Theravance Biopharma, Inc. Reports Second Quarter 2018 Financial Results and Provides Business Update
Rick E Winningham, Chairman and Chief Executive Officer, commented: "We have made exciting progress across our portfolio. Positive data from the TD-1473 Phase 1b study in ulcerative colitis and TD-9855 Phase 2 study in nOH provide strong clinical rationale for the progression into registrational programs, and with regulatory dialogues recently completed, each program now has a clear path into late-stage studies. For YUPELRI™, our brand name for revefenacin, we and our partner Mylan are finalizing launch readiness activities in anticipation of a potential
Program Updates and Upcoming Milestones
TD-1473 (intestinally restricted pan-Janus kinase (JAK) inhibitor):
- Phase 1b study in 40 patients with ulcerative colitis complete; results demonstrate localized biologic activity and minimal systemic exposure, with a favorable safety and tolerability profile
- Rates of clinical response were higher on all active doses (20, 80, 270 mg) compared with placebo using both partial and total Mayo definitions, with greatest effect seen at the 270 mg dose
- Rectal bleeding scores improved above placebo at the 80 and 270 mg doses
- Endoscopic improvements and mucosal healing were reported in all active arms, none in placebo arm
- Plasma pharmacokinetic (PK) levels were low and consistent with data from healthy volunteers; local GI tissue PK levels above JAK inhibitory concentrations (IC50) for 80 and 270 mg dose
- TD-1473 was generally well tolerated at all doses
- Company and partner
Janssen Biotech, Inc. plan to present full results from the Phase 1b study at a future medical meeting
- Initiation of Phase 2 induction study in Crohn's disease planned in third quarter of 2018
- Initiation of Phase 2b/3 induction and maintenance study in ulcerative colitis planned in fourth quarter of 2018, following completion of the Phase 1b study and successful dialogues with
U.S. Food and Drug Administration (FDA ) andEuropean Medicines Authority (EMA)
TD-9855 (norepinephrine serotonin reuptake inhibitor (NSRI)):
- Positive data from the Phase 2 study in patients with neurogenic orthostatic hypotension (nOH), as detailed in a separate press release this morning. The Phase 2 trial was designed to evaluate the effect of TD-9855 in improving key symptoms and blood pressure
- 27 of 34 (79%) patients who were enrolled in the single-ascending portion of the study demonstrated an improvement in blood pressure or standing time
- A statistically significant difference of 30 mm Hg (p = 0.011) was observed in systolic blood pressure between active (n=5) and placebo (n=5) at the four-hour time point post-dose in the single dose placebo-controlled portion of the study. These patients had a lower than normal mean SBP at baseline, consistent with nOH
- Of the 21 patients who started the repeat-dose portion of the study, 16 (76%) remained on therapy after four weeks
- Durable improvements in nOH symptom severity were observed as measured by OHSA Question #1 (a measure of dizziness, light-headedness or the sensation of being about to black out): the improvement was 2.4 points at the four-week time point1
- 13 of the 16 patients who completed four weeks of dosing entered the trial with OHSA #1 of > 4 (a threshold that will be applied in the registrational studies), and these patients reported a mean OHSA #1 reduction of 3.8 points at four weeks
- Consistent increases in systolic blood pressure (SBP), including clinically meaningful improvements in standing SBP (7 mm Hg or greater) after standing for three minutes at all assessment time points and at all weekly visits over four weeks
- TD-9855 was generally well tolerated, with no new safety findings attributable to drug observed in the study
- Initiation of a registrational Phase 3 program in nOH planned in late 2018 or early 2019 following positive data from the Phase 2 study and successful dialogue with
FDA - Presentation of preclinical TD-9855 findings at the
Movement Disorders Congress in October
YUPELRI™ (revefenacin, TD-4208, nebulized long-acting muscarinic antagonist (LAMA)):
- Prescription Drug User Fee Act (PDUFA) date remains on track as
November 13, 2018 - Oral presentation of the effect of revefenacin on reducing exacerbation rates in chronic obstructive pulmonary disease (COPD) based on the Phase 3 clinical program at
European Respiratory Society (ERS)Paris 2018International Congress in September
Trelegy Ellipta (first once-daily single inhaler triple therapy for COPD)2:
- GSK reported second quarter 2018 net sales of
$36.5 million ;Theravance Biopharma entitled to approximately 5.5% to 8.5% (tiered) of worldwide net sales of the product - In April,
FDA approved an expanded indication of Trelegy Ellipta for treatment of a broader population of COPD patients with airflow limitation or who have experienced an acute worsening of respiratory symptoms; boxed warning removed from Trelegy Ellipta prescribing information - Regulatory application recently submitted to
Japanese Ministry of Health, Labor and Welfare (MHLW) for the treatment of adults with chronic COPD - Potential label expansion in EU and regulatory approval in
Japan expected; completion of Phase 3 CAPTAIN study in asthma patients anticipated in early 2019
TD-8236 (novel inhaled JAK inhibitor for serious respiratory diseases):
- Progression into first-in-human studies in late 2018, leveraging expertise in respiratory diseases and JAK inhibition
- Multiple JAK-dependent pathways clinically validated in asthma and COPD
- Potentially broad activity with JAK inhibition across a range of respiratory indications and phenotypes
2018 R&D Day
- Planned in December to focus on
Theravance Biopharma research and next programs potentially progressing into clinic
Notes:
1OHSA (Orthostatic Hypotension Symptom Assessment) is a validated scale assessing the presence of a range of symptoms in patients with nOH including dizziness, weakness, problems with vision, fatigue, trouble concentrating and head/neck discomfort
2 As reported by
Second Quarter Financial Results
Revenue
Revenue for the second quarter of 2018 was
Research and Development (R&D) Expenses
R&D expenses for the second quarter of 2018 were
Selling, General and Administrative (SG&A) Expenses
SG&A expenses for the second quarter of 2018 were
Cash,
Cash, cash equivalents and marketable securities, excluding restricted cash, totaled
2018 Financial Guidance
The Company's guidance on operating loss excluding non-cash share-based compensation for the full year of 2018 remains unchanged at
Conference Call and Live Webcast Today at
A replay of the conference call will be available on
About
In our relentless pursuit of this objective, we strive to apply insight and innovation at each stage of our business, including research, development and commercialization, and utilize both internal capabilities and those of partners around the world. Our research efforts are focused in the areas of inflammation and immunology. Our research goal is to design localized medicines that target diseased tissues, without systemic exposure, in order to maximize patient benefit and minimize risk. These efforts leverage years of experience in developing localized medicines for the lungs to treat respiratory disease. The first potential medicine to emerge from our research focus on immunology and localized treatments is an oral, intestinally restricted pan-Janus kinase (JAK) inhibitor, currently in development to treat a range of inflammatory intestinal diseases. Our pipeline of internally discovered product candidates will continue to evolve with the goal of creating transformational medicines to address the significant needs of patients.
In addition, we have an economic interest in future payments that may be made by
For more information, please visit www.theravance.com.
THERAVANCE®, the Cross/Star logo, and VIBATIV® 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 Information:
Head of Investor Relations
650-808-4045
investor.relations@theravance.com
THERAVANCE BIOPHARMA, INC. |
||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||||||
(In thousands, except per share data) |
||||||||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||
2018 |
2017 |
2018 |
2017 |
|||||||||
(Unaudited) |
(Unaudited) |
|||||||||||
Revenue: |
||||||||||||
Product sales |
$ |
5,361 |
$ |
3,474 |
$ |
9,040 |
$ |
6,524 |
||||
Revenue from collaborative arrangements |
18,115 |
35 |
22,755 |
72 |
||||||||
Total revenue |
23,476 |
3,509 |
31,795 |
6,596 |
||||||||
Costs and expenses: |
||||||||||||
Cost of goods sold |
(1,448) |
1,364 |
(622) |
1,929 |
||||||||
Research and development (1) |
48,621 |
42,927 |
96,386 |
83,492 |
||||||||
Selling, general and administrative (1) |
25,007 |
24,339 |
49,711 |
45,125 |
||||||||
Total costs and expenses |
72,180 |
68,630 |
145,475 |
130,546 |
||||||||
Loss from operations |
(48,704) |
(65,121) |
(113,680) |
(123,950) |
||||||||
Income from investment in TRC, LLC |
1,949 |
- |
2,635 |
- |
||||||||
Interest expense |
(2,137) |
(2,137) |
(4,274) |
(4,274) |
||||||||
Interest and other income |
1,284 |
1,425 |
2,768 |
2,455 |
||||||||
Loss before income taxes |
(47,608) |
(65,833) |
(112,551) |
(125,769) |
||||||||
Provision for income tax (benefit) |
(6,790) |
454 |
(6,646) |
5,837 |
||||||||
Net loss |
$ |
(40,818) |
$ |
(66,287) |
$ |
(105,905) |
$ |
(131,606) |
||||
Net loss per share: |
||||||||||||
Basic and diluted net loss per share |
$ |
(0.76) |
$ |
(1.27) |
$ |
(1.98) |
$ |
(2.53) |
||||
Shares used to compute basic and diluted net loss per share |
53,799 |
52,255 |
53,529 |
51,938 |
||||||||
________________________________ |
||||||||||||
(1) Amounts include share-based compensation expense as follows: |
||||||||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||
(In thousands) |
2018 |
2017 |
2018 |
2017 |
||||||||
Research and development |
$ |
6,904 |
$ |
4,917 |
$ |
13,463 |
$ |
10,018 |
||||
Selling, general and administrative |
6,951 |
5,481 |
14,390 |
10,649 |
||||||||
Total share-based compensation expense |
$ |
13,855 |
$ |
10,398 |
$ |
27,853 |
$ |
20,667 |
THERAVANCE BIOPHARMA, INC. |
|||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||
(In thousands) |
|||||
June 30, |
December 31, |
||||
2018 |
2017 |
||||
Assets |
(Unaudited) |
(1) |
|||
Current assets: |
|||||
Cash and cash equivalents and short-term marketable securities |
$ |
352,903 |
$ |
348,566 |
|
Receivables from collaborative arrangements |
3,865 |
7,109 |
|||
Prepaid taxes |
944 |
291 |
|||
Other prepaid and current assets |
11,075 |
5,953 |
|||
Inventories |
17,906 |
16,830 |
|||
Property and equipment, net |
10,677 |
10,157 |
|||
Long-term marketable securities |
18,252 |
41,587 |
|||
Tax receivable |
3,143 |
8,191 |
|||
Restricted cash |
833 |
833 |
|||
Other assets |
1,766 |
1,883 |
|||
Total assets |
$ |
421,364 |
$ |
441,400 |
|
Liabilities and Shareholders' Equity |
|||||
Current liabilities |
93,480 |
62,552 |
|||
Long-term liabilities |
293,497 |
263,670 |
|||
Shareholders' equity |
34,387 |
115,178 |
|||
Total liabilities and shareholders' equity |
$ |
421,364 |
$ |
441,400 |
____________________________________ |
||||||
(1) |
The condensed consolidated balance sheet at December 31, 2017 has been derived from the audited consolidated financial statements included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2017. |
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