SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
Current Report Pursuant
to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event Reported): January 7, 2019
THERAVANCE BIOPHARMA, INC.
(Exact Name of Registrant as Specified in its Charter)
(State or Other Jurisdiction of
(Commission File Number)
(I.R.S. Employer Identification
PO Box 309
Ugland House, South Church Street
George Town, Grand Cayman, Cayman Islands KY1-1104
(Addresses, including zip code, and telephone numbers, including area code, of principal executive offices)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Item 2.05 Costs Associated with Exit or Disposal Activities.
On January 7, 2019, Theravance Biopharma, Inc. (the Company) announced a reduction in workforce to align with its focus on continued execution of key strategic programs, and advancement of selected late-stage research programs toward clinical development. The Company will reduce its overall headcount by approximately 50 individuals, with the affected employees primarily focused on early research or the infrastructure in support of VIBATIV® (telavancin), a marketed antibiotic recently sold by the Company to Cumberland Pharmaceuticals, Inc. The workforce reduction is expected to be substantially completed in the first quarter of 2019.
As a result of the workforce reduction, the Company expects to record severance related charges totaling approximately $2.5 - 3.0 million, which includes one-time cash severance payments and continued health insurance coverage but does not include ordinary course compensation expense that will continue to be made to affected employees during any statutory notice periods. A significant majority of the cash payments relating to personnel-related restructuring charges will be paid during the first quarter of 2019.
The charges that the Company expects to incur in connection with the workforce reduction are estimates and subject to a number of assumptions, and actual results may differ materially. The Company may incur additional costs not currently contemplated due to events associated with or resulting from the workforce reduction.
Item 7.01 Regulation FD Disclosure.
The information in this Current Report (including Exhibit 99.1) is being furnished and shall not be deemed filed for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in this Current Report (including Exhibit 99.1) shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Between January 7-10, 2019, members of the Theravance Biopharma, Inc. management team will be conducting meetings with analysts and investors in San Francisco, CA. A copy of the slide presentation for these meetings is being furnished pursuant to Regulation FD as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 8.01 Other Events.
On January 7, 2019, the Company issued a press release announcing a reduction in force and related matters. A copy of the press release is attached hereto as Exhibit 99.2 and incorporated by reference into this Item 8.01.
Item 9.01. Financial Statements and Exhibits.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
THERAVANCE BIOPHARMA, INC.
Date: January 7, 2019
/s/ Bradford J. Shafer
Bradford J. Shafer
Executive Vice President and General Counsel
Theravance Biopharma, Inc. (NASDAQ: TBPH) Investor Presentation January 2019 THERAVANCE®, the Cross/Star logo, and MEDICINES THAT MAKE A DIFFERENCE® are registered trademarks of the Theravance Biopharma group of companies. All third party trademarks used herein are the property of their respective owners. © 2019 Theravance Biopharma. All rights reserved.
Forward Looking Statements Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company are subject to risks and uncertainties that may cause actual results to differ materially from the forward-looking statements or projections. Examples of forward-looking statements in this presentation include statements relating to the companys business plans and objectives, including financial and operating results, potential partnering transactions and sales targets, the companys regulatory strategies and timing and results of clinical studies, the potential benefits and mechanisms of action of the companys product and product candidates (including their potential as
components of combination therapies). The companys forward-looking statements are based on the estimates and assumptions of management as of the date of this presentation and are subject to risks and uncertainties that may cause the actual results to be materially different than those projected, such as risks related to delays or difficulties in commencing or completing clinical studies, the potential that results from clinical or non-clinical studies indicate product candidates are unsafe or ineffective (including when our product candidates are studied in combination with other compounds), delays or failure to achieve and maintain regulatory approvals for product candidates, risks of collaborating with third parties to discover, develop and commercialize products, risks associated with establishing and maintaining sales, marketing and distribution capabilities. Other risks affecting the company are described under the heading Risk Factors and elsewhere in the companys Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 8, 2018, and other periodic reports filed with the SEC. 2
3 Focus on discovering transformational medicines Create value from strategic integration of key functional insights Focus on transformative products to deliver value to payers, patients and HCPs Pursue medicines with difficult-to-replicate design characteristics for long term competitive advantage Proven development expertise to deliver innovation Leverage preclinical data and translational science expertise to design clinical studies that provide insights and maximize value of early programs Integrated approach accelerates time to pivotal studies Partnerships to complement and expand existing expertise Established commercial infrastructure surrounds value proposition Strategic objective to transform the treatment of serious diseases with novel, locally acting organ-selective therapies Insight and Innovation Drive Long-term Growth
4 Conventional Oral Compound Permeability Solubility Bioavailability, % Systemic Clearance GI Tissue : Plasma Ratio Organ-selectivity Aimed to Expand Therapeutic Index EFFECTIVE NON-EFFECTIVE DOSE-LIMITING SAFETY NON-EFFECTIVE DOSE-LIMITING SAFETY EFFECTIVE Theravance Biopharma Organ-selective Compound Illustrated example: lung selectivity
5 First patient dosed in Phase 2 study in Crohns TD-1473 Patient screening in Phase 2b/3 study in UC TD-1473 Completion of Phase 2a study in nOH Ampreloxetine Sites initiated for Phase 3 program enrollment Ampreloxetine Global collaboration agreement with Janssen TD-1473 Completion of Phase 1b study in UC TD-1473 Initiation of FIH study of lung-selective JAKi TD-8236 Completion of Phase 3b PIFR study YUPELRITM FDA approval and commercial launch YUPELRITM 1 Pro forma cash of approximately $570M excluding expected 4Q18 loss. 2 Economic interest. TBPH holds 85% economic interest in upward-tiering royalty stream of 6.5% 10% payable by GSK (net of TRC LLC expenses paid and the amount of cash, if any, expected to be used by TRC pursuant to the TRC LLC Agreement over the next four fiscal quarters). YUPELRITM (revefenacin) inhalation solution. UC: ulcerative colitis. FIH: first in human. JAKi: Janus kinase inhibitor. nOH: neurogenic orthostatic hypotension. PIFR: peak inspiratory flow rate. $250M transaction (net proceeds ~$230M)1 TRELEGY ELLIPTA2 Debt Royalty 2018 Key Milestones
6 Commercial organization to concentrate on YUPELRITM Economic interest in TRELEGY ELLIPTA serves as an important strategic asset1 Strong launch following approvals in US and EU in late 2017 TD-1473, ampreloxetine, and YUPELRITM each internally discovered and developed by R&D engine which serves as important driver of long term value APPROVED BY FDA First once-daily nebulized LAMA for treatment of COPD; launch underway Positive top-line four-week results in nOH Initiating pivotal Phase 3 program in symptomatic nOH TD-1473 (JAKi) Ampreloxetine (NSRI) YUPELRITM (LAMA) Partnership with global leader in Immunology Phase 2 study in Crohns disease underway and initiating pivotal Phase 2b/3 study in ulcerative colitis 1 TBPH holds 85% economic interest in upward-tiering royalty stream of 6.5% 10% payable by GSK (net of TRC LLC expenses paid and the amount of cash, if any, expected to be used by TRC pursuant to the TRC LLC Agreement over the next four fiscal quarters). NSRI: norepinephrine serotonin reuptake inhibitor. LAMA: long-acting muscarinic antagonist. COPD: chronic obstructive pulmonary disease. Strategic Focus in 2019
YUPELRITM (revefenacin) inhalation solution Nebulized long-acting muscarinic antagonist (LAMA)
YUPELRITM: Now Commercially Available FDA-APPROVED FOR THE MAINTENANCE TREATMENT OF COPD 8 FEV1: forced expiratory volume in one second. LABA: long-active beta agonist. ICS: inhaled corticosteroid. Single cycle approval ahead of expected PDUFA date, without an Advisory Committee Higher of two doses approved: 175 mcg once daily, for use with any standard jet nebulizer Label incorporates: Data illustrating change from baseline in trough FEV1 after 12 weeks of dosing Data illustrating sustained treatment effect over 24 hours Observed improvements across a range of patients 37% of patients took concomitant LABA or LABA/ICS Summary of safety data and most common side effects Direction to store at room temperature
NDA Supported by Positive Phase 3 Results TWO REPLICATE EFFICACY STUDIES, PLUS 12-MONTH SAFETY STUDY 9 Pooled analysis. Primary endpoint achieved for both doses in replicate efficacy studies Robust and sustained improvements in FEV1 Study included use as monotherapy as well as add-on to LABA or LABA/ICS Generally well tolerated in 12-month safety study * * * Monotherapy Concomitant LABA Pooled Population * P < 0.0001 versus placebo 175 mcg
Partnership with Mylan Provides Commercial Strength in Nebulized Opportunity 10 1 IMS Health information service: NSP for period MAT May, 2015. Excludes nebulized SABAs. IMS expressly reserves all rights, including rights of copying, distribution and republication. 2 TBPH market research (N = 160 physicians); refers to US COPD patients. HD = hospital discharge. Enduring patient niche and significant market opportunity >100M patient treatment days in nebulized COPD segment1 9% of COPD patients currently use nebulizers for ongoing maintenance therapy2 41% of COPD patients use nebulizers at least occasionally for bronchodilator therapy2 Combined sales infrastructures to cover Hospital, Hospital Discharge and Home Health settings HD +
TD-1473 JAK Inhibitor Program Oral gut-selective pan-Janus kinase (JAK) inhibitor for ulcerative colitis and other inflammatory intestinal diseases
Differentiated and Potential Breakthrough Approach ADVANCING IN COLLABORATION WITH JANSSEN IN UC AND CROHNS 12 TD-1473 program objectives: Oral pan-JAK inhibitor that distributes selectively throughout the intestines to treat inflammatory intestinal disease locally, with minimal systemic exposure or corresponding immunosuppressive effects, to enhance safety and efficacy Phase 1b study in UC patients complete Data demonstrated localized biological target engagement with minimal systemic exposure Clinical responses after only 4 weeks of therapy Preclinical models of UC confirmed Improvements in diseases scores, local absorption and penetration of TD-1473 throughout intestinal tract Phase 3 enabling toxicology complete Favorable safety margins in 6 and 9 month studies
Encouraging Findings in Phase 1b Study 4-WEEK TREATMENT IN 40 PATIENTS WITH ULCERATIVE COLITIS 13 Detailed results presented in oral late-breaker at UEGW 2018; Phase 2 in Crohns disease underway and progressing into Phase 2b/3 in UC 1 Clinical response as measured by both partial and full Mayo. 2 Surrogate biomarkers include C-reactive protein (CRP) and fecal calprotectin. Key Findings Favorable overall safety and tolerability No systemic or opportunistic infections (including herpes zoster) No evidence of reduce white cell counts Minimal systemic exposure Plasma levels of TD-1473 very low Consistent in all cohorts to levels observed in healthy volunteers Biologic activity in GI tract Endoscopic improvements and mucosal healing reported in all active arms; none reported in placebo arm Rectal bleeding scores improved above placebo at highest two doses Rates of clinical response higher for all active doses compared to placebo1 Clinical responses matched by dose-dependent reductions in surrogate biomarkers2 Dose-related increases in local GI tissue drug concentrations; higher two doses produced mean concentrations above JAK IC50
Phase 3 induction, 2 arms (N=640) Dose-confirming induction, 8 weeks Phase 2b induction, 4 arms (N=240) Dose-finding induction, 8 weeks 14 Phase 3 maintenance 44 weeks Phase 2b/3 study in ulcerative colitis Phase 2 study in Crohns disease Phase 2 study, 3 arms (N=160) Dose-finding induction, 12 weeks Active treatment extension, 2 arms 24 weeks Responders Responders Late-stage Studies of TD-1473 in UC and Crohns Disease
Global Collaboration Agreement for TD-1473 PURPOSED TO MAXIMIZE VALUE OF PROGRAM 15 Shared belief in TD-1473 as gut-selective with potential to transform the treatment landscape in inflammatory intestinal disease Meaningful program enhancements Accelerate clinical development and advance UC and Crohns in parallel Apply Janssen expertise in IBD to optimize clinical strategy and execution Maximize worldwide commercial opportunity Attractive deal economics reducing overall financial risk Deal value up to $1B milestones, including $100M upfront; additional profit-share in US Collaboration with global leader in immunology represents milestone for TD-1473, our internally discovered pipeline and strategy to design organ-selective medicines
Ampreloxetine (TD-9855) Once-daily dual norepinephrine and serotonin reuptake inhibitor (NSRI) for neurogenic orthostatic hypotension (nOH)
17 1 Existing options associated with one or both therapies noted above; Northera prescribing information. MSA: multiple system atrophy. PD: Parkinsons disease. PAF: primary autonomic failure. TID: three times per day. nOH characterized by a sustained drop in blood pressure upon standing, due to body producing insufficient levels of norepinephrine (NE) Associated with several autonomic disorders: MSA, PD, PAF Symptoms include dizziness, fainting, blurred vision and weakness Orphan indication with < 200k patients in US Opportunity exists for safe and effective treatment Only droxidopa (Northera) and midodrine FDA-approved for nOH Synthetic exogenous NE analogues impact disease by increasing vascular tone Limitations of current therapy: Supine hypertension, TID dosing, patients refractory or discontinue, lack of durability1 Ideal therapy would target durable improvement in symptoms and daily function NE NE NE NE NET NET NE Vasodilation lowers blood pressure Blood pressure key biological driver to nOH symptoms Symptomatic nOH Represents a Significant Unmet Need
NET Inhibition with Ampreloxetine Offers Potential to Restore Vascular Sympathetic Tone 18 1 Includes Phase 1 SAD/MAD, elderly, and PET studies in healthy subjects and Phase 2a studies in fibromyalgia and ADHD patients. NET: norepinephrine transporter. QD: once-daily. A path to treating symptomatic nOH without introducing exogenous NE Blockade of NET in nOH patients inhibits endogenous neuronal NE uptake Increased levels of NE in the synapse cause vasoconstriction and a corresponding increase in blood pressure Increase in blood pressure improves symptoms Rationale for ampreloxetine in nOH NSRI with NE dominance confirmed in humans QD dosing, long half-life, and metabolic profile for potential improved patient outcomes Favorable safety and tolerability profile established in > 500 subjects1 Vasoconstriction to increase blood pressure + Ampreloxetine NE NE NE NE NET NET NE NE NE
Overview of Phase 2 Study in nOH DESIGNED TO EVALUATE INITIAL AND DURABLE RESPONSE TO THERAPY 19 Purpose: To evaluate the effect of ampreloxetine in improving blood pressure and key nOH symptoms Part C: Responders in Part A eligible for open-label treatment for up to 5 months Designed to assess durability of effect Primary assessment at four weeks (Day 29) Efficacy evaluations: OHSA1 #1, standing time duration, standing systolic blood pressure Also assessed safety and pharmacokinetics of ampreloxetine 1 OHSA: Orthostatic Hypotension Symptom Assessment. OHSA #1 measures dizziness (cardinal symptom of nOH), lightheadedness, feeling faint, or feeling of impending black out. Three-part design in patients with nOH: Single ascending dose portion of ampreloxetine (up to 20 mg) Testing blood pressure response to ampreloxetine A Patients started on Part A, and responders moved to Part B and/or Part C (extension phase) Double-blind Placebo-controlled Single dose (Part A response dose) or placebo B Extension phase Open label design Up to 24 weeks (20 weeks dosing, 4 week wash out) Primary endpoint at 4 weeks C
20 Part B change from baseline systolic blood pressure (n=10) LS Mean+ / - SE Change from Baseline (mmHg) Top-line Phase 2 Results in nOH PARTS A and B: SINGLE ASCENDING DOSE, TD-9855 OR PLACEBO Initial responses observed A Responses reported in majority of patients treated 27 of 34 patients enrolled in Part A showed improvements in SBP and/or standing time Responses observed above 5 mg Confirmation vs. placebo B Statistically significant difference of 30 mmHg at 4 hours post-dose (p = 0.011) Ampreloxetine increased SBP from a low baseline SBP dropped on placebo during day as expected, due to postural changes and eating No evidence of supine hypertension with ampreloxetine overnight SBP: systolic blood pressure.
21 Top-line Phase 2 Results in nOH PART C: REPEAT DOSE EXTENSION PHASE Durability of effect observed out to 4 weeks C 16 of 21 patients (76%) completed four weeks of treatment Reductions in symptom severity, with most pronounced benefit in patients with symptomatic nOH1 Mean reduction in OHSA #1 = 2.4 points at four weeks (n=16) 13 completers had OHSA #1 > 4 points at baseline; mean reduction in group = 3.8 points at four weeks Consistent increases in SBP through four weeks Clinically meaningful increases in standing SBP (7 mmHg or greater) after standing for three minutes at all time points on all weekly clinic visits Generally well tolerated; no serious adverse events assessed as drug-related Positive results including durability of effect provide basis to begin registrational Phase 3 program in symptomatic nOH in early 2019 1 Symptomatic defined as OSHA #1 > 4.
TD-8236 Potential first inhaled non-steroidal anti-inflammatory for moderate-to-severe asthma regardless of Th2 phenotype
23 Small portion of US patients cause high proportion of cost Severe 14% Moderate 16% Severe 61% Moderate 25% 16M diagnosed asthma cases1 Healthcare utilization2 Patient population 4.9M moderate-to-severe diagnosed patients in US1 Current treatments Inhaled steroids, which often fail to control disease Approved biologics affect subsets of patients Burden of disease Acute exacerbations lead to ER visits Uncontrolled symptoms interfere with ability to sleep, work and QOL US medical costs estimated to be $58B3 Disproportionate healthcare utilization by severe and uncontrolled asthmatics High frequency of hospitalizations and increased use of systemic medications 1 © 2018 DR/Decision Resources, LLC. All rights reserved. Reproduction, distribution, transmission or publication is prohibited. Reprinted with permission. 2 Sadatsafavi, M., et al. Can Respir J, 2010 17(2): 74-80. 3 Nurmagambetov, T., et al., Ann Am Thorac Soc. 2018. High Medical and Economic Burden in Uncontrolled Asthma
JAK/STAT cytokines implicated in severe asthma Th2 High Th2 Low IL-4 IL-23/IL-12 IL-13 IL-6 IL-5 IL-27 TSLP IFN- 24 Mixed granulocytic Eosinophilic Neutrophilic Paucigranulocytic Patient heterogeneity in severe asthma Th2 Low Th2 High Bold denotes biologics in development or approved Novel approved biologics address only Th2 high asthma Key treatment needs: Prevention of exacerbations and symptom control for patient population regardless of Th2 phenotype Potential for Inhaled pan-JAKi to Address Needs of Patients Regardless of Th2 Phenotype Simpson JL, et al. Resp 2006;11:54-61. TD-8236 potently inhibits proposed mediators of Th2 high and Th2 low asthma in human cells Program goal: a potent, inhaled, non-steroidal anti-inflammatory with broad activity in airway inflammation 38 19 29 7
Potent pan-JAKi Lung selective Long duration of action 25 Therapeutic Index High TD-8236 levels and long residence time in mouse lung Low levels in blood Time (h) Concentration (g/g, g/mL) TD-8236s profile supports a once-daily inhaled product with minimal systemic exposure TD-8236 is Optimized for Dry Powder Delivery to the Lung
Economic Interest GSKs FDA-approved TRELEGY ELLIPTA (FF/UMEC/VI): First and only once-daily single inhaler triple therapy
GSKs TRELEGY ELLIPTA: Strong Early Trajectory FIRST AND ONLY ONCE-DAILY SINGLE INHALER TRIPLE THERAPY 27 Economic interest in TRELEGY ELLIPTA Upward-tiering royalty of approximately 5.5% - 8.5% of worldwide net sales1 Passive economic interest; no product cost obligations Impressive progress following first approvals in late-2017 Available in 16 countries Filed in China and Japan; 9 additional approvals expected in 2019 Phase 3 asthma study to complete in early 2019 Recent note transaction augments financial strength into 2019 Non-dilutive private placement of $250 million of 9% non-recourse notes Payable by economic interest in TRELEGY ELLIPTA 75% of royalties to debt repayment until repaid 25% of royalties to the Company Immediate cash infusion with retained economics over TRELEGY ELLIPTAs commercial lifespan; proceeds to support key strategic priorities Strongest US ELLIPTA launch to date Source: GSK; IQVIA NPA weekly TRx data. This information is an estimate derived from the use of information under license from the following IQVIA information service: NPA for the period November 2013 through October 2018. IQVIA expressly reserves all rights, including rights of copying, distribution and republication. Launched in US in November 2017. ANORO BREO ARNUITY INCRUSE TRELEGY TRELEGY ELLIPTA is FF/UMEC/VI or fluticasone furoate/umeclidinium/vilanterol; comprised of ICS, LAMA, and LABA, active components of Breo (FF/VI) and Anoro (UMEC/VI). 1 TBPH holds 85% economic interest in upward-tiering royalty stream of 6.5% 10% payable by GSK (net of TRC LLC expenses paid and the amount of cash, if any, expected to be used by TRC pursuant to the TRC LLC Agreement over the next four fiscal quarters). All statements based on publically available information. Trelegy Ellipta jointly managed by GSK and Innoviva (formerly Theravance, Inc.) 0 10,000 20,000 30,000 40,000 50,000 60,000 70,000 80,000 1 2 3 4 5 6 7 8 9 10 11 12 TRx Volume Month Post Launch
Opportunities for Value Creation Upcoming milestones
29 Multiple programs advancing into pivotal studies, underpinned by future potential cash flows from TRELEGY ELLIPTA royalties, potential Janssen milestones and YUPELRITM launch Shading denotes studies planned to begin in respective development stage. Program Pre-clinical Early Proof of Concept Pivotal Collaborator TD-1473 Ulcerative colitis TD-1473 Crohn's disease Ampreloxetine (TD-9855) Symptomatic neurogenic orthostatic hypotension TD-8236 Serious respiratory diseases Gastrointestinal JAKi NSRI Inhaled JAKi Development Pipeline Advancing Forward
Significant existing cash resources to fund strategic priorities2 Focus on Strategic Priorities COMMITMENT TO CREATING TRANSFORMATIONAL MEDICINES 30 1 Economic interest managed by GSK and Innoviva. Innoviva formerly Theravance, Inc. TBPH holds 85% economic interest in upward-tiering royalty stream of 6.5% 10% payable by GSK (net of TRC LLC expenses paid and the amount of cash, if any, expected to be used by TRC pursuant to the TRC LLC Agreement over the next four fiscal quarters). All statements based on publically available information. 2 Pro forma cash of approximately $570M excluding expected 4Q18 loss. Opportunities to Create Transformational Medicines YUPELRITM (revefenacin) Nebulized LAMA in COPD FDA-approved, commercial launch underway TD-1473 Intestinally-restricted JAKi for inflammatory intestinal diseases Phase 2 study in Crohns disease underway and initiating Phase 2b/3 study in ulcerative colitis Ampreloxetine NSRI in symptomatic neurogenic orthostatic hypotension Initiating Phase 3 program TD-8236 Inhaled JAK inhibitor for serious respiratory diseases First in human studies underway Late-stage research New organ-selective projects in the lung, gut, and eye advancing towards clinic Managed by GSK and Innoviva1 Economic Interest TRELEGY ELLIPTA1 (FF/UMEC/VI) Single inhaler triple therapy in COPD Expected regional expansion including approvals in Japan and China Phase 3 CAPTAIN study (asthma) expected to complete in early 2019
About YUPELRITM (revefenacin) inhalation solution YUPELRITM (revefenacin) inhalation solution is a novel once-daily nebulized LAMA approved for the maintenance treatment of COPD in the US. Market research by Theravance Biopharma indicates approximately 9% of the treated COPD patients in the US use nebulizers for ongoing maintenance therapy.1 LAMAs are a cornerstone of maintenance therapy for COPD and YUPELRI is positioned as the first once-daily single-agent bronchodilator product for COPD patients who require, or prefer, nebulized therapy. YUPELRIs stability in both metered dose inhaler and dry powder device formulations suggest that this LAMA could also serve as a foundation for novel handheld combination products. 1 TBPH market research (N = 160 physicians); refers to US COPD patients 31
Theravance Biopharma Announces Alignment of Workforce with Focus on Key Strategic Priorities
DUBLIN, IRELAND January 7, 2019 Theravance Biopharma, Inc. (NASDAQ: TBPH) (Theravance Biopharma or the Company) today announced a reduction in workforce to align with its focus on continued execution of key strategic programs, and advancement of selected late-stage research programs toward clinical development. Theravance Biopharma will reduce its overall headcount by approximately 50 individuals, with affected employees primarily focused on early research or the infrastructure in support of VIBATIV® (telavancin). VIBATIV is a marketed antibiotic recently sold by the Company to Cumberland Pharmaceuticals, Inc.
Our portfolio has evolved over time, most recently with the approval and commercial launch of YUPELRI (revefenacin) plus the advancement of TD-1473 and ampreloxetine (TD-9855) into late-stage development programs. At this juncture, we concluded it was prudent to focus resources on our late-stage research projects and translational science, late-stage development pipeline, and the commercialization of YUPELRITM, said Rick E Winningham,
chairman and chief executive officer of Theravance Biopharma. While we are scaling back our activities in early research, we remain committed to drug discovery as a source of future long-term growth for our organization. In 2019, those efforts will include driving four new, promising organ-selective projects toward first-in-human studies. We want to express our deep appreciation to the employees who are leaving for their significant contribution to the Companys achievements, and we wish them well in their future endeavors.
About Theravance Biopharma
Theravance Biopharma, Inc. (Theravance Biopharma) is a diversified biopharmaceutical company with the core purpose of creating medicines that help improve the lives of patients suffering from serious illness.
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, gut-selective 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 Glaxo Group or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain programs, including Trelegy Ellipta.
For more information, please visit www.theravance.com.
THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.
This press release contains 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. Theravance Biopharma intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to expectations for the repayment of the notes, the expected future commercial performance of Trelegy Ellipta, the Companys strategies, plans and objectives, the Companys regulatory strategies and timing of clinical studies (including the data therefrom), the potential benefits and mechanisms of action of the Companys product and product candidates, the Companys expectations for product candidates through development and potential regulatory approval and commercialization (including their potential as components of combination therapies). These statements are based on the current estimates and assumptions of the management of Theravance Biopharma as of the date of the press release are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance Biopharma to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: delays or difficulties in commencing, enrolling or completing clinical studies, the potential that results from clinical or non-clinical studies indicate the Companys product candidates are unsafe or ineffective (including when our product candidates are studied in combination with other compounds), risks that product candidates do not obtain approval from regulatory authorities, the feasibility of undertaking future clinical trials for our product candidates based on policies and feedback from regulatory authorities, dependence on third parties to conduct clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates and risks of collaborating with or relying on third parties to discover, develop, manufacture and commercialize products. Other risks affecting Theravance Biopharma are described under the heading Risk Factors contained in Theravance Biopharmas Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 8, 2018 and Theravance Biopharmas other filings with the SEC. In addition to the risks described above and in Theravance Biopharmas filings with the SEC, other unknown or unpredictable factors also could affect Theravance Biopharmas results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance Biopharma assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.
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