BIO-TECHNE RELEASES FIRST QUARTER FISCAL 2020 RESULTS

On October 29, 2019 Bio-Techne Corporation (NASDAQ:TECH) reported its financial results for the first quarter ended September 30, 2019 (Press release, Bio-Techne, OCT 29, 2019, View Source [SID1234549985]).

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First Quarter FY2020 Snapshot

First quarter organic revenue increased by 13% (12% reported) to $183.2 million.
GAAP EPS was $0.37 versus $0.45 one year ago. Delivered adjusted earnings per share (EPS) of $1.06, an increase of 8% over the prior year.
Both segments delivered solid double-digit organic growth with Diagnostics and Genomics at 16% and Protein Sciences at 12%.
Construction commenced on a state-of-the-art GMP manufacturing facility to support our expanding cell and gene therapy portfolio.
More than 60 million Medicare beneficiaries will be covered for the ExoDx Prostate IntelliScore (EPI) test on December 1, 2019, upon finalization of the Local Coverage Decision from the Medicare Administrative Contractor.
The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States (GAAP). Adjusted EPS, adjusted earnings, adjusted gross margin, adjusted operating income, and adjusted operating margin are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of non-GAAP Adjusted Financial Measures." A reconciliation of GAAP to non-GAAP financial measures is included in this press release.

"We opened fiscal 2020 posting an outstanding first quarter," said Chuck Kummeth, President and Chief Executive Officer of Bio-Techne. "The 13% organic growth for the quarter was the result of very good execution from our global team and our strong product portfolio, which remains extremely vital in research workflow for our customers."

Kummeth added, "Our end-markets, including BioPharma and Europe, remain healthy, while China continues to outperform at nearly 20% growth. I’m very proud of the team for this excellent start to the year and very optimistic about our future execution and growth due to all the exciting new products and services we offer as a valued partner to researchers worldwide. "

First Quarter Fiscal 2020

Revenue

Net sales for the first quarter increased 12% to $183.2 million. Organic growth was 13% compared to the prior year, with foreign currency exchange having an unfavorable impact of 1% and acquisitions contributing less than 1% to revenue growth.

GAAP Earnings Results

GAAP EPS decreased to $0.37 per diluted share, versus $0.45 in the same quarter last year. GAAP EPS was unfavorably impacted by an unrealized loss on our ChemoCentryx investment. GAAP operating income for the first quarter of fiscal 2020 increased 29.4% to $33.3 million, compared to $25.8 million in the first quarter of fiscal 2019. GAAP operating margin was 18.2%, compared to 15.8% in the first quarter of fiscal 2019. GAAP operating margin compared to prior year was positively impacted by the timing of stock compensation expense recognized as a result of adding new requirements for certain vesting eligibility.

Non-GAAP Earnings Results

Adjusted EPS increased to $1.06 per diluted share, versus $0.98 in the same quarter last year, an increase of 8% resulting from higher sales volumes. Adjusted operating income for the first quarter of fiscal 2020 increased 6% compared to the first quarter of fiscal 2019. Adjusted operating margin was 31.8%, compared to 33.9% in the first quarter of fiscal 2019. Adjusted operating margin compared to the prior year was negatively impacted by recent acquisitions and unfavorable foreign exchange rates.

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the Company’s business segments, as highlighted below. Since these results are used for this purpose, they are also considered to be prepared in accordance with GAAP.

Protein Sciences Segment

The Company’s Protein Sciences segment is one of the world’s leading suppliers of specialized proteins such as cytokines and growth factors, immunoassays, antibodies and reagents, to the biotechnology community. Additionally, the segment provides an array of platforms useful in various areas of protein analysis. Protein Sciences segment’s first quarter fiscal 2020 net sales were $141.0 million, an increase of 12% from $126.4 million for the first quarter of fiscal 2019. Organic growth for the segment was 12%, with foreign currency exchange having an unfavorable impact of 1% on revenue growth and acquisitions contributing 1% to revenue growth. Protein Sciences segment’s operating margin was 42.2% in the first quarter of fiscal 2020 compared to 43.2% in the first quarter of fiscal 2019. The segment’s operating margin compared to the prior year was negatively impacted by product mix and unfavorable foreign exchange.

Diagnostics and Genomics Segment

The Company’s Diagnostics and Genomics segment provides blood chemistry and blood gas quality controls, hematology instrument controls, diagnostics immunoassays and other bulk and custom reagents for the in vitro diagnostic market. The Diagnostics and Genomics segment also develops and provides in situ hybridization products as well as exosome-based diagnostics for various pathologies, including prostate cancer. The Diagnostics and Genomics segment’s first quarter fiscal 2020 net sales were $42.6 million compared to $36.7 million for the first quarter of fiscal 2019. Organic growth for the segment was 16%, with foreign currency exchange having an unfavorable impact of 1% and acquisitions contributing 1%. The Diagnostics and Genomics segment’s operating margin was 2.1% in the first quarter of fiscal 2020 compared to 6.9% in the first quarter of fiscal 2019. The segment’s operating margin was negatively impacted by the acquisition of Exosome which was acquired in August of 2019.

Conference Call

Bio-Techne will host an earnings conference call today, October 29, 2019 at 8:00 a.m. CDT. To listen, please dial 1-888-394-8218 or 1-323-701-0225 for international callers, and reference conference ID 5097333. A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by going to:

View Source

The replay will be available from 11:00 a.m. CDT on Tuesday, October 29, 2019 until 11:00 p.m. CST on Friday, November 29, 2019.

Use of non-GAAP Adjusted Financial Measures:

This press release contains financial measures that have not been calculated in accordance with accounting principles generally accepted in the U.S. (GAAP). These non-GAAP measures include:

Organic growth
Adjusted diluted earnings per share
Adjusted net earnings
Adjusted gross margin
Adjusted operating income
Adjusted operating margin
We provide these measures as additional information regarding our operating results. We use these non-GAAP measures internally to evaluate our performance and in making financial and operational decisions, including with respect to incentive compensation. We believe that our presentation of these measures provides investors with greater transparency with respect to our results of operations and that these measures are useful for period-to-period comparison of results.

Our non-GAAP financial measure of organic growth represents revenue growth excluding revenue from acquisitions within the preceding 12 months as well as the impact of foreign currency. Excluding these measures provides more useful period-to-period comparison of revenue results as it excludes the impact of foreign currency exchange rates, which can vary significantly from period to period, and revenue from acquisitions that would not be included in the comparable prior period.

Our non-GAAP financial measures for adjusted gross margin, adjusted operating margin, and adjusted net earnings, in total and on a per share basis, exclude the costs recognized upon the sale of acquired inventory, amortization of acquisition intangibles, and acquisition related expenses. The Company excludes amortization of purchased intangible assets and purchase accounting adjustments, including costs recognized upon the sale of acquired inventory and acquisition-related expenses, from this measure because they occur as a result of specific events, and are not reflective of our internal investments, the costs of developing, producing, supporting and selling our products, and the other ongoing costs to support our operating structure. Additionally, these amounts can vary significantly from period to period based on current activity.

The Company’s non-GAAP adjusted operating margin and adjusted net earnings, in total and on a per share basis, also excludes stock-based compensation expense, which is inclusive of the employer portion of payroll taxes on those stock awards, restructuring, impairments of equity method investments, gain and losses from investments, and certain adjustments to income tax expense. Stock-based compensation is excluded from non-GAAP adjusted net earnings because of the nature of this charge, specifically the varying available valuation methodologies, subjective assumptions, variety of award types, and unpredictability of amount and timing of employer related tax obligations. Impairments of equity investments are excluded as they are not part of our day-to-day operating decisions. Additionally, gains and losses from other investments that are either isolated or cannot be expected to occur again with any predictability are excluded. Costs related to restructuring activities, including reducing overhead and consolidating facilities, are excluded because we believe they are not indicative of our normal operating costs. The Company independently calculates a non-GAAP adjusted tax rate to be applied to the identified non-GAAP adjustments considering the impact of discrete items on these adjustments and the jurisdictional mix of the adjustments. In addition, the tax impact of other discrete and non-recurring charges which impact our reported GAAP tax rate are adjusted from net earnings. We believe these tax items can significantly affect the period-over-period assessment of operating results and not necessarily reflect costs and/or income associated with historical trends and future results.

Vectura Group appoints New Chief Executive Officer

On October 29, 2019 Vectura Group plc (LSE: VEC) ("Vectura", the "Group", or the "Company"), is reported the appointment of Will Downie as CEO and Executive Director of the Company with effect from 7th November 2019 (Press release, Vectura, OCT 29, 2019, View Source [SID1234549984]).

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Prior to joining Vectura, Will spent ten years as the Senior Vice President, Global Sales and Marketing at Catalent Inc., one of the world’s largest Contract Development and Manufacturing Organisations (CDMO).

In his role at Catalent, Will led the commercial effort and had responsibility for global sales, marketing and commercial operations activities. During his tenure, he developed an outstanding track record in helping drive the long-term growth of the company as well as positioning Catalent as one of the leading brands in the pharmaceutical services space. He has a deep understanding of the development and advanced drug delivery market and has amassed significant experience in driving sustained long-term results, as well as building performance-focused organisations and meeting customer needs on a global scale.

Prior to Catalent, Will held positions as Vice President & General Manager, Global Molecular Imaging at GE Healthcare, Vice President Sales EMEA at Amersham Health and Director of Business Development and Commercial Operations at Quintiles Innovex UK Limited. In his early career, he worked in a range of sales and marketing management positions at both Sanofi and Merck & Co.

Bruno Angelici, Chairman, commented: "I am very pleased to welcome Will Downie as Vectura’s new CEO. He brings a wealth of relevant experience which will help Vectura to grow and deliver on its new strategic focus as a leading inhaled CDMO business.

"I would like to thank Paul Fry for the significant work he has done since stepping into the Interim Chief Executive role and driving the change necessary for Vectura to become a leading player in the inhaled CDMO space. Paul will resume his responsibilities as Chief Financial Officer from 7th November."

Will Downie commented: "I am delighted to have accepted the role of CEO of Vectura and to have the opportunity to expand and build on its reputation as an inhalation device and formulation specialist. I am looking forward to driving the new business strategy and ensuring the Company achieves its long-term goal of becoming a world class CDMO organisation in the inhalation space."

There are no additional details to disclose under Listing Rule 9.6.13 (1) to (6) in respect of the appointment of Will Downie.
-Ends-

For more information, please contact:
Vectura Group plc
David Ginivan – VP Corporate Communications +44 (0)7471 352 720
Elizabeth Knowles – VP Investor Relations +44 (0)7767 160 565

Consilium Strategic Communications
Mary-Jane Elliott / Sue Stuart / David Daley +44 (0)20 3709 5700

Xencor to Host Third Quarter 2019 Financial Results Webcast and Conference Call on November 5, 2019

On October 29, 2019 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer, autoimmune diseases, asthma and allergic diseases, reported that it will release third quarter 2019 financial results after the market closes on Tuesday, November 5, 2019 (Press release, Xencor, OCT 29, 2019, View Source [SID1234549983]).

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Xencor management will host a webcast and conference call the same day at 4:30 p.m. ET (1:30 p.m. PT) to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing (877) 359-9508 for domestic callers or (224) 357-2393 for international callers and referencing conference ID number 9415077. A live webcast of the conference call will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. The webcast will be archived on the company website for 30 days.

Phio Pharmaceuticals to Highlight Self-delivering RNAi Technology at SITC 2019

On October 29, 2019 Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported that several posters featuring INTASYL will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2019 Annual Meeting, held November 6-10 at the Gaylord National Hotel and Convention Center in National Harbor, MD (Press release, Phio Pharmaceuticals, OCT 29, 2019, View Source [SID1234549982]). Three posters, reflecting internal work and work in collaboration with Iovance Biotherapeutics, Inc. and the Karolinska Institutet, will be highlighting Phio’s proprietary INTASYL technology for "weaponizing" T cells against cancer.

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Presentation Details:

Poster: P149
Date: Friday November 8, 2019
Title: Silencing PD-1 using self-delivering RNAi PH-762 to improve Iovance TIL effector function using Gen 2 manufacturing method
Category: Cellular Therapies
Authors: Inbar Azoulay-Alfaguter, PhD; Michelle R. Abelson, PhD; Krit Ritthipichai, DVM, PhD; Kenneth D’Arigo; Florangel Hilton; Marcus Machin, BS; Dingxue Yan; James Cardia; Maria Fardis, PhD, MBA; Cecile Chartier

Poster: P222
Date: Saturday November 9, 2019
Title: Modulating BRD4 in T cells using self-delivery RNAi to improve adoptive cell therapy of cancer
Category: Cellular Therapies
Authors: Jeroen Melief, PhD; Laura L. Van Leeuwe Kirsch, BSc; Esmeralda Hemme; John A. Barrett, PhD; Simon P. Fricker, PhD; Gerrit Dispersyn, PhD; Rolf Kiessling, MD, PhD

Poster: P760
Date: Saturday November 9, 2019
Title: Local modulation of T cell PD-1 using self-delivering RNAi as a potential immunotherapeutic
Category: Novel Single-Agent Immunotherapies
Authors: John A. Barrett, PhD; James Cardia; Melissa Maxwell; Mani D. Kadiyala, M.S.; Dingxue Yan, PhD; Winnie Tam; Simon P. Fricker, PhD; Gerrit Dispersyn, PhD

Cassava Sciences Announces Recent Clinical Highlights and Third Quarter 2019 Financial Results

On October 29, 2019 Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biopharmaceutical company focused on Alzheimer’s disease, reported recent clinical highlights and reported financial results for the third quarter ended September 30, 2019 (Press release, Pain Therapeutics, OCT 29, 2019, View Source [SID1234549981]).

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Net loss for the third quarter 2019 was $0.7 million, or $0.04 per share, as compared to a net loss of $1.3 million, or $0.11 per share, for the same period in 2018. Net cash used was $0.7 million during the third quarter of 2019. Cassava Sciences ended the third quarter 2019 with $17.8 million of cash and equivalents, and no debt.

"Cassava Sciences had a productive quarter with our clinical research program in Alzheimer’s," said Remi Barbier, President & CEO. "We are encouraged by the robust biomarker data from a Phase 2a study in Alzheimer’s with lead drug candidate, PTI-125. PTI-125 is a twice-daily oral drug that targets both the neurodegeneration and the inflammatory components of Alzheimer’s. We’re seeing the research community shift from an amyloid-centric view, with all its noise and confusion, to one that targets neurodegeneration and neuroinflammation. PTI-125’s mechanism of action supports this evolution in Alzheimer’s drug development. That gets us excited."

Clinical Highlights

In September, Cassava Sciences reported positive clinical results in Alzheimer’s disease with its lead drug candidate, PTI-125. In a first-in-patient, Phase 2a study funded by the National Institutes of Health (NIH), treatment with PTI-125 for 28 days significantly reduced biomarkers of disease pathology, neuroinflammation and neurodegeneration, consistent with years of basic research and pre-clinical data.

Key results of the Phase 2a study include: total tau (T-tau) decreased 20% (p<0.001); phosphorylated tau (P-tau) decreased 34% (p<0.0001); neurofilament light chain (NfL), a marker for neurodegeneration, decreased 22% (p<0.0001); neurogranin, a marker for cognitive decline, decreased 32% (p<0.0001); and neuroinflammatory marker YKL-40, an indicator of microglial activation, decreased 9% (p<0.0001). We believe these and other data provide evidence of target engagement in patients with Alzheimer’s disease.

All evaluable patients showed a biomarker response to PTI-125. The drug was well tolerated, with no observable drug-related adverse events.

As a result of positive clinical results from its Phase 2a study of PTI-125, Cassava Sciences recently initiated a Phase 2b study. This Phase 2b is designed to evaluate safety, tolerability and drug effects of PTI-125 in Alzheimer’s disease. This blinded, randomized, placebo-controlled, oral dose study will enroll approximately 60 patients with mild-to-moderate Alzheimer’s disease. Patients will be dosed with PTI-125 100 mg, 50 mg or matching placebo, twice daily for 28 continuous days. The primary endpoint is improvement in biomarkers of neurodegeneration and neuroinflammation from baseline to Day 28. The study is supported by a clinical research grant award from NIH.

In October, Cassava Sciences announced that results of its Phase 2a study of PTI-125 were selected for a late-breaking oral presentation by the 12th International Conference on Clinical Trials on Alzheimer’s Disease (CTAD), which takes place December 4-7th, 2019.
Financial Highlights

At September 30, 2019, cash and cash equivalents were $17.8 million, compared to $19.8 million at December 31, 2018, with no debt.
Cash used was $0.7 million during the third quarter of 2019, net of reimbursements received from NIH.

Net cash use for full year 2019 is expected to be $3.0 – $5.0 million, consistent with previous financial guidance.

Net loss for the third quarter 2019 was $0.7 million, or $0.04 per share, as compared to a net loss of $1.3 million, or $0.11 per share, for the same period in 2018.
Research grant funding reimbursements of $1.5 million from NIH were recorded as a reduction in research and development expenses (R&D). This compared to $1.1 million of NIH grant receipts received for the same period in the prior year.
R&D expenses, after deducting the grant reimbursement, were negative $0.1 million. This compared to $0.4 million for the same period in the prior year, representing a 112% decrease. The decrease was due primarily to an increase in NIH grant funding in 2019 compared to the prior year, combined with a decrease in non-cash stock-based compensation expense.
General and administrative expenses were $0.8 million, consistent with the same period in 2018.
About PTI-125 and Cassava Sciences’ Scientific Approach
The target of PTI-125 is an altered form of filamin A (FLNA), a scaffolding protein. Published studies have shown that altered FLNA in the brain disrupts the normal function of neurons, leading to Alzheimer’s pathology, neurodegeneration and neuroinflammation. Cassava Sciences’ lead drug candidate, PTI-125, is a small molecule that restores the normal shape and function of FLNA in the brain. This action improves the function of certain receptors in the brain and exerts powerful anti-neuroinflammatory effects.

Cassava Sciences is also developing an investigational diagnostic to detect Alzheimer’s disease with a simple blood test. This program, called PTI-125Dx, also receives significant scientific and financial support from NIH.

The underlying science for Cassava Sciences’ programs in neurodegeneration is published in several prestigious peer-reviewed technical journals, including Journal of Neuroscience, Neurobiology of Aging, and Journal of Biological Chemistry. As previously announced, NIH has awarded Cassava Sciences two research grants following an in-depth, confidential review of its science and technology. These two grant awards represent up to $6.7 million of non-dilutive financing.

About Alzheimer’s Disease
Alzheimer’s disease is a progressive brain disorder that destroys memory and thinking skills. Currently, there are no drug therapies to halt Alzheimer’s disease, much less reverse its course. In the U.S. alone, approximately 5.8 million people are currently living with Alzheimer’s disease, and approximately 487,000 people age 65 or older will develop Alzheimer’s in 2019.1 The number of people living with Alzheimer’s disease is expected to grow dramatically in the years ahead, which may also result in a growing social and economic burden.2

1, 2 Source: Alzheimer’s Association. 2019 Alzheimer’s Disease Facts and Figures. Available online at: View Source