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Theravance Biopharma, Inc. Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Business Update

On February 26, 2019 Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) reported financial results for the fourth quarter and full year ended December 31, 2018 (Press release, Theravance, FEB 26, 2019, View Source [SID1234533700]). Revenue for the fourth quarter and full year 2018 was $15.7 million and $60.4 million, respectively. Full year operating loss was $238.8 million or $187.4 million excluding share-based compensation expense, in line with the Company’s previously stated financial guidance. Cash, cash equivalents, and marketable securities totaled $517.1 million as of December 31, 2018.

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Rick E Winningham, chairman and chief executive officer, commented: "Following a highly productive 2018, we begin the year with great momentum and continue to make meaningful progress towards our goal of designing more effective and safer medicines to address unmet patient needs. Early in 2018, we entered into a global collaboration with Janssen for TD-1473, our gut-selective pan-JAK inhibitor for inflammatory intestinal diseases, for which we are beginning late-stage clinical trials. In the middle of the year, we showed positive four-week results for ampreloxetine in neurogenic orthostatic hypotension, providing us with the confidence to advance into a registrational Phase 3 program which is now underway. In the latter part of 2018, we and our partner Mylan achieved product approval for YUPELRI in COPD, and formal launch efforts are now underway. We closed out the year with R&D Day where we described our innovative research and development strategy of organ-selective medicines designed to expand the therapeutic index beyond that of conventional therapy and introduced several new research programs. Underpinning the progress of our own business, GSK’s TRELEGY ELLIPTA for COPD continues its impressive sales trajectory, and we await the results of the Phase 3 CAPTAIN study in asthma in the first half of 2019.

"We anticipate multiple clinical readouts and milestones over the next several months, including supplemental data presentations at upcoming scientific meetings for TD-1473 in ulcerative colitis and ampreloxetine in nOH, as well as Phase 1 data for TD-8236, and initial commercial metrics for YUPELRI. Following our recently completed note financing tied to our economic interest in TRELEGY ELLIPTA, we enter 2019 with a strong cash balance and are well-positioned to execute against our milestones and continue to deliver value to stakeholders."

Program and Corporate Updates

YUPELRITM (revefenacin) inhalation solution (lung-selective nebulized long-acting muscarinic antagonist (LAMA)):

First and only once-daily, nebulized bronchodilator approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Formal launch activities underway with partner Mylan; combined sales infrastructures covering the hospital, hospital discharge, and home health settings
TD-1473 (gut-selective pan-Janus kinase (JAK) inhibitor):

First patients dosed in Phase 2 DIONE induction study in Crohn’s disease
Sites initiated in registrational Phase 2b/3 RHEA induction and maintenance study in ulcerative colitis
Results from the Phase 1b study of TD-1473 in patients with ulcerative colitis accepted as an oral presentation at Digestive Disease Week (DDW) in May 2019
Ampreloxetine (TD-9855, norepinephrine reuptake inhibitor (NRI)):

Recently announced initiation of dosing in registrational Phase 3 program in symptomatic neurogenic orthostatic hypotension (nOH)
Phase 2 study in patients with nOH complete; 5-month data further support previously-announced clinical observations after four weeks of treatment. Detailed study data to be submitted for presentation at mid-year scientific meeting
TD-8236 (novel, lung-selective inhaled pan-JAK inhibitor for serious respiratory diseases):

Discovery leverages organizational expertise in respiratory diseases and JAK inhibition
Phase 1 clinical study underway; designed to evaluate safety and provide biomarker data of TD-8236 in healthy volunteers and asthma patients; completion expected in mid-2019
Multiple JAK-dependent pathways clinically validated in asthma and COPD
Potentially broad activity with JAK inhibition across a range of respiratory indications and phenotypes
TD-8236 shown to potently inhibit targeted mediators of Th2-high and Th2-low asthma in human cells in preclinical studies
R&D Day in December 2018:

Highlighted our innovative research and development strategy of organ-selective medicines and introduced several new research programs that we plan to advance towards clinical development, each specifically tailored to the organ of interest
TRELEGY ELLIPTA (first once-daily single inhaler triple therapy for COPD)1:

GSK reported fourth quarter 2018 net sales of $100 million and $207 million for the full year 2018; Theravance Biopharma entitled to approximately 5.5% to 8.5% (tiered) of worldwide net sales of the product
Currently available in 26 countries, with additional countries expected over the course of 2019; recent regulatory filings include Japan and China
Expanded COPD indication in Europe for patients not adequately treated with dual bronchodilation, making it the first single inhaler triple therapy indicated for patients with moderate to severe COPD
Completion of Phase 3 CAPTAIN study in asthma patients expected in 1H 2019; if positive, submission of supplemental New Drug Application (sNDA) for TRELEGY ELLIPTA in asthma anticipated in 2H 2019
Completed a non-dilutive private placement of $250.0 million in aggregate principal amount of non-recourse notes secured by a portion of the future payments the Company expects to receive related to royalties due on net sales1 of TRELEGY ELLIPTA
75% share of the payments will be used to satisfy the debt obligations until notes repaid
Remaining 25% of the payments will be directed to benefit the Company on an ongoing basis
Proceeds were approximately $229.0 million net of debt issuance costs and a 5% retention of the notes by the Company
Strategic infusion of cash in late 2018 with retained economics over TRELEGY ELLIPTA’s commercial lifespan; proceeds to support key strategic priorities
VIBATIV (telavancin): Sale of VIBATIV to Cumberland Pharmaceuticals Inc. completed in November 2018

Notes:
1 As reported by Glaxo Group Limited or one of its affiliates (GSK); reported sales converted to USD; economic interest related to TRELEGY ELLIPTA (the combination of fluticasone furoate, umeclidinium, and vilanterol, (FF/UMEC/VI), jointly developed by GSK and Innoviva, Inc.) entitles Company to upward tiering payments equal to approximately 5.5% to 8.5% on worldwide net sales of the product (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)

Fourth Quarter and Full Year Financial Results

Revenue

Revenue for the fourth quarter of 2018 was $15.7 million, comprised of collaboration revenue primarily related to our global collaboration with Janssen for TD-1473 of $10.0 million, profit sharing revenue related to YUPELRI of $3.3 million, and product sales of VIBATIV (telavancin) of $2.4 million. Revenue in the fourth quarter represents an increase of approximately $11.2 million over the same period in 2017. The increase was primarily related to revenue recognized from the upfront payment associated with the global collaboration agreement with Janssen for TD-1473. The increase was partially offset as a full quarter of Product Sales was not recognized due to the sale of VIBATIV to Cumberland Pharmaceuticals in November 2018. Full year 2018 revenue was $60.4 million, comprised of collaboration revenue of $41.8 million primarily associated with the upfront payment from Janssen for TD-1473, product sales of VIBATIV of $15.3 million and profit sharing revenue related to YUPELRI of $3.3 million.

Research and Development (R&D) Expenses

R&D expenses for the fourth quarter of 2018 were $52.3 million, compared to $51.1 million in the same period in 2017. The increase was primarily due to higher external expenses to support our key programs and was partially offset by lower employee-related and share-based compensation expenses. Full year 2018 R&D expenses were $201.3 million, or $175.8 million excluding non-cash share-based compensation.

Selling, General and Administrative (SG&A) Expenses

SG&A expenses for the fourth quarter of 2018 were $25.5 million, compared to $29.5 million in the same period in 2017. The decrease was primarily due to lower expenses related to share-based compensation. Full year 2018 SG&A expenses were $97.1 million, or $71.3 million excluding non-cash share-based compensation.

Cash, Cash Equivalents and Marketable Securities

Cash, cash equivalents and marketable securities totaled $517.1 million as of December 31, 2018, which includes net proceeds of $229.4 million resulting from the private placement of notes secured by a portion of the future payments related to royalties due on net sales of TRELEGY ELLIPTA.

2019 Financial Guidance

The Company expects full-year 2019 operating loss, excluding share-based compensation, of $210 million to $230 million. Operating loss guidance does not include royalty income for TRELEGY ELLIPTA which we recognize in our statement of operations as "income from investment in TRC, LLC." Our share of US profits and losses related to the commercialization of YUPELRI, potential future business development collaborations as well as the timing and cost of clinical studies associated with our key programs, among other factors, could impact our financial guidance.

Conference Call and Live Webcast Today at 5:00 pm ET

Theravance Biopharma will hold a conference call and live webcast accompanied by slides today at 5:00 pm ET. To participate in the live call by telephone, please dial (855) 296-9648 from the US, or (920) 663-6266 for international callers, and use the confirmation code 8086288. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma’s website at www.theravance.com, under the Investor Relations section, Presentations and Events. Please go to the website 15 minutes prior to the start of the call to register, download, and install any necessary audio software.

A replay of the conference call will be available on Theravance Biopharma’s website for 30 days through March 28, 2019. An audio replay will also be available through 8:00 pm ET on March 5, 2019 by dialing (855) 859-2056 from the U.S., or (404) 537-3406 for international callers, and then entering confirmation code 8086288.

Selexis SA and Turgut Pharmaceuticals Expanding Biosimilar Development Relationship by Signing Two Brand License Agreements

On February 26, 2019 Selexis SA and Turgut Pharmaceuticals (Turgut Ilaclari AS) reported that they have signed two trademark license agreements (CLMs) through which Turgut will operate the SURE Technology Platform and SURE CHO-M Cell Line by Selexis for the development of two high-end biosimilar antibodies: a control point inhibitor for the treatment of certain cancers and a monoclonal antibody for the treatment of HER2-positive metastatic breast cancer (Press release, Selexis FEB 26, 2019, View Source [SID1234533699]). With the addition of these CLMs, companies are now collaborating on the development of multiple biosimilars for cancer and inflammatory diseases. The companies announced the signing of the most recent CLMs in December 2017 .

"In just under three years, we have signed five brand license agreements, in collaboration with the Turgut team, to advance its high-end biosimilar pipeline. Our technology and our cell line have proven their impact on biosimilar development, which is very important given the huge demand to offer patients expanded access to life-changing organic products, "said Marco Bocci., PhD at DPharm, Vice President of Licensing and Business Development at Selexis. "Turgut shares our passion for bringing advanced medicines to patients faster and at a lower cost. The success we have had with Turgut so far has been fueled by our collaboration and we are very pleased to continue supporting their efforts to bring biosimilars to the market under these new licenses. "

Selexis’ proprietary SURE technology platform facilitates the rapid, stable and cost-effective production of virtually all recombinant proteins, including biosimilars, and provides a seamless integration of the organic product development continuum, from discovery to commercialization. Using the SURE technology platform, Selexis has managed to generate many biosimilars, including marketed products, whose glycan profiles correspond to the originator drugs.

"These two products are innovative treatments that can improve accessibility for a much larger patient population," said Serdar Alpan, MD, PhD, head of the Biotechnology Group at Turgut Pharmaceuticals. "As a cell line development specialist and Turgut’s strong partner, Selexis’ tools and technologies provide us with the competitiveness we need to move forward on our biosimilar programs. We look forward to moving these programs forward. "

The SURE CHO-M cell line from Selexis is a high performance mammalian cell line derived from CHO-K1 cells and used for the production of recombinant therapeutic proteins and monoclonal antibodies. The growth and production properties of the Selexis SURE CHO-M cell line are well defined and the feeding strategy has been optimized to allow for faster and more efficient scaling of the bioreactors. Therapies generated with Selexis SURE CHO-M cells undergo clinical trials and are transformed into marketed products.

Five Prime Therapeutics Reports Fourth Quarter and Full Year 2018 Financial Results

On February 26, 2019 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported its financial results for the fourth quarter and year ended December 31, 2018, in addition to providing an update on the company’s recent activities (Press release, Five Prime Therapeutics, FEB 26, 2019, View Source [SID1234533698]).

"2018 was a year of significant expansion of our clinical pipeline," said Aron Knickerbocker, Chief Executive Officer of Five Prime Therapeutics. "Thanks to strong execution across our research, preclinical and clinical organizations, along with the contributions of the entire Five Prime team, we are positioned for a year of multiple data readouts. We began 2019 in a strong position with five assets in clinical development as well as the capital and support from our collaborators required to achieve our goals. By the end of 2019, we expect the bema FIGHT Phase 3 to be enrolling across nearly 200 sites globally and to disclose data from FPA150 and FPT155 that will inform the clinical path forward for these first-in-class programs. In addition, we are pleased with the continued progress of our BMS-partnered cabira and TIM-3 programs."

Review of 2018 Business Highlights and 2019 Milestones

Clinical Pipeline:

Bemarituzumab (FPA144) is a first-in-class isoform-selective antibody with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) in development as a targeted immuno-therapy for tumors that overexpress FGFR2b.

2018

Completed the Phase 1 safety lead-in and dosed the first patient in the randomized Phase 3 FIGHT global registration trial.
2019

Presented safety lead-in data from the Phase 3 FIGHT trial at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium. Trial results showed no dose-limiting toxicities and no impact to the pharmacokinetics of bemarituzumab from the combination of mFOLFOX6 plus bemarituzumab. Signs of clinical activity from the combination were observed in each of the two patients with advanced gastric or gastroesophageal junction (GEJ) cancer who were biomarker-positive.
Expect to open approximately 200 clinical sites in 18 countries in the Phase 3 FIGHT trial by year end. The Phase 3 FIGHT trial is a pivotal global registration trial evaluating bemarituzumab in combination with mFOLFOX6 chemotherapy as front-line treatment of patients with gastric or GEJ cancer that overexpresses FGFR2b.
FPA150 (anti-B7-H4) is a first-in-class anti-B7-H4 antibody designed to target tumor cells by blocking B7-H4 from sending an inhibitory signal to CD8 T cells and by enhancing killing of B7-H4 overexpressing tumors through ADCC. B7-H4 is frequently overexpressed in breast, ovarian and endometrial cancers.

2018

Initiated the Phase 1a monotherapy dose escalation portion of a Phase 1a/1b clinical trial of FPA150 in solid tumors.
Initiated patient dosing in the exploratory cohort of the ongoing Phase 1a portion of the trial to enroll patients with tumors that overexpress B7-H4, as assessed by an immunohistochemistry (IHC) assay.
2019

Completed the Phase 1a monotherapy dose escalation portion of the Phase 1a/1b trial.
Initiated the Phase 1b monotherapy expansion cohorts at the selected 20 mg/kg dose given every three weeks, enrolling patients with breast, ovarian, and endometrial tumors with B7-H4 overexpression.
Plan to present data from the Phase 1a/1b trial at the ASCO (Free ASCO Whitepaper) Annual Meeting in June and the European Society for Medical Oncology’s (ESMO) (Free ESMO Whitepaper) 2019 Annual Congress in September.
FPT155 (CD80-Fc) is a first-in-class CD80-Fc fusion protein that uses the binding interactions of soluble CD80 to directly engage CD28 to enhance its co-stimulatory T cell activity without inducing super agonism and to block CTLA-4 from competing for endogenous CD80, allowing CD28 signaling to prevail in T cell activation in the tumor microenvironment.

2018

Initiated patient dosing in a Phase 1a/1b clinical trial of FPT155. The Phase 1a dose escalation portion of the trial will characterize the safety and pharmacokinetic (PK)/pharmacodynamic (PD) profile of FPT155 to identify a recommended dose for the Phase 1b portion of the trial.
2019

Plan to present data from the Phase 1a dose escalation at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November.
Cabiralizumab (FPA008) is an antibody that inhibits CSF1R and has been shown to block the activation and survival of tumor-associated macrophages.

2018

Bristol-Myers Squibb Company (BMS) initiated a multi-arm, Phase 2 clinical trial (NCT03336216) evaluating cabiralizumab in combination with Opdivo, triggering a $25 million milestone payment to Five Prime.
2019

The Phase 2 trial is currently enrolling patients across sites in the U.S., Canada, Europe, Japan, Korea and Taiwan, and is expected to enroll approximately 160 patients with locally advanced or metastatic pancreatic cancer that has progressed during or after one line of chemotherapy.
BMS-986258 (anti-TIM-3) is a fully-human monoclonal antibody targeting TIM-3 (T cell immunoglobulin and mucin domain-3), an immune checkpoint receptor that may limit the duration and magnitude of T cell responses. This is the first clinical candidate from the discovery collaboration between Five Prime and BMS that includes targets in three immune checkpoint pathways.

2018

BMS initiated the Phase 1 portion of the Phase 1/2 clinical trial of BMS-986258 as a single agent as well as in combination with Opdivo or hyaluronidase, with the objective of evaluating the safety and tolerability of the combination with Opdivo.
2019

Continued progress in the Phase 1/2 clinical trial.
Corporate Highlights

2018

Raised net proceeds of $107.6 million from a public offering of 5,897,435 shares of common stock, including 769,230 shares sold upon the underwriters’ full exercise of their option to purchase additional shares.
2019

Announced a corporate restructuring to focus resources on clinical development and late-stage research programs, primarily eliminating positions in research, pathology, and manufacturing.
Summary of Financial Results and Guidance:

Cash Position: Cash, cash equivalents and marketable securities totaled $270.1 million as of December 31, 2018, compared to $292.7 million as of December 31, 2017. The decrease was primarily attributable to cash used in operating activities which was offset in part by the $107.6 million in net proceeds from the public offering of Five Prime’s common stock in January 2018.

Revenue: Collaboration and license revenue for the fourth quarter of 2018 decreased by $9.2 million, or 70%, to $4.0 million from $13.2 million for the fourth quarter of 2017. The decrease was primarily due to Five Prime’s recognition in the fourth quarter of 2017 of a $5.0 million milestone payment received from BMS under the immuno-oncology research collaboration, lower revenue under the cabiralizumab collaboration agreement with BMS, and lower research and development funding from several older collaboration agreements, partially offset by an increase from Five Prime’s collaboration with Zai Lab.

Collaboration and license revenue for the year ended December 31, 2018 increased by $10.4 million, or 26%, to $49.9 million from $39.5 million for the year ended December 31, 2017. This increase was primarily due to $25.0 million of revenue recognized under Five Prime’s cabiralizumab collaboration agreement with BMS for BMS’s achievement of the developmental milestone for the dosing of the first patient in the Phase 2 clinical trial of cabiralizumab in combination with Opdivo, and an increase from Five Prime’s collaboration with Zai Lab that was partially offset by lower research and development funding from several older collaboration agreements.

R&D Expenses: Research and development expenses for the fourth quarter of 2018 increased by $2.0 million, or 6%, to $34.7 million from $32.7 million primarily due to increased clinical expenses associated with the FIGHT trial and FPA150 program, partially offset by lower companion diagnostic development costs.

Research and development expenses for the year ended December 31, 2018 increased by $5.4 million, or 4%, to $156.3 million from $150.9 million for the year ended December 31, 2017. This increase was primarily related to milestone payments associated with the first patient dosed in Five Prime’s Phase 3 FIGHT trial and companion diagnostic development costs that were partially offset by lower manufacturing and preclinical expenses.

G&A Expenses: General and administrative expenses for the fourth quarter of 2018 decreased by $0.9 million, or 9%, to $9.6 million from $10.5 million, primarily due to lower compensation expenses. General and administrative expenses for the year ended December 31, 2018 were $39.7 million, which were essentially flat with the prior year.

Net Loss: Net loss for the fourth quarter of 2018 was $38.8 million, or $1.12 per basic and diluted share, compared to a net loss of $29.2 million, or $1.04 per basic and diluted share for the fourth quarter of 2017.

Net loss for the full year 2018 was $140.4 million, or $4.13 per basic and diluted share, compared to a net loss of $150.2 million, or $5.38 per basic and diluted share, for the full year 2017.

Shares Outstanding: Total shares outstanding were 34,745,721 as of December 31, 2018.

Cash Guidance: Five Prime expects full-year 2019 net cash used in operating activities to be between $117 and $122 million and estimates ending 2019 with cash, cash equivalents and marketable securities between $148 and $153 million.

Conference Call Information

Five Prime will host a conference call and live audio webcast today at 4:30 p.m. (ET) / 1:30 p.m. (PT) to discuss its financial results and provide a corporate update. To participate in the conference call, please dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID 9689855. To access the live webcast please visit the "Events & Presentations" page under the "Investors" tab on Five Prime’s website at www.fiveprime.com. An archived copy of the webcast will be available on Five Prime’s website beginning approximately two hours after the conference call. Five Prime will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.

AngioDynamics to Present at the Barclays Global Healthcare Conference

On February 26, 2019 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that Jim Clemmer, President and Chief Executive Officer, and Michael C. Greiner, Executive Vice President and Chief Financial Officer, will present at the Barclays Global Healthcare Conference at 4:20 p.m. ET on Wednesday, March 13, 2019 in Miami Beach, FL (Press release, AngioDynamics, FEB 26, 2019, View Source [SID1234533697]).

A live webcast of the presentation will be accessible through the "Investors" section of the Company’s website at www.angiodynamics.com and will be available for replay following the event.

Quanterix to Release Fourth Quarter and Full Year 2018 Financial Results and Host Conference Call on Thursday, March 7, 2019

On February 26, 2019 Quanterix Corporation (NASDAQ:QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, reported that it will release its financial results for fourth quarter and full year 2018 after the close of trading on Thursday, March 7, 2019 (Press release, Quanterix, FEB 26, 2019, View Source [SID1234533696]). Company management will host a conference call at 4:30 p.m., ET to discuss Quanterix’ financial results and provide a business update. The call will be hosted by Kevin Hrusovsky, Chief Executive Officer, President and Chairman, Quanterix.

Individuals interested in listening to the conference call may do so by dialing (833) 686-9351 for domestic callers, or (612) 979-9890 for international callers. Please reference the following conference ID: 3288482. A live webcast will be accessible on the investor relations section of Quanterix’ website: View Source The webcast will be available on the Company’s website for one year following completion of the call.