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Cardinal Health Reports First Quarter Results for Fiscal Year 2020

On November 7, 2019 Cardinal Health (NYSE: CAH) reported first quarter fiscal year 2020 revenue of $37.3 billion, an increase of 6 percent from the first quarter last year (Press release, Cardinal Health, NOV 7, 2019, View Source [SID1234550701]).

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First quarter GAAP operating loss was $5.3 billion and included a $5.6 billion accrual related to opioid litigation. Non-GAAP operating earnings increased 6 percent to $577 million. GAAP diluted loss per share was $16.65, while non-GAAP diluted earnings per share (EPS) decreased 2 percent to $1.27.

"We are off to a solid start to fiscal year 2020, giving us confidence in our operating rigor and path forward," said Mike Kaufmann, CEO of Cardinal Health. "Our disciplined cost management is enabling strategic investment across the enterprise. We recognize that as our industry and the healthcare sector continue to evolve, there is more work to be done. Our core capabilities, deep industry knowledge and scale position us to adapt and deliver long-term shareholder value."

Q1 FY20 summary

Q1 FY20

Q1 FY19

Y/Y

Revenue

$37.3 billion

$35.2 billion

Operating earnings/(loss)

$(5.3) billion

$816 million

N.M.

Non-GAAP operating earnings

$577 million

$542 million

Net earnings/(loss) attributable
to Cardinal Health, Inc.

$(4.9) billion

$593 million

N.M.

Non-GAAP net earnings attributable
to Cardinal Health, Inc.

$378 million

$396 million

(4)%

Diluted EPS/(loss per share)
attributable to Cardinal Health, Inc.2

$(16.65)

$1.94

N.M.

Non-GAAP diluted EPS attributable
to Cardinal Health, Inc.

$1.27

$1.29

(2)%

Segment results

Pharmaceutical segment

Q1 FY20

Q1 FY19

Y/Y

Revenue

$33.4 billion

$31.4 billion

Segment profit

$398 million

$409 million

(3)%

First quarter revenue for the Pharmaceutical segment increased 6 percent to $33.4 billion due to sales growth from Pharmaceutical Distribution and Specialty Solutions customers.

Pharmaceutical segment profit decreased 3 percent to $398 million in the first quarter, which reflects the adverse impact of Pharmaceutical Distribution customer contract renewals, partially offset by benefits from cost savings initiatives and the performance of Specialty Solutions.

Medical segment

Q1 FY20

Q1 FY19

Y/Y

Revenue

$3.9 billion

$3.8 billion

Segment profit

$170 million

$135 million

26%

First quarter revenue for the Medical segment increased 3 percent to $3.9 billion due to organic growth across the segment, led by products and distribution, and Cardinal Health at Home. This was partially offset by the divestiture of the naviHealth business.

Medical segment profit increased 26 percent to $170 million in the first quarter, which reflects the benefits from cost savings initiatives, as well as growth in products and distribution, services, and Cardinal Health at Home. This was partially offset by the divestiture of the naviHealth business.

Outlook

The company does not provide a GAAP EPS outlook because it is unable to reliably forecast most of the items that are excluded from GAAP EPS to calculate non-GAAP EPS. These items could cause EPS to differ materially from non-GAAP EPS. See "Use of Non-GAAP Measures" following the attached schedules for additional explanation.

The company reaffirms its fiscal year 2020 guidance range for non-GAAP diluted earnings per share attributable to Cardinal Health, Inc. of $4.85 to $5.10.

Opioid lawsuits developments

In October 2019, the company agreed in principle to a global settlement framework with a leadership group of four state attorneys general that is designed to resolve all pending and potential opioid lawsuits by states and political subdivisions. The global settlement framework includes, among other significant components, an agreement in principle by the company to pay up to $5.56 billion over 18 years. There is no assurance that a definitive settlement agreement will be finalized by the necessary parties or that the contingencies to any agreement will be satisfied. The company also agreed to a $66 million settlement with two Ohio counties. In connection with these matters, the company accrued $5.63 billion ($5.14 billion after tax) which is excluded from its non-GAAP earnings.

Quarterly dividend

Cardinal Health board of directors approved a quarterly dividend of $0.4811 per share. The dividend will be payable on January 15, 2020 to shareholders of record at the close of business on January 2, 2020.

Tax rate

During the first quarters of fiscal 2020 and 2019, GAAP effective tax rates were 7.9 percent and 19.4 percent, respectively. Non-GAAP effective tax rates were 23.7 percent and 14.0 percent, respectively.

The GAAP effective tax rate for the first quarter of fiscal 2020 was impacted by the assessment of the future deductibility of the $5.6 billion opioid litigation accrual.

The effective tax rates in the first quarter of fiscal 2019 were affected by an approximately $0.18 per share positive impact of discrete tax benefits primarily related to international legal entity changes.

Webcast

Cardinal Health will host a webcast today at 8 a.m. Eastern to discuss first quarter results. To access the webcast and corresponding slide presentation, go to the Investor Relations page at ir.cardinalhealth.com. No access code is required.

Presentation slides and a webcast replay will be available until November 6, 2020.

Upcoming webcasted investor events

Credit Suisse 28th Annual Healthcare Conference on November 12 at 2:25 p.m. Mountain in Scottsdale, Ariz.
38th Annual J.P. Morgan Healthcare Conference on January 13-16, 2020 in San Francisco, Calif.

TOT BIOPHARM (1875.HK) Proceeded with IPO raising over HK$500 million

On November 7, 2019 TOT BIOPHARM International Company Limited ("TOT BIOPHARM" or the "Company", reported together with its subsidiaries, the "Group", stock code: 1875) was well received by the capital market and should be the eleventh 18A Biotech company listed in Hong Kong since the inception of the new listing regulation last year (Press release, Tot Biopharm, NOV 7, 2019, View Source [SID1234550717]).

The Company’s shares will commence trading on the Main Board of The Stock Exchange of Hong Kong Limited at 9:00 a.m. HKT tomorrow (8 November 2019, Friday) under the stock code of 1875, with board lot of 400 Shares each.

The final offer price of TOT BIOPHARM was determined at HK$6.55 per Offer Share. The net proceeds to be received by the Company is estimated to be approximately HK$511.4 million from the Global Offering (assuming that the Over-allotment Option is not exercised, after deduction of the underwriting fees and commission and estimated expenses payable by the Company in connection with the Global Offering). The Hong Kong Offer Shares initially offered under the Hong Kong Public Offering have been significantly over-subscribed by approximately 11.95 times of the total number of 9,000,000 Hong Kong Offer Shares initially available for subscription under the Hong Kong Public Offering. The International Offer Shares initially offered under the International Offering have been moderately over-subscribed.

Focusing on Innovative Oncology Drugs and Therapies, Developed Diversified Product Mix

TOT BIOPHARM is a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative oncology drugs and therapies. The Company has a comprehensive portfolio of oncology drug candidates, which include monoclonal antibodies (mAbs), antibody drug conjugates (ADCs), oncolytic virus products and specialty oncology drugs such as liposome drugs, targeting various types of cancers.

The Company focuses on achieving a diverse product mix. The Company’s comprehensive product pipeline consists of seven biological and five chemical drug candidates, 11 of which are in-house developed. Product pipeline covers a wide variety of cancer types and extended applications with sustainable launch schedule. Leveraging commercial-scale manufacturing and proven sales and marketing capabilities of TOT BIOPHARM, the Company is able to shorten time-to-market and time-to-peak sales of the products when approved.

At present, four biological drug candidates of TOT BIOPHARM are in the clinical stage. Moreover, the Company has submitted the ANDA for one chemical drug candidate, which was accepted by the NMPA in July 2019. In addition, two chemical drug candidates of the Company are undergoing CMC or BE study. The Company targets to launch the products from 2020.

Full Industry Value Chain Capabilities, Attractive to Quality Business Partner

Since inception in 2009, the Group has built and established a fully integrated in-house platform of discovery, process development, quality management, pre-clinical and clinical development, as well as commercial-scale manufacturing facilities and proven sales and marketing capabilities, which provides flexibility and scalability for its business to expand along the innovative drug industry value chain. Equipped with full industry value chain capabilities, TOT BIOPHARM adopts an open platform business model under which the Company collaborates with third party business partners at different stages of the industry value chain. Benefiting from the strong platform capabilities, the Company has great support from several reputable investors such as Vivo Capital and Advantech Capital.

Ms. Yeh-Huang Chun-Ying, Executive Director and General Manager of TOT BIOPHARM said, "Since the inception of TOT BIOPHARM, we strive to develop innovative drugs that have high viability for commercialization and clear market demands to reach a wider group and benefit the majority of patients. Currently, our product pipeline consists 12 of biological and chemical drug candidates, of which our core product TAB008 is expect to launch between late 2020 and early 2021. In the future, we target to commercialize these pipeline products in China once approved and plan to establish our presence in the overseas markets in the long term."

One of the First Mover in Bevacizumab Market

The bevacizumab market in China has significant growth potential. The bevacizumab market in China is expected to reach RMB3.2 billion in 2018 and is estimated to grow to RMB13.1 billion in 2023, representing a CAGR of 32.7%, according to Frost & Sullivan.

TAB008, the most advanced biological drug candidate and Core Product of the Company, is currently undergoing Phase III clinical trials in China, and is expected to be launched between the end of 2020 and early 2021, subject to regulatory approval. It is an anti-VEGF mAb and biosimilar drug candidate to bevacizumab, which will be sold under the trade name of Avastin. The Company adopts and develops cost-effective technologies the Company use 2,000L bioreactors to manufacture TAB008, demonstrating the readiness for cost-efficient commercial production. Leveraging commercial-scale manufacturing and proven sales and marketing capabilities of, the Company is able to shorten time-to-market and time-to-peak sales of our TAB008 when approved.

Well-Established and Advanced Technology Platforms and Manufacturing Facilities

The Company owns and operates cost-efficient commercial-scale and state-of-the-art manufacturing facilities, built to and operating at international standards, at Suzhou Production Center, of which the No. 2 campus has a designed capacity of 16,000L to accommodate high-quality commercial manufacturing. At the same time, TOT BIOPHARM has established three advanced technology platforms, including the Therapeutic Monoclonal Antibody and ADC Technology Platform, the Gene Engineering Based Therapeutics Technology Platform and the Innovative Drug Delivery Technology System, to develop different types of oncology drugs. TOT BIOPHARM owns self-developed know-how for manufacturing processes and developed a robust product pipeline, which will continue to further the clinical and pre-clinical development of drug candidates and manage pipeline development to achieve fast-to-market commercialization. Supported by three advanced technology platforms, the Company has gained five invention patents and one utility model patent in China.

Industry-leading Talent Base

TOT BIOPHARM has assembled a senior management team with extensive experience and profound knowledge in cancer treatment. The senior management team of the Company represents a full spectrum of complementary skillsets, including pre-clinical research, clinical development, manufacturing, quality control and assurance and commercialization, and broad experience in different cancer treatments including mAbs, ADCs, oncolytic virus and specialty oncology drugs, which lead the Company to achieve future success. The Company’s research and development staff are also able to progress the development efficiently, keep track of achievements in their respective fields and create innovative solutions.

Ms. Yeh-Huang Chun-Ying concluded, "Looking ahead, TOT BIOPHARM’s mission is to build a leading brand name of oncology treatments trusted by patients and their families as well as medical professionals in China. We believe, by commercializing TAB008, rapidly advancing our clinical trials for drug candidates, enriching product portfolio by focusing on immune-oncology combination therapies, strengthening our in-house sales and marketing force and commercial-scale manufacturing capacities and maximizing the value of our integrated platform, the Group has even brighter prospects."

Accelerate Diagnostics Reports Third Quarter 2019 Financial Results

On November 7, 2019 Accelerate Diagnostics, Inc. (Nasdaq: AXDX) reported financial results for the third quarter ended September 30, 2019 (Press release, ACCELERATED MEDICAL DIAGNOSTICS, NOV 7, 2019, View Source [SID1234550781]).

"Our placement and revenue results for the third quarter came in below our expectations due to an elongated sales cycle and the timing of commercial go-lives during the quarter," said Larry Mehren, president and chief executive officer of Accelerate Diagnostics, Inc. "However, we saw several encouraging signs of improvement during the quarter, including a record number of go-lives in September, an increasingly robust sales funnel and continued progress with our respiratory trial and in China. As momentum in placements and go-lives continues to improve, we remain on pace to achieve the low end of our 300-400 placement target. Looking ahead, we acknowledge the need for greater consistency and predictability in our results, and we are focused on improving our commercial execution under Jack Phillip’s leadership, as we continue our pursuit of bringing Accelerate’s life-saving technology to as many patients as possible worldwide."

Third Quarter 2019 Highlights

Added 37 net new commercially contracted instruments, compared to 29 in the third quarter of 2018.
Net sales of $2.3 million, compared to $1.4 million in the third quarter of 2018. Instrument revenue decreased year-over-year, reflecting the Company’s introduction of a reagent rental business model in September of 2018. Consumable revenue grew by over 175% as compared to the third quarter of 2018 and by approximately 15% over the prior quarter.
Gross margin was 51% for the quarter, compared to 50% in the third quarter of 2018. This small increase was the result of lower consumable production costs per unit as production volumes increase.
Selling, general, and administrative expenses for the quarter were $12.7 million, compared to $12.2 million in the third quarter of 2018. This increase was driven by higher non-cash equity-based compensation expense.
Research and development (R&D) costs for the quarter were $6.1 million, compared to $7.9 million in the third quarter of 2018. This decrease was the result of lower employee non-cash equity-based compensation expense.
Net loss was $20.4 million in the third quarter, or $0.37 per share, which included $3.1 million in non-cash stock-based compensation expense.
Net cash used in the quarter was $15.9 million, and the company ended the quarter with total cash, investments, and cash equivalents of $122.0 million.
Year-to-Date 2019 Highlights

Added 167 net new commercially contracted instruments year to date, compared to 69 for the same period from 2018.
Net sales of $5.8 million, compared to $3.8 million for the same period from 2018. Consumable revenue grew by over 150% through the first three quarters of 2019, compared to the same period in the prior year.
Gross margin was 50%, compared to 51% for the same period from 2018. This small decrease was the result of inventory timing items that did not repeat in the current year. After normalizing for the effect of these pre-FDA instrument inventory previously written off to R&D, gross margin improved by 500 basis points year-to-date due to higher consumable production levels.
Selling, general, and administrative expenses were $38.3 million year to date, compared to $41.8 million for the same period from 2018. This decrease was driven by lower stock-based compensation expense in the current year.
Research and development (R&D) costs were $19.1 million year to date, compared to $20.7 million for the same period from 2018. This decrease was the result of lower employee non-cash equity-based compensation expense.
Net loss was $63.0 million year to date, or $1.16 per share, which included $9.4 million in non-cash stock-based compensation expense.
Net cash used year to date was $44.5 million, and the company ended the quarter with total cash, investments, and cash equivalents of $122.0 million.
Full financial results for the quarter ending September 30, 2019 will be filed on Form 10-Q through the Securities and Exchange Commission’s (SEC) website at View Source

Audio Webcast and Conference Call

The company will host a conference call at 4:30PM ET today to review its first quarter results. To participate in the conference call, dial +1.877.883.0383 and enter the conference ID: 2508360. International participants may dial +1.412.902.6506. Please dial in 10 to 15 minutes prior to the start of the conference call. A replay of the call will be available by telephone at +1.877.344.7529 (U.S.) or +1.412.317.0088 (international) using replay code 10136055 until November 28, 2019.

This conference call will also be webcast and can be accessed from the "Investors" section of the company’s website at axdx.com/investors. A replay of the audio webcast will be available until November 28, 2019.

Navidea Biopharmaceuticals Reports Third Quarter 2019 Financial Results

On November 7, 2019 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the third quarter ended September 30, 2019 (Press release, Navidea Biopharmaceuticals, NOV 7, 2019, View Source [SID1234550637]).

"During the third quarter, Navidea continued to deliver on the Company’s initiatives to complete the NAV 3-31 Phase 2B trial in patients with Rheumatoid Arthritis ("RA")," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "The Company furthered its partnership discussions around the globe, and most importantly, met its internal enrollment goals for the ongoing RA trials. We also achieved several key milestones in Navidea’s clinical pipeline, and continue to advance programs in the therapeutics division. Navidea remains focused on potentially bringing its RA diagnostic to market within the next 18 to 24 months."

Third Quarter 2019 Highlights and Subsequent Events

Continued with double-digit subject enrollment in the Company’s NAV3-31 Phase 2b study in rheumatoid arthritis ("RA").

Announced positive results of the first interim analysis of the NAV3-31 Phase 2b study, demonstrating that Tc99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active RA, and that this imaging is stable, reproducible, and can define joints with and without RA-involved inflammation.

Entered into a collaboration agreement with IMV Inc., a clinical-stage immuno-oncology company, to explore the combinatory effect of Navidea’s and IMV’s proprietary immuno-oncology platforms.

Received the Notice of Award from the National Heart, Lung and Blood Institute for the Small Business Technology Transfer Phase 1 grant application that will support a collaboration with the University of Alabama at Birmingham titled "Gallium 68 Tilmanocept for PET Imaging of Atherosclerosis Plaques", with studies set to begin shortly.

Completed patient enrollment in NAV3-24, the NIH-funded imaging trial in Kaposi Sarcoma patients titled, "An Evaluation of the Safety of Escalating Doses of Tc 99m Tilmanocept by Intravenous (IV) Injection and a Comparison to Subcutaneous (SC) Injection in Human Immunodeficiency Virus (HIV) Subjects Diagnosed with Kaposi Sarcoma (KS)".

Continued enrollment in the Investigator Initiated Phase 2 trial being run at the Massachusetts General Hospital evaluating Tc 99m tilmanocept uptake in atherosclerotic plaques of HIV-infected individuals.

Michael Rosol, Chief Medical Officer for Navidea, said, "The clinical research team has been working diligently to advance the technology in key disease areas, with an emphasis on our ongoing RA trials. We continue to advance our Phase 2B trial in RA, building upon the recently announced interim analysis results, and are planning ahead for the Phase 3 trial."

Financial Results

Navidea’s consolidated balance sheets, statements of operations, and statements of stockholders’ equity have been restated, as required, for all periods presented to reflect the April 2019 reverse stock split as if it had occurred on January 1, 2018. The consolidated statements of cash flows were not impacted by the reverse stock split.

Total revenues for the third quarter of 2019 were $237,000, compared to $231,000 in the same period of 2018. Total revenues for the first nine months of 2019 were $539,000, compared to $1.1 million in the same period of 2018. The year-to-date decrease was primarily due to a decrease in license revenue related to the sublicense of the Company’s NAV4694 technology, which included a non-refundable upfront payment in 2018, coupled with a reduction in grant revenue related to Small Business Innovation Research grants from the National Institutes of Health supporting Manocept development.

Research and development ("R&D") expenses for the third quarter of 2019 were $1.8 million, compared to $1.2 million in the same period of 2018. R&D expenses for the first nine months of 2019 were $3.6 million, compared to $3.4 million in the same period of 2018. The year-to-date increase was primarily due to net increases in drug project expenses, which includes Manocept diagnostic and Tc99m tilmanocept development costs, offset by decreased Manocept therapeutic and NAV4694 development costs. The net increase in R&D expenses also included decreased compensation costs resulting from net decreased salaries and headcount.

Selling, general and administrative ("SG&A") expenses for the third quarter of 2019 were $1.5 million, compared to $2.7 million in the same period of 2018. SG&A expenses for the first nine months of 2019 were $5.1 million, compared to $6.2 million in the same period of 2018. Decreased compensation, primarily related to the resignation of the former CEO in 2018, coupled with net decreased related support costs such as director compensation, general office expenses and taxes, were offset by increased legal and professional services, primarily related to the Goldberg litigation.

Navidea’s net loss attributable to common stockholders for the third quarter of 2019 was $3.1 million, or $0.17 per share, compared to a net loss attributable to common stockholders of $3.8 million, or $0.46 per share, for the same period in 2018. Navidea’s net loss attributable to common stockholders for the first nine months of 2019 was $8.2 million, or $0.62 per share, compared to a net loss attributable to common stockholders of $13.0 million, or $1.58 per share, for the same period in 2018.

Navidea ended the third quarter of 2019 with $2.8 million in cash and investments.

Conference Call Details

Investors and the public are invited to dial into the earnings call through the information listed below, or participate via the audio webcast on the company website. Participants who would like to ask questions during the question and answer session will be prompted by the moderator, who will provide instructions.

Event:

Q3 2019 Earnings and Business Update Conference Call

Date:

Thursday, November 7, 2019

Time:

5:00 p.m. (EST)

U.S. & Canada Dial-in:

877-407-0312

International Dial-in:

+1 201-389-0899

Conference ID:

13696379

Webcast Link: View Source

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

PIERIS PHARMACEUTICALS TO HOST R&D EVENT

On November 7, 2019 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer and other indications, reported that the Company will host an R&D event in New York on Tuesday, November 19, 2019 from 12:00 – 3:30 PM EST (Press release, Pieris Pharmaceuticals, NOV 7, 2019, View Source [SID1234550653]).

The R&D event will feature presentations from management and thought leaders in immuno-oncology and respiratory diseases, including:

Michael A. Curran, PhD, Associate Professor, Department of Immunology and Scientific Director, ORBIT Platform, The UT MD Anderson Cancer Center
Geoffrey Y. Ku, MD, Assistant Attending Physician and Head, Esophagogastric Section, Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering
Anuradha Ray, PhD, Professor of Medicine, Department of Immunology and UPMC Endowed Chair in Lung Immunology Medicine, University of Pittsburgh
Sally E. Wenzel, MD, Professor of Medicine, Department of Medicine; Chair, Department of Occupational & Environmental Health; Acting Director, Asthma Environmental Lung Health Institute and UPMC Endowed Chair of Translational Airway Biology, University of Pittsburgh
Presentations will include expert discussant perspectives on recently presented data for PRS-343 and PRS-060, emerging data from the ongoing PRS-343 combination trial with atezolizumab, and perspectives on how these drug candidates could best fit into the emerging landscapes of asthma and immuno-oncology.

The event will be accessible via a live webcast through this link beginning at 12:30 PM EST on November 19, 2019.

In-person attendance is by invitation only. For more information, please contact [email protected].

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Category: Uncategorized

Cardinal Health Reports First Quarter Results for Fiscal Year 2020

TOT BIOPHARM (1875.HK) Proceeded with IPO raising over HK$500 million

Accelerate Diagnostics Reports Third Quarter 2019 Financial Results

Navidea Biopharmaceuticals Reports Third Quarter 2019 Financial Results

PIERIS PHARMACEUTICALS TO HOST R&D EVENT