provide data for a possible label update," said Rick E Winningham, Chief Executive Officer. "We continued to execute across our clinical trials and eagerly anticipate study results this quarter and later this year/early next. 2021 is a pivotal year for
Upcoming Clinical Milestones
- Q3 2021: Izencitinib (gut-selective oral pan-Janus kinase (JAK) inhibitor for inflammatory intestinal diseases) Phase 2b in ulcerative colitis (study 0157) – top-line results expected in Q3 2021.
- Q3 2021: Ampreloxetine (norepinephrine reuptake inhibitor) Phase 3 for symptomatic neurogenic orthostatic hypotension (study 0169) – enrollment complete and top-line results expected in Q3 2021.
- Q4 2021/Q1 2022: Izencitinib (gut-selective oral pan-JAK inhibitor for inflammatory intestinal diseases) Phase 2 in Crohn's disease (study 0173) – top-line results expected in late Q4 2021/early Q1 2022.
Quarterly Highlights
- YUPELRI® (revefenacin) inhalation solution, the first and only once-daily, nebulized bronchodilator approved in the U.S. for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), continued to increase its share of the long-acting nebulized COPD market, increasing to 21% in
April 2021 , up from 19% inJanuary 2021 , and net sales increased by 38% year-over-year (Q2 2020 vs. Q2 2021).- The Company, in collaboration with our partner Viatris, is also initiating a Phase 4 study comparing improvements in lung function in adults with severe to very severe COPD and suboptimal inspiratory flow rate following once-daily treatment with either YUPELRI® (revefenacin) delivered via standard jet nebulizer or tiotropium delivered via a dry powder inhaler (Spiriva® HandiHaler®). This study is aimed at helping to better inform decisions when physicians are designing a personalized COPD treatment plan with patients.
- Nezulcitinib, an investigational, inhaled, lung-selective, pan-JAK inhibitor in development for hospitalized patients with COVID-19, reported Phase 2 top-line results (read more about the data here).
- On
June 29, 2021 , the Company closed a public offering of ordinary shares at a price to the public of$15.00 per share, with gross proceeds of$115.6 million , before deducting underwriting discounts and commissions and offering expenses.
Economic Interest
- TRELEGY (first once-daily single inhaler triple therapy for COPD and asthma), in which the Company holds an economic interest, posted second quarter 2021 global net sales of
$405 million (up from$241 million , 68%, in the second quarter of 2020);Theravance Biopharma is entitled to tiered payments equal to approximately 5.5% to 8.5% of TRELEGY global net sales.3
Second Quarter Financial Results
- Revenue: Total revenue for the second quarter of 2021 was
$12.9 million , comprised of non-cash collaboration revenue of$2.0 million primarily attributed to our global collaboration with Janssen and$10.9 million in Viatris collaboration revenue. Total revenue for the second quarter represents a$2.1 million decrease over the same period in 2020.
- YUPELRI: The Viatris collaboration revenue of
$10.9 million for the second quarter of 2021 represents amounts receivable from Viatris and is comprised of the Company's 35% share of net sales of YUPELRI as well as its proportionate amount of the total shared costs incurred by the two companies. The non-shared YUPELRI costs incurred byTheravance Biopharma are recorded within operating expenses. While Viatris records the total net sales of YUPELRI within its financial statements, our implied 35% share of net sales of YUPELRI for the second quarter of 2021 was$14.6 million .
- Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2021 were
$51.1 million , compared to$62.4 million in the same period in 2020. Second quarter R&D expenses included total non-cash share-based compensation of$7.3 million .
- Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the second quarter of 2021 were
$25.9 million , compared to$24.8 million in the same period in 2020. Second quarter SG&A expenses included total non-cash share-based compensation of$7.6 million .
- Operating Loss: Operating loss for the second quarter of 2021 was
$64.1 million compared to$72.2 million in the same period of 2020.
- Cash Position: Cash, cash equivalents and marketable securities totaled
$265.0 million as ofJune 30, 2021 .
2021 Financial Guidance
- Operating Expenses (excluding share-based compensation): The Company reiterates that it expects full year 2021 R&D expense of
$195 million to$225 million , and SG&A expense of$80 million to$90 million .
Conference Call and Live Webcast Today at
A replay will be available on www.theravance.com for 30 days through
About
In pursuit of its purpose,
For more information, please visit www.theravance.com.
YUPELRI® is a registered trademark of
Forward-Looking Statements
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
917-214-6603
_________________________
1 While Viatris Inc. ("Viatris") records the total YUPELRI net sales, the Company is entitled to a 35% share of the profits and losses pursuant to a co-promotion agreement with Viatris.
2 As reported by
3 As reported by
THERAVANCE BIOPHARMA, INC. |
|||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||
(In thousands) |
|||||
|
|
||||
2021 |
2020 |
||||
Assets |
(Unaudited) |
(1) |
|||
Current assets: |
|||||
Cash and cash equivalents and short-term marketable securities |
$ |
264,953 |
$ |
292,941 |
|
Receivables from collaborative arrangements |
12,220 |
15,868 |
|||
Amounts due from |
27,741 |
53,799 |
|||
Prepaid clinical and development services |
15,913 |
20,374 |
|||
Other prepaid and current assets |
12,353 |
10,359 |
|||
Total current assets |
333,180 |
393,341 |
|||
Property and equipment, net |
16,583 |
16,422 |
|||
Operating lease assets |
41,508 |
43,260 |
|||
Equity in net assets of |
35,822 |
12,750 |
|||
Restricted cash |
833 |
833 |
|||
Other assets |
1,325 |
2,451 |
|||
Total assets |
$ |
429,251 |
$ |
469,057 |
|
Liabilities and Shareholders' Deficit |
|||||
Current liabilities |
$ |
67,127 |
$ |
123,571 |
|
Convertible senior notes due 2023, net |
227,499 |
226,963 |
|||
Non-recourse notes due 2035, net |
375,069 |
372,873 |
|||
Long-term operating lease liabilities |
57,768 |
47,220 |
|||
Other long-term liabilities |
2,162 |
2,181 |
|||
Shareholders' deficit |
(300,374) |
(303,751) |
|||
Total liabilities and shareholders' deficit |
$ |
429,251 |
$ |
469,057 |
|
________________________________ |
|||||
(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 |
Six Months Ended |
|||||||||||
2021 |
2020 |
2021 |
2020 |
|||||||||
(Unaudited) |
(Unaudited) |
|||||||||||
Revenue: |
||||||||||||
Collaboration revenue |
$ |
1,980 |
$ |
5,488 |
$ |
5,852 |
$ |
12,120 |
||||
Licensing revenue |
- |
- |
- |
1,500 |
||||||||
Viatris collaboration agreement |
10,934 |
9,520 |
21,319 |
21,250 |
||||||||
Total revenue |
12,914 |
15,008 |
27,171 |
34,870 |
||||||||
Costs and expenses: |
||||||||||||
Research and development (1) |
51,093 |
62,404 |
118,692 |
128,417 |
||||||||
Selling, general and administrative (1) |
25,931 |
24,780 |
56,481 |
51,105 |
||||||||
Total costs and expenses |
77,024 |
87,184 |
175,173 |
179,522 |
||||||||
Loss from operations |
(64,110) |
(72,176) |
(148,002) |
(144,652) |
||||||||
Income from investment in |
21,926 |
21,381 |
38,473 |
34,896 |
||||||||
Interest expense |
(11,612) |
(11,391) |
(23,485) |
(21,332) |
||||||||
Loss on extinguishment of debt |
- |
- |
- |
(15,464) |
||||||||
Interest and other income (expense), net |
1,171 |
(662) |
937 |
798 |
||||||||
Loss before income taxes |
(52,625) |
(62,848) |
(132,077) |
(145,754) |
||||||||
Provision for income tax benefit (expense) |
220 |
(39) |
(7) |
(186) |
||||||||
Net loss |
$ |
(52,405) |
$ |
(62,887) |
$ |
(132,084) |
$ |
(145,940) |
||||
Net loss per share: |
||||||||||||
Basic and diluted net loss per share |
$ |
(0.80) |
$ |
(1.00) |
$ |
(2.03) |
$ |
(2.39) |
||||
Shares used to compute basic and diluted net loss per share |
65,669 |
62,861 |
65,085 |
61,162 |
||||||||
________________________________ |
||||||||||||
(1)Amounts include share-based compensation expense as follows: |
||||||||||||
Three Months Ended |
Six Months Ended |
|||||||||||
(In thousands) |
2021 |
2020 |
2021 |
2020 |
||||||||
Research and development |
$ |
7,315 |
$ |
8,098 |
$ |
15,236 |
$ |
15,963 |
||||
Selling, general and administrative |
7,626 |
8,487 |
15,537 |
15,898 |
||||||||
Total share-based compensation expense |
$ |
14,941 |
$ |
16,585 |
$ |
30,773 |
$ |
31,861 |
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