On March 7, 2019 BioTime, Inc. (NYSE American and TASE: BTX), a clinical-stage biotechnology company focused on degenerative diseases, reported that it will report its fourth quarter and full year 2018 financial and operating results on Thursday, March 14th, 2019, following the close of the U.S. financial markets (Press release, BioTime, MAR 7, 2019, View Source;p=RssLanding&cat=news&id=2390475 [SID1234534111]). BioTime management will also host a conference call and webcast on Thursday, March 14th, 2019, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its fourth quarter and full year 2018 financial results and to provide a business update.

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Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and should request the "BioTime Inc. Call". A live webcast of the conference call will be available online in the Investors section of BioTime’s website. A replay of the webcast will be available on BioTime’s website for 30 days and a telephone replay will be available through March 21st, 2019, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and entering conference ID number 1091719.

On March 7, 2019 Arbutus Biopharma Corporation (Nasdaq: ABUS), an industry-leading Hepatitis B Virus (HBV) therapeutic solutions company, reported its fourth quarter and year-end 2018 financial results and provides a description of recent clinical accomplishments and key 2019 corporate objectives (Press release, Arbutus Biopharma, MAR 7, 2019, View Source [SID1234534131]).

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"Arbutus is committed to developing a cure for chronic Hepatitis B which we maintain can be best achieved by employing a combination of therapeutic agents with distinct, yet complementary mechanisms of action," said Dr. Mark J. Murray, President and Chief Executive Officer of Arbutus. "With multiple clinical trial initiations and data readouts expected throughout the year, 2019 promises to be an eventful and important year for Arbutus as we make progress toward our first novel combination regimen."

Recent Clinical Accomplishments and Key 2019 Objectives

AB-506

In a Phase 1a/1b clinical trial, AB-506, Arbutus’ oral capsid inhibitor, successfully progressed through the healthy volunteer portion and is now being evaluated in HBV patients in the 28-day multiple dose Phase 1b portion of the trial. Top-line results of this Phase 1a/1b clinical trial are expected late in the second quarter of 2019.

A Phase 2 dose-finding and long-term safety trial of AB-506 in combination with an approved nucleoside analogue (NA) is expected to be initiated late in the second half of the year to support AB-506 use in future combination trials.

AB-506 inhibits HBV capsid assembly which inhibits HBV replication, a mode of action complementary to NAs; its use in patients is expected to reduce the levels of HBV DNA in the blood.
AB-729

AB-729 is currently completing IND-enabling studies and is expected to begin a Phase 1a/1b clinical trial in the second quarter of 2019 and progress into HBV patients in the second half of the year. AB-729 is an RNAi agent which blocks HBsAg expression and can be administered subcutaneously and we anticipate will be dosed monthly.

A Phase 2 clinical trial combining AB-729, AB-506 and an approved NA is expected to initiate in the first half of 2020.
AB-452 and RNA Destabilizer Program

Arbutus is developing oral RNA-destabilizers that have shown compelling anti-viral effects in multiple preclinical models. As a result of a nonclinical safety finding with our lead RNA-destabilizer, AB-452, we are conducting a series of in vitro and in vivo studies to further characterize the compound, its mechanism of action and pharmacokinetic profile before deciding to initiate clinical trials. A go/no go decision is expected in the second half of the 2019.

In parallel, the Company is also advancing a number of follow on compounds with distinct chemical scaffolds into the lead optimization stage.
Dr. Michael J. Sofia, Arbutus’ Chief Scientific Officer, stated, "We believe our RNA destabilizer program is amongst the most advanced programs of its kind in the HBV space and we remain confident that this mechanism represents a very relevant and important therapeutic target; success here could be very meaningful for patients and for Arbutus."

ARB-1467

The Company has discontinued development of ARB-1467. Results from the ARB-1467 clinical trials confirmed the potential therapeutic value of an RNAi agent and informed the development of our next-generation RNAi agent, AB-729.
Early R&D Programs

The Company continues a robust discovery effort focused on back-up compounds for its current pipeline as well as discovery efforts focused on reawakening HBV patient’s immune response and on novel HBV-specific targets. These programs include orally available compounds targeting PD-L1 and HBV cccDNA.
Cash Position and 2019 Cash Guidance

The Company ended the year with approximately $125 million in cash, cash equivalents and short-term investments which we believe is sufficient to fund operations into 2020. The Company expects to use approximately $70 to $75 million in cash in 2019.
ONPATTRO Royalty Entitlement

ONPATTRO is an RNAi therapeutic that has been developed for the treatment of hereditary ATTR (hATTR) amyloidosis, and has been approved by the FDA and the EMA. Arbutus has a royalty entitlement on global sales of ONPATTRO for the LNP technology licensed by Arbutus to Alnylam for this product. The Company began recognizing royalty income in 2018. The royalty rate is tiered, based on product sales, and in the low to mid-single digits.

Financial Results

Cash, Cash Equivalents and Investments

As of December 31, 2018, Arbutus had cash, cash equivalents and short-term investments totaling $124.6 million, as compared to $139.0 million in cash and cash equivalents, short-term investments, and restricted investments at December 31, 2017.

Net Loss

For the year ended December 31, 2018, net loss attributable to common shares was $67.2 million ($1.21 basic and diluted loss per common share) as compared to $85.3 million ($1.56 basic and diluted loss per common share) for 2017.

Revenue

Revenue was $5.9 million in 2018 compared to $10.7 million in 2017. The decrease was related primarily to a $7.5 million non-recurring, upfront payment in 2017 from Alexion Pharmaceuticals, Inc. Revenue in 2018 includes $4.3 million pursuant to our license agreement with Gritstone Oncology, Inc.

Research and Development

Research and development expenses were $57.9 million, including $2.7 million of non-cash stock based compensation in 2018 compared to $62.7 million in 2017, including $9.2 million of non-cash stock based compensation. Excluding the decrease in non-cash stock based compensation expense, which was due to the expiry of certain share repurchase rights in 2017, R&D expenses in 2018 have increased as Arbutus’ pipeline expands and advances into the clinic.

General and Administrative

General and administrative expenses were $16.0 million in 2018, including $3.3 million of non-cash stock based compensation compared to $16.1 million in 2017, including $5.9 million of non-cash stock based compensation.

Site Consolidation

Site consolidation expenses were $4.8 million in 2018.

In the first half of 2018, Arbutus substantially completed a site consolidation and organizational restructuring to better align its HBV business in Warminster, PA, by reducing the Company’s global workforce and closing its facility in Burnaby, Canada. We expect related total cash expenditures will be approximately $5.6 million upon completion, of which approximately $4.8 million has been incurred to date.

Impairment of intangible assets

In 2018, the Company recorded a $14.8 million ($10.5 million net of tax benefit) non-cash expense for the impairment of intangible assets related to the indefinite deferral of further development of its AB-423 capsid inhibitor program, due to the successful progression of its AB-506 capsid inhibitor program.

Decrease in fair value of contingent consideration

In 2018 the Company recorded a non-cash decrease in contingent consideration of $7.3 million compared to a $1.4 million increase in 2017.

The decrease in 2018 was due primarily to the Company’s decision to indefinitely defer clinical development of AB-423 thereby reducing the probability of achieving future development milestones, as well as a recalibration in the expected timing of future sales milestones, resulting in a reduction in the estimated fair value of the liability.

Equity investment loss

The Company recorded a gain of $24.9 million on its initial investment in Genevant, a jointly owned company with Roivant Sciences Ltd., and equity losses of $5.6 million for its proportionate share of the Genevant’s net loss. Financial results of Genevant are recorded on a one-quarter lag basis. The Company currently owns approximately 40% of the common equity of Genevant as of December 31, 2018.

Outstanding Shares

The Company had 55.5 million common shares issued and outstanding at December 31, 2018. In addition, the Company had 6.8 million options outstanding and 1.164 million Preferred Shares outstanding, which (including the annual 8.75% coupon) will be mandatorily convertible into 22.6 million common shares on October 18, 2021. Assuming the outstanding options and convertible preferred shares were fully converted, the Company would have had 84.9 million common shares outstanding at December 31, 2018.

Conference Call Today

Arbutus will hold a conference call and webcast today, Thursday, March 7, 2019 at 4:30 PM Eastern Time (1:30 PM Pacific Time) to provide a corporate update. You can access a live webcast of the call through the Investors section of Arbutus’ website at www.arbutusbio.com. Alternatively, you can dial 1-866-393-1607 or 1-914- 495-8556 and reference conference ID 1942769.

An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling 1-855-859-2056 or 1-404-537-3406, and reference conference ID1942769.

On March 7, 2019 Medtronic plc (the "Company") (NYSE:MDT) reported that its wholly-owned subsidiary Medtronic Global Holdings S.C.A. ("Medtronic Luxco") has closed a registered public offering (the "Offering") of €500,000,000 principal amount of Floating Rate Senior Notes due 2021, €1,500,000,000 principal amount of 0.000% Senior Notes due 2021, €1,500,000,000 principal amount of 0.375% Senior Notes due 2023, €1,500,000,000 principal amount of 1.125% Senior Notes due 2027, €1,000,000,000 principal amount of 1.625% Senior Notes due 2031 and €1,000,000,000 principal amount of 2.250% Senior Notes due 2039 (collectively, the "Notes") (Press release, Medtronic, MAR 7, 2019, View Source;p=RssLanding&cat=news&id=2390466 [SID1234534070]). All of Medtronic Luxco’s obligations under the Notes are fully and unconditionally guaranteed by the Company and Medtronic, Inc. ("Medtronic, Inc."), a wholly-owned indirect subsidiary of Medtronic Luxco, on a senior unsecured basis.

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The net proceeds from the Offering will be approximately €6.9 billion, after deducting estimated underwriting discounts and commissions and expenses related to the Offering payable by Medtronic Luxco. The net proceeds of the Offering will be used to fund the previously announced tender offers (the "Tender Offers") for several series of outstanding notes issued by Medtronic, Inc. and Covidien International Finance S.A. ("CIFSA"), a wholly-owned indirect subsidiary of Medtronic plc (together with Medtronic, Inc., the "Offerors"), and to pay accrued and unpaid interest, premiums, fees and expenses in connection with the Tender Offers. Any remaining net proceeds of the Offering will be used for repayment of Medtronic Luxco’s 1.700% senior notes due 2019 at maturity on March 28, 2019 plus accrued and unpaid interest thereon, for payments to be made in connection with the redemption of the Redemption Notes as discussed below and for general corporate purposes.

The Tenders Offers were subject to a financing condition, which condition was satisfied by the closing of the Offering. Following the closing of the Offering, the Offerors accepted for purchase $2.1 billion in aggregate principal amount of the "Any and All Notes" validly tendered and not validly withdrawn on or before 5:00 p.m., New York City time, on March 5, 2019 (the "Early Tender Deadline") and approximately $3.8 billion in aggregate purchase price (excluding accrued and unpaid interest to, but not including, the applicable settlement date and excluding fees and expenses related to the Tender Offers) of the "Maximum Tender Offer Notes" validly tendered and not validly withdrawn on or before the Early Tender Deadline, in each case, in accordance with the press release regarding the pricing terms of the Tender Offers issued on March 6, 2019 (the "Pricing Press Release"). All payments for the Any and All Notes and the Maximum Tender Offer Notes (collectively, the "Tender Offer Notes") purchased in connection with the Early Tender Deadline will also include accrued and unpaid interest on the principal amount of Tender Offer Notes tendered up to, but not including, the early settlement date, which is currently expected to be March 11, 2019.

Although the Tender Offers are scheduled to expire at 12:00 midnight, New York City time, on March 19, 2019 (one minute after 11:59 p.m., New York City time, on March 19, 2019), or any other date and time to which the applicable Offeror extends such Tender Offer, because holders of Maximum Tender Offer Notes subject to the Tender Offers validly tendered and did not validly withdraw Maximum Tender Offer Notes on or prior to the Early Tender Deadline for which the aggregate consideration payable exceeds the Aggregate Maximum Purchase Price, the Offerors do not expect to accept for purchase any tenders of Maximum Tender Offer Notes after the Early Tender Deadline. Holders of Any and All Notes who validly tender such notes following the Early Tender Deadline and at or prior to the applicable expiration date will only receive the applicable Tender Offer Consideration for such Notes accepted for purchase, which is equal to the applicable Total Consideration minus the applicable Early Tender Premium, each as described in the Pricing Press Release.

Today, the Company also announced that it intends to redeem the remaining $0.7 billion in aggregate principal amount of Medtronic, Inc.’s 2.500% Senior Notes due 2020 and $0.2 billion in aggregate principal amount of CIFSA’s 4.20% Senior Notes due 2020 (collectively, the "Redemption Notes") that were not validly tendered on or before the Early Tender Deadline and accepted for purchase, in each case at the redemption prices specified in, and otherwise in accordance with, the indentures governing such Redemption Notes. The redemption date for the Redemption Notes will be April 6, 2019.

Information Relating to the Offering
Barclays Bank PLC and Merrill Lynch International were the joint book-running managers for the Offering. The Offering was made by means of a prospectus and prospectus supplement, copies of which may be obtained for free by visiting EDGAR on the U.S. Securities and Exchange Commission website at www.sec.gov. Alternatively, copies of the prospectus and prospectus supplement for each Offering may be obtained by contacting Barclays Bank PLC, toll free at 1-888-603-5847 and Merrill Lynch International, toll-free at 1-800-294-1322.

Information Relating to the Tender Offers
Barclays Capital Inc. and BofA Merrill Lynch are acting as the dealer managers (the "Dealer Managers") for the Tender Offers. The information agent and tender agent is Global Bondholder Services Corporation ("Global Bondholder"). Copies of the Offer to Purchase and related offering materials are available by contacting Global Bondholder at (866) 470-4200 (U.S. toll-free) or (212) 430-3774 (banks and brokers). Questions regarding the Tender Offers should be directed to Barclays Capital Inc., Liability Management Group at (212) 528-7581 (collect) or (800) 438-3242 (toll free) or BofA Merrill Lynch, Liability Management Group, at (980) 387-3907 (collect) or (888) 292-0070 (toll-free).

None of the Offerors, the Company or their affiliates, their respective boards of directors or managing members, the Dealer Managers, Global Bondholder or the trustee with respect to any series of Tender Offer Notes is making any recommendation as to whether holders of Tender Offer Notes ("Holders") should tender any Tender Offer Notes in response to any of the Tender Offers, and neither the Offerors nor any such other person has authorized any person to make any such recommendation. Holders must make their own decision as to whether to tender any of their Tender Offer Notes, and, if so, the principal amount of Tender Offer Notes to tender.

This press release shall not constitute an offer to sell, a solicitation to buy or an offer to purchase or sell any securities. The Tender Offers are being made only pursuant to the Offer to Purchase and only in such jurisdictions as is permitted under applicable law.

The full details of the Tender Offers, including complete instructions on how to tender Tender Offer Notes, are included in the Offer to Purchase. The Offer to Purchase contains important information that should be read by Holders of Tender Offer Notes before making a decision to tender any Tender Offer Notes. The Offer to Purchase may be downloaded from Global Bondholder’s website at View Source or obtained from Global Bondholder, free of charge, by calling toll-free at (866) 470-4200 (bankers and brokers can call collect at (212) 430-3774).

On March 7, 2019 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel tetracyclines to treat serious and life-threatening conditions, reported that company management will host a conference call at 4:30 p.m. ET on Thursday, March 14, 2019 to discuss fourth quarter and full-year 2018 financial results and provide a general corporate update (Press release, Tetraphase, MAR 7, 2019, View Source [SID1234534086]).

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The conference call may be accessed by dialing 844-831-4023 (U.S. and Canada) or 731-256-5215 (international) and entering conference ID number 4187876. A live audio webcast of the conference call will be available online from the "Investors – Events & Presentations" section of the Tetraphase website at www.tphase.com.

A replay of the conference call will be available from 7:30 p.m. ET on Thursday, March 14, 2019, through 7:30 p.m. ET on Thursday, March 21, 2019 by dialing 855-859-2056 (U.S. and Canada) and 404-537-3406 for (international) callers. The conference ID number is 4187876. A replay of the webcast will be available by visiting Tetraphase’s website.

On March 7, 2019 XOMA Corporation (Nasdaq: XOMA) reported its fourth quarter and full-year 2018 financial results and business highlights (Press release, Xoma, MAR 7, 2019, View Source [SID1234534112]).

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"In 2018, we completed the first transaction under our royalty-aggregator business model, adding seven assets being developed by Merck and Incyte, bringing our royalty license portfolio to 45 assets. We added $20 million of capital and established a $20 million credit facility to strengthen our balance sheet and to continue building our royalty portfolio. We believe XOMA is in a healthy financial position, and we are focused on delivering shareholder value," stated Jim Neal, Chief Executive Officer of XOMA. "In early 2019, we added Barbara Kosacz to our Board of Directors; her legal expertise in analyzing, structuring, and negotiating pharmaceutical and biotechnology license agreements will be invaluable as we execute on our business strategy."

Business Highlights

XOMA continued making significant progress to position the Company for long-term growth, while strengthening its balance sheet in multiple ways during 2018.

Acquired a milestone and royalty interest in seven immuno-oncology assets being developed by Merck and Incyte.

Completed a $20 million rights offering with XOMA stockholders including BVF Partners, LP.

Secured $20 million credit facility with Silicon Valley Bank.

Reduced operating expenses to historic lows, reflecting our new low-cost infrastructure.

Strengthened the Board of Directors and leadership team.

2018 Updates About Partnered Assets in Development

"During its R&D Update on November 25, 2018, Novartis highlighted 26 potential blockbuster drug candidates from their 340 programs under development. XOMA has up to double-digit royalty interests on two of those potential blockbuster assets," concluded Mr. Neal.

Novartis-licensed assets:

Novartis announced gevokizumab will enter oncology clinical studies.

Novartis has listed Phase 2 trials for CFZ533 in four separate indications on ClinicalTrials.gov.

Financial Results

XOMA recorded total revenues of $1.7 million for the fourth quarter of 2018, compared to $5.4 million for the fourth quarter of 2017. For the full year of 2018, XOMA recorded revenues of $5.3 million, compared to $52.7 million for the full year of 2017. Revenues for the full year of 2017 reflect $40.2 million of licenses and collaborative fee revenue received in connection with the Company’s 2017 license agreements with Novartis and a $10.0 million clinical development milestone payment from Novartis related to another therapeutic candidate.

Research and development (R&D) expenses were $0.2 million for the fourth quarter of 2018, compared to $0.7 million for the fourth quarter of 2017. Research and development expenses for the full year of 2018 were $1.7 million, compared to $7.9 million for the same period in 2017. The decrease in R&D expenses for the full year of 2018, as compared with 2017, was primarily due to the implementation of our royalty-aggregator business model during the first quarter of 2017, at which time the Company ceased substantially all development activities. The decrease primarily consisted of $1.9 million in clinical trial costs, $1.4 million in consulting costs, $1.2 million in the allocation of facilities costs, $0.5 million in stock-based compensation, and $0.4 million in salaries and related expenses. The decrease in allocation of facilities costs is a result of a decreased proportion of R&D employees due to our restructuring activities in late 2016 and June 2017.

General and administrative (G&A) expenses were $4.3 million for the fourth quarter of 2018, compared to $6.7 million for the fourth quarter of 2017. General and administrative expenses were $18.6 million for the full year of 2018, compared to $24.3 million for the full year of 2017. The decrease of $5.7 million for the full year of 2018, as compared with the full year of 2017, was primarily due to decreases of $2.9 million in stock-based compensation, $2.1 million in consulting services, and $0.5 million in information technology costs, partially offset by an increase of $1.2 million in the allocation of facilities costs due to a greater proportion of G&A personnel compared to R&D personnel after our restructuring activities.

For the years ended December 31, 2018 and 2017, XOMA recorded $1.9 million and $3.4 million, respectively in charges related to severance, other termination benefits, outplacement services, and lease-related charges associated with restructuring activities.

For the years ended December 31, 2018 and 2017, XOMA recorded other income of $4.3 million and $1.1 million, respectively. Other income in both periods included income received in relation to the Company’s disposition of its biodefense business to Ology Bioservices in March 2015. During the year ended December 31, 2018, XOMA also received $1.8 million in sublease income. This was partially offset by a loss of $0.6 million for the decrease in fair value of long-term equity securities that consisted of shares of Rezolute’s common stock. For the year ended December 31, 2017, XOMA realized a foreign exchange loss of $1.6 million related to re-measurement of the Servier Loan which was paid in 2017 and a sublease loss of $0.8 million, offset by a $1.2 million gain on the sale and disposal of equipment located in one of its leased facilities.

Net loss for the fourth quarter of 2018 was $3.0 million, compared to net loss of $1.3 million for the fourth quarter of 2017. Net loss for the full year of 2018 was $13.3 million, compared to net income of $14.6 million for the full year of 2017. The significant net income for the full year of 2017 was due primarily to the increase in total revenues as previously discussed.

On December 31, 2018, XOMA had cash and cash equivalents of $45.8 million. The Company ended December 31, 2017, with cash and cash equivalents of $43.5 million. The Company’s current cash and cash equivalents are expected to be sufficient to fund its operations for multiple years.