Theravance Biopharma, Inc. Reports First Quarter 2018 Financial Results and Provides Business Update
Rick E Winningham, Chairman and Chief Executive Officer, commented: "We are very pleased with our achievements in the first quarter of 2018, led by our global collaboration with Janssen for the development and commercialization of TD-1473 in inflammatory intestinal diseases. As we look to the remainder of 2018, we are enhancing our focus on the most important strategic priorities for the Company, which are those programs where we think there is the greatest opportunity to create transformational medicines. For revefenacin, our commercial readiness activities are underway in anticipation of approval in the US for COPD later this year. With TD-1473 for ulcerative colitis and Crohn's disease and TD-9855 for neurogenic orthostatic hypotension, we are advancing two highly differentiated assets through mid-stage development. In research, we are preparing to progress a novel inhaled JAK inhibitor for serious respiratory diseases into the clinic. These assets, combined with our strong balance sheet and emerging cash flows from our economic interest in Trelegy Ellipta, position us to advance all segments of our business – from research to commercial – with the goal of creating transformational medicines."
Program Updates
- Trelegy Ellipta (first once-daily single inhaler triple therapy for chronic obstructive pulmonary disease (COPD))1: GSK reported first quarter 2018 net sales of
$14.6 million ;Theravance Biopharma entitled to approximately 5.5% to 8.5% of worldwide net sales of the productU.S. Food and Drug Administration (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- Expanded indication based on the positive results of the landmark 10,355 patient IMPACT study, which was recently published in the
New England Journal of Medicine - Boxed warning removed from Trelegy Ellipta prescribing information
- Velusetrag (TD-5108; 5-HT4 agonist): Collaboration partner Alfasigma S.p.A. (Alfasigma), which funded majority of Phase 2 gastroparesis program costs, has exercised its option to develop and commercialize velusetrag
- Alfasigma opt-in decision results in
$10 million payment to Company and right to receive future potential development, regulatory and sales milestone payments and royalties Theravance Biopharma has elected not to pursue further development of velusetrag, based on the Company's planned pipeline investments and in light of the currentFDA requirement that a chronically administered gastroparesis product in this class complete a large Phase 3 safety study- Global rights to develop, manufacture and commercialize velusetrag will transfer to Alfasigma, under the terms of the existing collaboration agreement
- Alfasigma opt-in decision results in
- Revefenacin (TD-4208, nebulized long-acting muscarinic antagonist (LAMA)): Mid-cycle review meeting with
FDA is completeFDA reiterated no Advisory Committee meeting planned for revefenacin- Prescription Drug User Fee Act (PDUFA) date remains on track as
November 13, 2018
Anticipated Near-Term Milestones and Events
- TD-1473 (intestinally restricted pan-Janus kinase (JAK) inhibitor): Initiations of Phase 2 induction study in Crohn's disease and Phase 2b/3 induction and maintenance study in ulcerative colitis planned in the second half of 2018
- TD-9855 (norepinephrine serotonin reuptake inhibitor (NSRI)): Data from exploratory Phase 2a study in patients with symptomatic neurogenic orthostatic hypotension (nOH) by end of
July 2018 - Revefenacin (TD-4208, nebulized long-acting muscarinic antagonist (LAMA)): Potential regulatory approval in the US for COPD, with assigned PDUFA date of
November 13, 2018 - Novel inhaled JAK inhibitor: Progression into first-in-human studies in late 2018 or early 2019
- Trelegy Ellipta1: Potential label expansion in EU expected in 2018, supported by submission of IMPACT data to
European Medicines Agency ; completion of Phase 3 CAPTAIN study in asthma patients expected in early 2019
Notes:
1 As reported by
First Quarter Financial Results
Revenue
Revenue for the first quarter of 2018 was
Research and Development (R&D) Expenses
R&D expenses for the first quarter of 2018 were
Selling, General and Administrative (SG&A) Expenses
SG&A expenses for the first 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 March 31, |
|||||||
2018 |
2017 |
||||||
(Unaudited) |
|||||||
Revenue: |
|||||||
Product sales |
$ |
3,679 |
$ |
3,050 |
|||
Revenue from collaborative arrangements |
4,640 |
37 |
|||||
Total revenue |
8,319 |
3,087 |
|||||
Costs and expenses: |
|||||||
Cost of goods sold |
826 |
565 |
|||||
Research and development (1) |
47,765 |
40,565 |
|||||
Selling, general and administrative (1) |
24,704 |
20,786 |
|||||
Total costs and expenses |
73,295 |
61,916 |
|||||
Loss from operations |
(64,976) |
(58,829) |
|||||
Interest expense |
(2,137) |
(2,137) |
|||||
Interest and other income |
2,170 |
1,030 |
|||||
Loss before income taxes |
(64,943) |
(59,936) |
|||||
Provision for income taxes |
144 |
5,383 |
|||||
Net loss |
$ |
(65,087) |
$ |
(65,319) |
|||
Net loss per share: |
|||||||
Basic and diluted net loss per share |
$ |
(1.22) |
$ |
(1.27) |
|||
Shares used to compute basic and diluted net loss per share |
53,256 |
51,617 |
|||||
________________________________ |
|||||||
(1) |
Amounts include share-based compensation expense as follows: |
||||||
Three Months Ended March 31, |
|||||||
(In thousands) |
2018 |
2017 |
|||||
Research and development |
$ |
6,559 |
$ |
5,101 |
|||
Selling, general and administrative |
7,439 |
5,168 |
|||||
Total share-based compensation expense |
$ |
13,998 |
$ |
10,269 |
THERAVANCE BIOPHARMA, INC. |
|||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||
(In thousands) |
|||||
March 31, |
December 31, |
||||
2018 |
2017 |
||||
Assets |
(Unaudited) |
(1) |
|||
Current assets: |
|||||
Cash and cash equivalents and short-term marketable securities |
$ |
418,531 |
$ |
348,566 |
|
Receivables from collaborative arrangements |
2,845 |
7,109 |
|||
Prepaid taxes |
926 |
291 |
|||
Other prepaid and current assets |
7,299 |
5,953 |
|||
Inventories |
17,217 |
16,830 |
|||
Property and equipment, net |
10,329 |
10,157 |
|||
Long-term marketable securities |
16,999 |
41,587 |
|||
Tax receivable |
3,324 |
8,191 |
|||
Restricted cash |
833 |
833 |
|||
Other assets |
1,805 |
1,883 |
|||
Total assets |
$ |
480,108 |
$ |
441,400 |
|
Liabilities and Shareholders' Equity |
|||||
Current liabilities |
105,179 |
62,552 |
|||
Long-term liabilities |
311,522 |
263,670 |
|||
Shareholders' equity |
63,407 |
115,178 |
|||
Total liabilities and shareholders' equity |
$ |
480,108 |
$ |
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. |
View original content with multimedia:http://www.prnewswire.com/news-releases/theravance-biopharma-inc-reports-first-quarter-2018-financial-results-and-provides-business-update-300644739.html
SOURCE