On January 22, 2020 Johnson & Johnson (NYSE: JNJ) reported results for fourth-quarter and full year 2019 (Press release, Johnson & Johnson, JAN 22, 2020, View Source [SID1234553410]). "We delivered strong underlying sales and earnings growth in 2019, driven by the strength of our Pharmaceutical business, accelerating performance in our Medical Devices business and improved profitability in our Consumer business," said Alex Gorsky, Chairman and Chief Executive Officer. "As we enter into 2020 and this next decade, our strategic investments focused on advancing our pipelines and driving innovation across our entire product portfolio, position us well to deliver long-term sustainable growth and value to our shareholders."

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Mr. Gorsky continued, "I am extremely proud of our talented and dedicated colleagues who live Our Credo values each and every day, and are inspired to deliver transformative healthcare solutions that improve the lives of our patients and consumers around the world."
OVERALL FINANCIAL RESULTS:
q4chart1.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:

q4chart2.jpg

q4chart3.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 SALES RESULTS:

q4chart4.jpg

q4chart5.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

FULL-YEAR 2019 SEGMENT COMMENTARY:

Consumer
Consumer worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 1.4%* driven by NEUTROGENA beauty products and over-the-counter products including TYLENOL and MOTRIN analgesics, partially offset by lower sales of baby care products.

Pharmaceutical
Pharmaceutical worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 5.8%* 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, TREMFYA (guselkumab), a biologic for the treatment of adults living with moderate to severe plaque psoriasis, INVEGA SUSTENNA/XEPLION/INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults, and ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer. This growth was partially offset by biosimilar and generic competition, primarily declines in REMICADE (infliximab), a biologic approved for the treatment of a number of immune-mediated inflammatory diseases, U.S. ZYTIGA (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic, castration-resistant prostate cancer and international VELCADE (bortezomib), a proteasome inhibitor for the treatment of multiple myeloma.

Medical Devices
Medical Devices worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 3.9%* driven by electrophysiology products in the Interventional Solutions business, international energy and endocutter products in the Advanced Surgery business, and ACUVUE contact lenses in the Vision business.

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

DARZALEX (daratumumab) – European Commission Approves Combination with Bortezomib, Thalidomide and Dexamethasone for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible1
(press release)
SPRAVATO (esketamine) Nasal Spray – Approved in Europe for Adults with Treatment-Resistant Major Depressive Disorder
(press release)
DARZALEX (daratumumab) – European Commission Approves Combination with Lenalidomide and Dexamethasone for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible
(press release)
STELARA (ustekinumab) – U.S. FDA Approval for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis
(press release)
Regulatory
Submissions
SPRAVATO (esketamine) – Submission of a Type II Variation Application to the European Medicines Agency (EMA) Seeking Expanded Use as a Treatment for Depressive Symptoms in Adults with Major Depressive Disorder Who Have Current Suicidal Ideation with Intent1
(press release)
IMBRUVICA (ibrutinib) – Supplemental NDA Submitted to U.S. FDA and Type II Variation Submitted to EMA1 Seeking Approval of Combination with Rituximab for Previously Untreated Patients with CLL
(press release)
(press release)
Ebola Vaccine Regimen – Submission of MAA to EMA for Prevention of Ebola Virus Disease (EVD) caused by Zaire Ebolavirus Species.
(press release)
TREMFYA (guselkumab) – Submission of a Type II Variation Application to the EMA Seeking to Expand Use in the Treatment of Adults with Active Psoriatic Arthritis
(press release)
Other
Completion of Acquisition of Bermekimab, an investigational compound for multiple dermatological indications, from XBiotech Inc. 1
(press release)
Rilpivirine and Cabotegravir – U.S. FDA issues Complete Response Letter Issued for Investigational Two-Drug Long-Acting HIV Regimen
(press release)
Completion of Acquisition of TARIS Biomedical with Focus on Transforming the Treatment of Bladder Cancer
(press release)
Agreement Announced to Acquire Remaining Stake in Verb Surgical Inc.
(press release)
BCMA CAR-T Therapy Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of Relapsed or Refractory Multiple Myeloma
(press release)
J&J Vision Introduces TECNIS Toric II 1-Piece IOL as New Monofocal Option for Cataract Patients with Astigmatism
(press release)
Ethicon Launches VISTASEAL Fibrin Sealant (Human) To Manage Bleeding During Surgery
(press release)
New Cervical Spine System from DePuy Synthes Advances Treatment Options for Patients with Complex Cervical Spine Disorders
(press release)
1 Subsequent to the quarter

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.

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: 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 8:00 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 January 22, 2020 Aethlon Medical, Inc. (Nasdaq:AEMD) ("Aethlon" or the "Company"), a medical device technology company focused on developing products to diagnose and treat life and organ threatening diseases, reported the completion of its previously announced registered direct offering of 1,885,378 shares of its common stock, at a purchase price per share of $2.00, priced at-the-market under Nasdaq rules (Press release, Aethlon Medical, JAN 22, 2020, View Source [SID1234553425]). Additionally, Aethlon issued to the purchasers unregistered warrants to purchase up to 942,689 shares of common stock. The warrants have an exercise price of $2.75 per share of common stock, are exercisable immediately and will expire five and one-half years from the issuance date.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds to Aethlon, before deducting placement agent fees and other offering expenses, are approximately $3.77 million.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) were offered by Aethlon pursuant to a "shelf" registration statement on Form S-3 that was originally filed on May 10, 2019 and declared effective by the Securities and Exchange Commission ("SEC") on August 1, 2019 and the base prospectus contained therein (File No. 333-231397). The offering of the shares of common stock was made by means of a prospectus supplement that forms part of the registration statement. A final prospectus supplement and accompanying base prospectus relating to the shares of common stock being offered were filed with the SEC. Electronic copies of the final prospectus supplement and accompanying base prospectus may be obtained on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at 646-975-6996 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On January 22, 2020 Neurotrope, Inc. (the "Company") (NASDAQ:NTRP) reported that it has received commitments from institutional investors and pre-existing high net worth individuals to purchase an aggregate of $18 million of the Company’s securities in a registered direct offering (Press release, Neurotrope, JAN 22, 2020, View Source [SID1234553906]).

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The Company entered into definitive purchase agreements with these investors pursuant to which the Company agreed to sell an aggregate of 18,000 shares of its Series D Convertible Preferred Stock (which are convertible into a total of approximately 10,909,091 shares of common stock) and warrants potentially exercisable for up to approximately 10,909,091 additional shares of its common stock. Subject to certain ownership limitations, the preferred stock is convertible at any time at the option of the holder into shares of common stock at a conversion price of $1.65 (which represents $0.20 above $1.45, the closing price of the common stock on the previous trading day). The warrants will be exercisable at a price of $1.65 per share and will expire five years from the issuance date. The closing of the offering is expected to take place on or about January 23, 2020, subject to the satisfaction of customary closing conditions.

The estimated net proceeds to the Company from the offering are expected to be approximately $16.4 million. The Company intends to use the net proceeds from this offering for general corporate purposes.

Katalyst Securities LLC acted as our Financial Advisor on this transaction.

A shelf registration statement (File No. 333-217089) relating to the shares of preferred stock and warrants issued in the offering (and the shares of common stock issuable upon conversion of the preferred stock exercise of the warrants) has been filed with and declared effective by the Securities and Exchange Commission (the "SEC"). A prospectus supplement relating to the offering will be filed by the Company with the SEC. Copies of the prospectus supplement, together with the accompanying prospectus, can be obtained at the SEC’s website at View Source, from Katalyst Securities LLC by e-mailing [email protected], or from Neurotrope, Inc., 1185 Avenue of the Americas, 3rd Floor, New York, New York 10036, Attention: Investor Relations.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities of the Company in this offering. There shall not be any offer, solicitation of an offer to buy, or sale of securities in any state or jurisdiction in which such an offering, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offering will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

On January 22, 2020 Tetraphase Pharmaceuticals, Inc. (Nasdaq: TTPH), a biopharmaceutical company focused on commercializing its novel tetracycline XERAVATM (eravacycline for injection) to treat serious and life-threatening infections, reported that it has entered into a definitive agreement with Armistice Capital, LLC, a healthcare-focused institutional investor, for the purchase, in a private placement priced at-the-market under Nasdaq rules, of (i) 1,270,000 shares of common stock and accompanying warrants to purchase an aggregate of 1,270,000 shares of common stock, and (ii) pre-funded warrants to purchase up to an aggregate of 2,063,334 shares of common stock and accompanying warrants to purchase up to an aggregate of 2,063,334 shares of common stock (Press release, Tetraphase, JAN 22, 2020, View Source [SID1234553411]). Each share of common stock and accompanying common stock warrant are being sold together at a combined price of $3.00, and each pre-funded warrant and accompanying common stock warrant are being sold together at a combined price of $2.999, for gross proceeds of approximately $10 million. Each pre-funded warrant will have an exercise price of $0.001 per share, will be exercisable immediately and will be exercisable until all of the pre-funded warrants are exercised in full. Each common stock warrant will have an exercise price of $2.87 per share, will be exercisable immediately and will expire five years from the date of issuance.

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In addition, the Company has entered into a definitive agreement with certain healthcare-focused institutional investors for the purchase, in a registered direct offering priced at-the-market under Nasdaq rules, of (i) 2,380,105 shares of common stock and accompanying warrants to purchase up to an aggregate of 2,380,105 shares of common stock, and (ii) pre-funded warrants to purchase up to an aggregate of 120,000 shares of common stock and accompanying warrants to purchase up to an aggregate of 120,000 shares of common stock. Each share of common stock and accompanying common stock warrant are being sold together at a combined price of $3.00, and each pre-funded warrant and accompanying common stock warrant are being sold together at a combined price of $2.999, for gross proceeds of approximately $7.5 million. Each pre-funded warrant will have an exercise price of $0.001 per share, will be exercisable immediately and will be exercisable until all of the pre-funded warrants are exercised in full. Each common stock warrant will have an exercise price of $2.87 per share, will be exercisable immediately and will expire five years from the date of issuance.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the private placement and the registered direct offering.

The gross proceeds to the Company from the registered direct offering and the concurrent private placement, before deducting the placement agent’s fees and other estimated offering expenses payable by the Company, will be approximately $17.5 million. The Company intends to use the net proceeds from the registered direct offering and concurrent private placement for the commercialization of XERAVA as well as for working capital and other general corporate purposes. The registered direct offering and concurrent private placement are expected to close on or about January 24, 2020, subject to the satisfaction of customary closing conditions. The closing of the registered direct offering is also conditioned upon the closing of the concurrent private placement.

A shelf registration statement relating to the securities offered in the registered direct offering described above was filed with the Securities and Exchange Commission (the "SEC") on January 25, 2018 and declared effective by the SEC on February 5, 2018. The offering will be made only by means of the written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement, final prospectus supplement and the accompanying prospectus related to the offering will be filed with the SEC and may be obtained, when available, for free by visiting EDGAR on the SEC website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected].

The securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws, and accordingly may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Tetraphase has agreed to file a registration statement with the SEC registering the resale of the shares of common stock issued in the private placement and the shares of common stock issuable upon the exercise of the warrants issued in the private placement (the "Private Placement Securities").

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. Any offering of the Private Placement Securities under the resale registration statement will only be by means of a prospectus.

On January 22, 2020 CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), reported that the company’s Board of Directors has promoted Burke T. Barrett to the position of Chief Executive Officer (CEO), effective January 19, 2020 (Press release, CardioFocus, JAN 22, 2020, View Source [SID1234553426]). Mr. Barrett previously served as CardioFocus’ President and Chief Operating Officer (COO).

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"The Board of Directors are proud to announce Burke’s promotion to CEO," said Paul LaViolette, Executive Chairman of CardioFocus. "From the outset, Burke has played an integral role in the development of the HeartLight platform as well as CardioFocus as a company. He is intimately familiar with our technology, employees, investors, customers, regulators, vendors and distributors, and is the perfect person to lead the company as we introduce the breakthrough HeartLight X3 System to the global AFib market."

"I am as excited as ever about the future of CardioFocus given the impressive clinical and commercial results coming out of Europe with our HeartLight X3 System," said Mr. Barrett. "We are pleased to showcase the System at the 25th Annual International AF Symposium being held in Washington D.C. this week and plan to provide an update about the regulatory path and timeline for introduction of the System into the U.S. market in the coming weeks."

Mr. Barrett has over 30 years of experience in the medical device industry. He joined CardioFocus in 2002, and during his more than 15 years with the company has held roles of increasing responsibility from Vice President through to President and COO. Prior to joining CardioFocus, Mr. Barrett was Vice President of Clinical Operations at Cyberkinetics Neurotechnology Systems, Inc., a public medical device company that achieved first-in-man success in novel, implantable brain-computer interfaces. He also served at Cyberonics as the Vice President, Business and Technology Development. Previously, Mr. Barrett held positions in business development, clinical & regulatory affairs, and quality auditing at Biofield Corporation, Dornier Medical Systems, and Bausch & Lomb. Mr. Barrett is a co-inventor on numerous issued and pending patent applications. From 2010-2013 he served as the industry representative on the Food and Drug Administration’s (FDA) Circulatory Systems Device Advisory Panel. He received bachelor’s degrees in chemical engineering and chemistry from Syracuse University and a Master of Business Administration from Kennesaw University in Atlanta.