On April 14, 2020 Applied BioMath, LLC, the industry leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, reported a collaboration with OncoMyx Therapeutics, a privately-held oncolytic immunotherapy company (Press release, Applied BioMath, APR 14, 2020, View Source [SID1234556322]). Applied BioMath will develop a systems pharmacology model to mechanistically evaluate the pharmacokinetics and pharmacodynamics (PK/PD) of OncoMyx’s oncolytic myxoma virus (MYXV) platform and therapeutic programs. OncoMyx is developing oncolytic immunotherapies based on the MYXV platform to orchestrate an immune response and treat various cancers.

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"In previous roles, I have collaborated with Applied BioMath and believe that their systems pharmacology modeling provides significant value to therapeutic development," said Leslie Sharp, Ph.D., Chief Scientific Officer at OncoMyx. "Incorporating this data into our development activities could help de-risk and accelerate our therapeutic programs in oncolytic immunotherapies for a wide range of cancers."

Applied BioMath employs a rigorous fit-for-purpose model development process which aims to quantitatively integrate knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms. Their approach provides objective insight to support decision-making throughout discovery, development, and into the clinic enabling project teams to utilize experiments and resources more efficiently.

"Two key components of our modeling approach are the focus on mechanism and fit-for-purpose modeling," said John Burke, PhD, Co-founder, President, and CEO of Applied BioMath. "Incorporating the mechanism allows the model to more accurately reflect the biology of the drug-disease system and translate well across species, while the fit-for-purpose aspect enables us to create and analyze the model in a timely manner so teams have the results for consideration in their decisions."

For more information on examples of how Applied BioMath’s modeling approach has helped de-risk and accelerate over 100 projects, please visit www.appliedbiomath.com/case-studies.

On April 14, 2020 Coherus BioSciences, Inc. ("Coherus" or the "Company", Nasdaq: CHRS), reported its intention to offer, subject to market and other conditions, $200,000,000 aggregate principal amount of convertible senior subordinated notes due 2026 (the "notes") in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Coherus Biosciences, APR 14, 2020, View Source [SID1234556290]). Coherus also expects to grant the initial purchasers of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date notes are first issued, up to an additional 30,000,000 principal amount of notes.

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The notes will be general unsecured obligations of Coherus, and will be subordinated to the Coherus’ designated senior indebtedness. The notes will accrue interest payable semi-annually in arrears and will mature on April 15, 2026, unless earlier repurchased or converted. At any time before the close of business on the second scheduled trading day immediately before the maturity date, noteholders may convert their notes at their option into shares of Coherus’ common stock, together, if applicable, with cash in lieu of any fractional share, at the then-applicable conversion rate. The notes will not be redeemable at Coherus’ election before maturity. The interest rate, initial conversion rate and other terms of the notes will be determined at the pricing of the offering.

Coherus intends to use a portion of the net proceeds from the offering to fund the cost of entering into the capped call transactions described below. Coherus intends to use the remainder of the net proceeds from the offering for opportunistic pipeline acquisitions or licenses, working capital, and other general corporate purposes, which may include other debt repayment in the future. Coherus has not entered into any agreements or commitments with respect to any material acquisitions or licenses at this time. If the initial purchasers exercise their option to purchase additional notes, then Coherus intends to use a portion of the additional net proceeds to fund the cost of entering into additional capped call transactions as described below.

In connection with the offering of the notes, Coherus expects to enter into privately negotiated capped call transactions with one or more of the initial purchasers or their respective affiliates and/or other financial institutions (the "option counterparties"). If the initial purchasers exercise their option to purchase additional notes, Coherus expects to enter into additional capped call transactions with the option counterparties.

In connection with establishing their initial hedges of the capped call transactions, the option counterparties or their respective affiliates expect to enter into various derivative transactions with respect to Coherus’ common stock and/or purchase shares of Coherus’ common stock concurrently with or shortly after the pricing of the notes. This activity could increase (or reduce the size of any decrease in) the market price of Coherus’ common stock or the notes at that time.

In addition, the option counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Coherus’ common stock and/or purchasing or selling Coherus’ common stock or other securities of Coherus in secondary market transactions following the pricing of the notes and prior to the maturity of the notes. This activity could also cause or avoid an increase or decrease in the market price of Coherus’ common stock or the notes, which could affect the value of Coherus’ common stock that noteholders will receive upon conversion of the notes.

The offer and sale of the notes and the shares of common stock issuable upon conversion of the notes have not been, and will not be, registered under the Securities Act or any other securities laws, and the notes and such shares cannot be offered or sold except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, the notes or the shares of common stock issuable upon conversion of the notes, nor will there be any sale of the notes or such shares, in any state or other jurisdiction in which such offer, sale or solicitation would be unlawful.

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."