On April 14, 2020 Johnson & Johnson (NYSE: JNJ) reported results for first-quarter 2020 (Press release, Johnson & Johnson, APR 14, 2020, View Source [SID1234556307]). The Company also announced earlier today that its Board of Directors declared a 6.3% increase in the quarterly dividend rate, from $0.95 per share to $1.01 per share . At the new rate, the indicated dividend on an annual basis is $4.04 per share compared to the previous rate of $3.80 per share.

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"With Johnson & Johnson’s century-plus history of leading in times of great challenge, we are mobilizing our resources across the Company in the fight against the COVID-19 pandemic," said Alex Gorsky, Chairman and Chief Executive Officer. "Johnson & Johnson is built for times like this, and we are leveraging our scientific expertise, operational scale and financial strength in the effort to advance the work on our lead COVID-19 vaccine candidate. We are committed to beginning production at risk imminently and bringing an affordable and accessible vaccine to the public on a not-for-profit basis for emergency pandemic use."

Mr. Gorsky continued, "I am both proud and amazed at the level of dedication that I have witnessed from our more than 132,000 employees as we have focused on delivering on our commitments and responsibilities to the patients and consumers we serve. Our strong performance in the first quarter reflects the efforts of our teams around the world and the sustainability of our business model. Today, our Board of Directors approved an increase in our quarterly dividend for the 58th consecutive year, underscoring our commitment to delivering value for our shareholders and the confidence we have in our business now and in the future."

OVERALL FINANCIAL RESULTS:
q1chart1.jpg
1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
4 Excludes intangible amortization expense and special items

REGIONAL SALES RESULTS:

regionalsales005.jpg

Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded

SEGMENT SALES RESULTS:

a2020q1segments.jpg
1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded

SEGMENT COMMENTARY:

Consumer Health
Consumer Health worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 11.0%* driven primarily by over-the-counter products including TYLENOL and MOTRIN analgesics; upper respiratory products including ZYRTEC; digestive health products and ZARBEE’S NATURALS. Other contributors to growth were LISTERINE mouthwash in oral care products; NEUTROGENA and AVEENO in skin health/beauty products, as well as STAYFREE and o.b. in international women’s health. Consumer Health results across the majority of franchises were positively impacted by the increased demand related to the COVID-19 pandemic.

Pharmaceutical
Pharmaceutical worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 10.2%* driven by STELARA (ustekinumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, DARZALEX (daratumumab), for the treatment of multiple myeloma, IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer, INVEGA SUSTENNA/XEPLION/INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults, ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer, OPSUMIT (macitentan), an oral endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension to delay disease progression, TREMFYA (guselkumab), a biologic for the treatment of adults living with moderate to severe plaque psoriasis, and PREZISTA/PREZCOBIX/REZOLSTA/SYMTUZA for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. This growth was partially offset by biosimilar and generic competition, with declines primarily in international VELCADE (bortezomib), a proteasome inhibitor for the treatment of multiple myeloma, REMICADE (infliximab), a biologic approved for the treatment of a number of immune-mediated inflammatory diseases, and PROCRIT (epoetin alfa), a treatment for chemotherapy-induced anemia and patients with chronic kidney disease.

Medical Devices
Medical Devices worldwide operational sales, excluding the net impact of acquisitions and divestitures, declined by 4.8%* driven by the estimated net negative impact of the COVID-19 pandemic and the associated deferral of medical procedures to our Surgery, Orthopaedics, Interventional Solutions and Vision businesses.

NOTABLE NEW ANNOUNCEMENTS IN THE QUARTER:
The information contained in this section should be read in conjunction with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases available online in the Investors section of the Company’s website at news releases.
Regulatory
Approvals

ERLEADA (apalutamide) – European Commission (EC) Approves Expanded Use for Treatment of Patients with Metastatic Hormone-Sensitive Prostate Cancer
(press release)
STELARA (ustekinumab) – EC Approves Expanded Use for Treatment of Pediatric Patients With Moderate To Severe Plaque Psoriasis

(press release)
Regulatory
Submissions
Ponesimod – Submission of New Drug Applications to the U.S. Food and Drug Administration (FDA) and European Marketing Authorization for Treatment of Adults with Relapsing Multiple Sclerosis

(press release)
DARZALEX (daratumumab) – Submission to U.S. FDA for Combination with carfilzomib and dexamethasone (DKd) For Patients with Relapsed/Refractory Multiple Myeloma

Other
Lead Vaccine Candidate for COVID-19; Landmark New Partnership with U.S. Department of Health & Human Services; and Commitment to Supply One Billion Vaccines Worldwide for Emergency Pandemic Use; Announced

(press release)
XARELTO (rivaroxaban) -Landmark Phase 3 VOYAGER PAD Study of XARELTO Plus Aspirin Shows Significant Benefit in Patients with Symptomatic Peripheral Artery Disease (PAD) after Lower-Extremity Revascularization
(press release)
Rilpivirine And Cabotegravir Results of Phase 3 FLARE Study Demonstrate the Safety and Efficacy of Long-Acting Injectable HIV Treatment Regimen through 96 Weeks
(press release)
Rilpivirine and Cabotegravir 48-week Results of Phase 3b ATLAS-2M Study Demonstrate the Safety and Efficacy of Long-Acting Injectable HIV Treatment Administered Every Two Months
(press release)
JNJ-6372 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of Non-Small Cell Lung Cancer
(press release)
RPGR Gene Therapy Granted European Medicines Agency PRIME and Advanced Therapy Medicinal Product Designations for X-Linked Retinitis Pigmentosa
(press release)
HEARTLINE launched, the First-of-its-Kind, Virtual Study Designed to Explore if a New iPhone App and Apple Watch Can Help Reduce the Risk of Stroke1

(press release)
1 iPhone and Apple Watch are trademarks of their respective owners

FULL-YEAR 2020 GUIDANCE:

Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the Company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.
The impact of COVID-19, inclusive of the related investments the Company is making to combat the pandemic, is included in the guidance below.

1 Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures
2 Non-GAAP financial measure; excludes the impact of translational currency
3 Calculated using Euro Average Rate: April 2020 = $1.09 Euro Average Rate: January 2020 = $1.11 (Illustrative purposes only)
4 Non-GAAP financial measure; excludes intangible amortization expense and special items

Other modeling considerations will be provided on the webcast.

WEBCAST INFORMATION:
Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investors section of the Company’s website at events-and-presentations.

On April 14, 2020 China Pharma Holdings, Inc. (NYSE American: CPHI) ("China Pharma," the "Company" or "We"), an NYSE American-listed corporation with a fully-integrated specialty pharmaceuticals subsidiary based in China, reported that it is re-issuing its previous release that was made on March 31, 2020 to incorporate certain disclosures that are required under the NYSE American Company Guide Sections 401(h) and 610(b) (Press release, North China Pharmaceutical, APR 14, 2020, View Source;china-pharma-holdings-inc-reports-fiscal-year-2019-financial-results-301039882.html [SID1234556323]). Included below are these additional disclosures along with the previously disclosed financial results for the fiscal year ended December 31, 2019.

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Full Year Highlights

Revenue decreased 11.4% to $11.0 million in fiscal year 2019 from $12.3 million in fiscal year 2018;
Gross margin was 13.6% in fiscal year 2019, compared to 16.0% in fiscal year 2018.
Impairment loss was $17.0 million in fiscal year 2019 compared to $6.5 million in fiscal year 2018, which represented an increase of $10.5 million;
Loss from operations was $20.4 million in fiscal year 2019 compared to $10.4 million in fiscal year 2018, which represented an increase of $10.0 million;
Net loss was $20.7 million in fiscal year 2019 compared to $10.8 million in fiscal year 2018. Loss per common share was $0.48 per basic and diluted share in fiscal year 2019 compared with $0.25 per basic and diluted share in fiscal year 2018.
Ms. Zhilin Li, China Pharma’s Chairman and CEO, commented, "In 2019, we were continuously influenced by the policies and market environment of the pharmaceutical industry in China. In particular, the various cost control related policies in connection with the healthcare insurance, Group Purchasing Organization ("GPO", a new drug purchasing practice in which the anticipated purchase volume will be announced in the tender announcement, and the suppliers will need to consider their manufacturing capacity in addition to the price) activities, consistency evaluation, and control of the percentage of drug expenditure among the total hospital expenditure. After evaluating the detailed rules of those major policies and considering the potential return of investment and our recent cash flow position, we have made the decision to impair all advances for our remaining four pipeline products in 2019. However, we may resume the development of these formulas in the future if sufficient funding and other favorable conditions arise." Ms. Li continued, "Nevertheless, we continue to explore in the field of comprehensive healthcare. Comprehensive healthcare focuses on people’s daily life, aging and disease and pays attention to all kinds of risk factors and misunderstandings affecting health. We launched a wash-free sanitizer in early 2020 to address the market needs caused by COVID-19 in China. We aim to leverage our expertise in the PRC for the development, manufacture and commercialization of pharmaceutical and comprehensive healthcare products for the benefit of human health."

Full Year Results

Revenue decreased by 11.4% to $11.0 million for the year ended December 31, 2019, as compared to $12.3 million for the year ended December 31, 2018. This decrease in sales revenue was mainly due to the increased standards of drug tender procurement of GPO (drugs have to pass the consistency evaluation in order to participate in the GPO), and the decreased "drug ratio"(the ratio of drug expenditure to patients’ total hospital expenditure) from 60% a few years ago to approximately 30% in 2019, which were promoted by the healthcare insurance cost control policy.

Gross profit for the year ended December 31, 2019 was $1.5 million, compared to $2.0 million in 2018. Our gross profit margin in 2019 was 13.6% compared to 16.0% in 2018. This decline in our gross profit margin was mainly due to a decrease in our sales but our fixed costs remained the same.

Our selling expenses for the year ended December 31, 2019 were $2.4 million, a decrease of $0.9 million compared to $3.2 million for the year ended December 31, 2018. Selling expenses accounted for 21.5% of the total revenue in 2019 compared to 26.1% in 2018.

Our general and administrative expenses for the year ended December 31, 2019 were $2.3 million, as compared to $1.9 million in 2018. General and administrative expenses accounted for 21.0% and 15.8% of our total revenues in 2019 and 2018, respectively.

Our bad debt expenses for the year ended December 31, 2019 was $0.003 million, which represented a decrease of $0.601 million compared to $0.604 million in 2018. The decrease in our bad debt expenses was mainly due to the Company’s adjustment of its credit policies to customers and the request of more advanced payment from customers prior to the shipping of products for the year ended December 31, 2019 compared to December 31, 2018.

We recognized $17.02 million impairment loss for the year ended December 31, 2019, compared to $6.48 million in 2018, among which, there was an impairment loss for the advances made to laboratories for the years ended December 31, 2019 and 2018 in the amount of $17,015,117 and $6,134,271, respectively. As a pharmaceutical company, we have been focusing on the development and maintenance of our intangible assets, mainly in the form of medical formulas. The consistency evaluation is expected to have a significant impact on all generic products not only in our pipeline, but also throughout the existing Chinese market. After evaluating the detailed rules under this policy and considering the return of investment and our recent cash flow position, our management made certain assessments regarding the impairment of our intangible assets, and identified four and two formulas that were unlikely to generate positive cash flow in the foreseeable future and therefore recognized impairment loss on them accordingly as of December 31, 2019 and December 31, 2018, respectively. The management determined to impair all advances at December 31, 2019, but may resume the development of these formulas in the future if sufficient funding and other favorable conditions arise.

Net loss for year ended December 31, 2019 was $20.7 million, or $0.48 each basic and diluted share, compared to net loss of $10.8 million, or net loss of $0.25 each basic and diluted share, for the year ended December 31, 2018. The increase in net loss was mainly a result of the decrease in impairment of long term assets.

Financial Condition

As of December 31, 2019 the Company had cash and cash equivalents of $1.1 million compared to $1.2 million as of December 31, 2018. Consider using "Working capital deficit increased to $4.5 million as of December 31, 2019 from $1.3 million as of December 31, 2018.

As of December 31, 2019, our net accounts receivable was $0.6 million, compared to $0.9 million as of December 31, 2018.

For the year ended December 31, 2019, cash flow from operating activities was $0.6 million, as compared to $1.9 million in 2018.

Receipt of Audit Opinion with Going Concern Explanatory Paragraph

The audit opinion provided by the Company’s independent registered public accounting firm relating to the Company’s audited consolidated financial statements (the "financial statements") for the year ended December 31, 2019 included a going concern explanatory paragraph. The financial statements were included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, which was filed with the Securities and Exchange Commission on March 30, 2020. The explanatory paragraph in the opinion of the Company’s independent registered public accounting firm notes that as discussed in Note 1 to the financial statements, the Company incurred recurring losses from operations, has net current liabilities and an accumulated deficit that raise substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1 to the financial statements and the financial statements do not include any adjustments that might result from the outcome of this uncertainty.

On April 14, 2020 Propanc Biopharma, Inc. (OTC:PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing new cancer treatments for patients suffering from recurring and metastatic cancer, reported that the first allowance for an important patent family was received from the Australian Patent Office (Press release, Propanc, APR 14, 2020, View Source [SID1234556308]). The allowed claims capture different dosage regimens, including those to be the focus of ongoing research, as the Company’s lead product candidate, PRP, advances towards clinical trials for the treatment of patients with advanced solid tumors.

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The key patent application, citing proenzyme compositions, is one of four patent families, consisting of 65 patents either in force or pending, and is the first to be allowed covering high doses of two proenzymes trypsinogen and chymotrypsinogen for the treatment of cancer. As a result, examination of patent applications in a number of other jurisdictions can be expedited where the Australian claims will be utilized for supplementary examination.

"The approval of this key patent application in Australia is a significant step forward for our intellectual property portfolio and is especially important as we prepare for entering the clinic in Australia," said James Nathanielsz, Propanc’s Chief Executive Officer.

Dr Julian Kenyon, Propanc’s Chief Scientific Officer said, "The aim of our first clinical trial will be to identify the maximum tolerated dose patients with advanced solid tumors, knowing that we continue to expand our intellectual property portfolio as a world first in the cancer field using a novel proenzyme treatment approach, helps build confidence that we are on track with our research."

On April 14, 2020 IDEXX Laboratories, Inc. (NASDAQ: IDXX), a global leader in veterinary diagnostics, veterinary practice software and water microbiology testing, reported that it has scheduled the release of its 2020 first quarter financial results for Thursday, April 30, 2020 before the market opens (Press release, IDEXX Laboratories, APR 14, 2020, View Source [SID1234556324]). The Company will host a conference call beginning at 8:30 a.m. ET on that day.

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Individuals can access a live webcast of the conference call through a link on the IDEXX website, www.idexx.com/investors. An archived edition of the webcast will be available after 1:00 p.m. ET on that day via the same link and will remain available for one year.

The live call also will be accessible by telephone. To listen to the live conference call, please dial 1-877-336-4441 or 1-409-207-6985 and reference access code 1103408.

On April 14, 2020 MEI Pharma, Inc. (NASDAQ: MEIP) and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151) reported that the companies have entered into a global license, development and commercialization agreement to further develop and commercialize MEI’s ME-401, an oral, once-daily, investigational drug-candidate, selective for phosphatidylinositol 3-kinase delta (PI3Kδ), in clinical development for the treatment of B-cell malignancies (Press release, MEI Pharma, APR 14, 2020, View Source [SID1234556292]). MEI and Kyowa Kirin will co-develop and co-promote ME-401 in the U.S., with MEI booking all revenue from U.S. sales. Kyowa Kirin has exclusive commercialization rights outside of the U.S.

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ME-401 is being studied in the ongoing Phase 2 TIDAL clinical trial evaluating patients with relapsed or refractory follicular lymphoma which, subject to results, may support an accelerated approval of a marketing application with the U.S. Food and Drug Administration (FDA). An ongoing Phase 1b study is evaluating ME-401 as a monotherapy and in combination with rituximab (Rituxan) or zanubrutinib (Brukinsa) in patients with B-cell malignancies. Also, a Phase 1 study was initiated in 2019 evaluating ME-401 as a monotherapy in patients with indolent B-cell malignancy in Japan.

"This global partnership with Kyowa Kirin is a key step to achieving our goal of broadly developing and commercializing ME-401, optimizing the opportunity to benefit patients across multiple B-cell malignancies inside and outside the U.S., and also building value for our shareholders," said David M. Urso, J.D., chief operating officer & general counsel of MEI Pharma. "The decision to expand our alliance with Kyowa Kirin is based on the successful relationship we’ve built working together to date under our 2018 Japan license agreement, and the respect we have for Kyowa Kirin and their ability to jointly execute our shared vision of ME-401 in the U.S. and around the world."

"I am delighted to expand our agreement with MEI Pharma for the development and commercialization of ME-401 all over the world," said Tomohiro Sudo, Executive Officer, Director of Strategic Product Planning Department for Kyowa Kirin. "We believe that ME-401 may be an important new treatment option for patients and further enhances our global oncology pipeline."

About the Global License, Development and Commercialization Agreement

Under the terms of the agreement, which substantially retains and consolidates the terms of the 2018 license agreement between MEI and Kyowa Kirin to develop and commercialize ME-401 in Japan, MEI will receive a $100 million upfront payment from Kyowa Kirin. MEI is also eligible to receive up to $582.5 million in additional payments from Kyowa Kirin depending on the achievement of certain U.S. and ex-U.S. development, regulatory and commercial milestones.

If approved by FDA in the U.S., MEI and Kyowa Kirin will co-promote ME-401, with MEI booking all revenue from sales. MEI and Kyowa Kirin will share U.S. profits and costs (including development costs) on a 50-50 basis.

Outside the U.S., Kyowa Kirin will have exclusive commercialization rights, lead commercialization and book all revenues from sales of ME-401. Kyowa Kirin will pay MEI escalating tiered royalties on ex-U.S. sales starting in the teens. Kyowa Kirin will be responsible for all incremental ex-U.S. clinical development costs and all ex-U.S. regulatory, CMC and commercial costs.

The companies have agreed to a development plan designed to broadly evaluate ME-401 in patients with various B-cell malignancies, including in combination with other agents.

Conference Call & Webcast Information (Conducted by MEI)
When: April 14, 2020, 8:00 a.m. ET
Dial-in: 1-877-879-1183 (International Toll: 1-412-902-6703)
Conference ID: 0809665

Please join the conference call at least 10 minutes early to register. You can access the live webcast under the investor relations section of MEI’s website at: www.meipharma.com. A replay of the conference call will be archived under events and webcasts for at least 30 days after the call.

About ME-401

MEI-401 is an investigational treatment and not approved by the U.S. Food and Drug Administration (FDA) or other Health Authorities. Clinical development of ME-401 as an oral, once-daily, selective PI3Kδ inhibitor for the treatment of B-cell malignancies is ongoing. The U.S. FDA recently granted ME-401 Fast Track designation.

MEI is currently conducting two ongoing studies evaluating ME-401. The first is a Phase 2 clinical trial evaluating ME-401 as a monotherapy for the treatment of adults with relapsed or refractory follicular lymphoma after failure of at least two prior systemic therapies including chemotherapy and an anti-CD20 antibody. Subject to the results, upon completion of the Phase 2 clinical trial, ME-401 is planned to be submitted with the FDA to support an accelerated approval of a marketing application under 21 CFR Part 314.500, Subpart H. The second study is a multi-arm, open-label, Phase 1b dose escalation and expansion trial evaluating ME-401 as a monotherapy and in combination with other therapies or investigational agents in patients with relapsed or refractory B-cell malignancies. Additionally, a Phase 1 study was initiated by Kyowa Kirin in 2019 evaluating ME-401 as a monotherapy in patients with indolent B-cell malignancy in Japan.