On May 12, 2021 MannKind Corporation (Nasdaq:MNKD) reported financial results for the quarter ended March 31, 2021 (Press release, Mannkind, MAY 12, 2021, View Source [SID1234579793]).

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"We started 2021 by taking advantage of favorable market conditions to strengthen our financial position with the issuance of $230 million of senior convertible notes, which provides our current and future partners with greater confidence in our company," said Michael Castagna, Chief Executive Officer of MannKind Corporation. "The capital raised allows us to reduce our legacy debt, advance our pipeline and grow Afrezza. In the first quarter of 2021, the underlying demand for paid Afrezza prescriptions grew in the mid-single digits year over year."

Total revenues were $17.4 million for the first quarter of 2021, an increase of $1.2 million, or 7%, reflecting Afrezza net revenue of $8.1 million and collaboration and services revenue of $9.3 million. Afrezza net revenue increased 1% compared to $8.0 million in the first quarter of 2020. Collaboration and services revenue for the first quarter of 2021 increased $1.1 million compared to the first quarter of 2020, primarily due to additional pass-through costs associated with the UT license agreement and the launch of the Vista Pharma Co-promotion Agreement for Thyquidity.

Afrezza gross profit for each of the first quarters of 2021 and 2020 was $3.8 million. Cost of goods sold increased by $0.2 million compared to the same period in 2020, which was offset by the increase in net revenues discussed above. Gross margin in the first quarter of 2021 was 47% compared to 48% for the same period in 2020.

Research and development expenses for the first quarter of 2021 were $2.4 million compared to $1.8 million for the first quarter of 2020. This increase of $0.7 million, or 39%, was attributable to personnel costs primarily related to increased headcount for research and development, regulatory and medical affairs.

Selling, general and administrative expenses for the first quarter of 2021 were $17.4 million compared to $14.4 million for the first quarter of 2020. This increase of $3.1 million, or 21%, was primarily due to a $2.3 million increase in personnel costs primarily related to increased headcount for our Afrezza commercial team, $0.3 million in patient support services and $0.3 million in promotional and marketing activities.

For the first quarter of 2021, the gain on foreign currency translation for insulin purchase commitments denominated in Euros was $3.8 million compared $1.8 million for the first quarter of 2020. The fluctuation was due to the change in the U.S. dollar to Euro foreign exchange rate. Interest expense on debt for the first quarter of 2021 was $6.5 million compared to $2.3 million for the first quarter of 2020. This increase of $4.1 million was due to a $3.7 million milestone obligation that was achieved during the quarter and interest expense from the senior convertible notes and the MidCap credit facility.

The net loss for the first quarter of 2021 was $12.9 million, or $0.05 per share, compared to a $9.3 million net loss in the first quarter of 2020, or $0.04 per share. The increased net loss of $3.6 million was primarily due to the increase in interest expense, selling, general and administrative expenses, and research and development expense, all of which were partially offset by an increase in the gain on foreign currency translation.

Cash, cash equivalents, and investments at March 31, 2021 were $278.3 million compared to $67.0 million at December 31, 2020. The increase in cash, cash equivalents and investments was primarily due to the issuance of $230.0 million of 2.5% senior convertible notes.

Debt Reductions Subsequent to March 31, 2021

In April 2021, the Company repaid $35.1 million outstanding principal under the Mann Group non-convertible promissory note plus $4.9 million of accrued and unpaid interest to the Mann Group. In addition, the Company repaid $10.0 million outstanding principal under the MidCap credit facility.

Conference Call

MannKind will host a conference call and presentation webcast to discuss these results today at 5:00 p.m. Eastern Time. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at www.mannkindcorp.com under Events & Presentations. A replay will be available on MannKind’s website for 14 days.

On May 12, 2021 Magenta Therapeutics (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplants to more patients, reported positive preliminary results from its Phase 2 clinical trial of MGTA-145 plus plerixafor in patients with multiple myeloma, which were accepted for presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress, to be held virtually June 9-17, 2021 (Press release, Magenta Therapeutics, MAY 12, 2021, View Source [SID1234579792]). Magenta also provided initial direction regarding the acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) patients it expects to evaluate in its planned clinical trial with MGTA-117.

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Multiple Myeloma Phase 2 Clinical Trial

The investigator-initiated, 25-patient Phase 2 open-label clinical trial, ongoing at Stanford University School of Medicine, is designed to evaluate the ability of MGTA-145, in combination with plerixafor, to mobilize and collect stem cells for autologous stem cell transplant in patients with multiple myeloma.

Preliminary results:

All patients (10/10) met the primary endpoint of mobilization and collection of 2 million CD34+ stem cells per kg in up to two days of same-day mobilization and apheresis. Nine of 10 patients achieved the primary endpoint in a single day.
The median number of stem cells collected in one day was 5.4 million CD34+ stem cells per kg.
Patients could also be successfully mobilized and apheresed on a second day, if needed, based upon protocol requirements. The median number of stem cells collected on day 1 and 2 (if needed) was 7.1 million CD34+ stem cells per kg in all patients. Current standard of care with G-CSF regimens require a minimum of five days of dosing to initiate stem cell collection.
All transplanted patients (6/6) successfully engrafted, with median recovery of neutrophils after 12 days and platelets after 17 days, which are within transplant expectations in multiple myeloma.
The CD34+ stem cells collected were enriched for CD90 expression (31% of CD34 cells were CD34+CD90+), a stem cell population associated with durable engraftment, which is three-fold greater than observed with G-CSF historically.
The regimen of MGTA-145 and plerixafor was well tolerated. Acute, transient, MGTA-145-related grade 1 bone or musculoskeletal pain was observed in 40% of patients following MGTA-145 infusion.
This study has broad and clinically representative inclusion criteria and is enrolling patients that represent the general transplant eligible population of patients with multiple myeloma, some of whom may have additional risk factors that may impact stem cell collection. Risk factors can include myeloma-directed therapies that are known to impact stem cell collection, previous malignancy treated with chemotherapy and/or radiation and other co-morbid conditions. Mobilization agents may be less effective in patients with multiple risk factors.

"These preliminary results are encouraging, given the expected mobilization challenges present in the multiple myeloma patient population," said Jason Gardner, D.Phil., President and Chief Executive Officer, Magenta Therapeutics. "A patient’s ability to mobilize is highly contingent on a variety of risk factors, which is particularly relevant for blood cancer patients. These initial results provide insight into MGTA-145 plus plerixafor’s ability to improve the approach to mobilization and collection, and its potential to be a first-line mobilization drug in this and other disease areas."

"Based on this initial data set, MGTA-145 combined with plerixafor has shown promising results for rapid stem cell mobilization in patients with multiple myeloma," said John Davis Jr., M.D., M.P.H., M.S., Head of Research & Development and Chief Medical Officer, Magenta Therapeutics.

This study is being conducted at Stanford University School of Medicine and is led by Surbhi Sidana, M.D., Assistant Professor of Medicine in the Division of Blood and Marrow Transplantation and Cellular Therapy at Stanford Medicine.

EHA Poster Presentation (June 11, 2021)
Title: Phase 2 Study of MGTA-145 + Plerixafor for Rapid and Reliable Hematopoietic Stem Cell (HSC) Mobilization for Autologous Stem Cell Transplant in Multiple Myeloma
Author: Surbhi Sidana, M.D., Assistant Professor of Medicine in the Division of Blood and Marrow Transplantation and Cellular Therapy, Stanford University School of Medicine
Date/Time: E-posters to be available in the EHA (Free EHA Whitepaper) Congress virtual platform Friday, June 11 at 3:00am EDT / 9:00am CEST.

This trial continues to enroll patients and Magenta expects to report additional data at the EHA (Free EHA Whitepaper) Congress, as well as at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held virtually June 4-8, 2021.

Conference Call & Webcast Details

The Company will host a conference call and webcast today at 4:30pm EDT to review the preliminary results from the multiple myeloma Phase 2 clinical trial. The live webcast of the conference call may be accessed by visiting the "Events & Presentations" page in the Investors & Media section of the Magenta Therapeutics website at View Source The live teleconference may be accessed by dialing (866) 688-5232 (domestic) or (409) 217-8328 (international) and entering conference ID: 7273937. An archived version of the call will be available on the website for 90 days.

Planned MGTA-117 Clinical Study

Magenta is on track to file an Investigational New Drug (IND) application for MGTA-117, a potential first-in-class drug for targeted patient conditioning, in June 2021. In preparation for the filing, Magenta has finalized its proposed clinical trial study design which incorporates FDA feedback from pre-IND communications. Magenta anticipates starting the Phase 1/2 dose escalation study by evaluating the safety, pharmacokinetics and pharmacodynamics of MGTA-117 as a single agent in a relapsed/refractory AML and MDS patient population. Magenta will also monitor for anti-tumor activity in this patient subset, which is a population that is not traditionally eligible for stem cell transplant. Magenta expects to work with the FDA on an ongoing basis to transition the study to transplant-eligible patients after adequate data related to the safety, pharmacokinetics and pharmacodynamics of MGTA-117 have been collected in the relapsed/ AML and MDS patient population.

On May 12, 2021 Magenta Therapeutics, Inc. (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplant to more patients, reported that it has agreed to sell approximately 9,600,000 shares of its common stock to certain institutional investors in a private placement (Press release, Magenta Therapeutics, MAY 12, 2021, View Source [SID1234579791]). Magenta anticipates aggregate gross proceeds from the offering will be $86.4 million, before deducting estimated offering expenses payable by the Company, based on the offering price of $9.00 per share. The financing syndicate includes Deep Track Capital, L.P., TCG X, Great Point Partners, LLC, OrbiMed and Janus Henderson Investors. The closing is anticipated to occur on May 14, 2021, subject to customary closing conditions. Magenta intends to use the net proceeds from the offering for general corporate purposes and working capital.

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The securities are being sold in a private placement and have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. The Company has agreed to file a resale registration statement with the Securities and Exchange Commission (the "SEC"), for purposes of registering the resale of the shares of common stock issued or issuable in connection with the offering.

Important Information

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or 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. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

On May 12, 2021 Labcorp (NYSE: LH) ("Labcorp") reported that it plans to offer, subject to market and other conditions, senior notes that are expected to be issued in two tranches (the "Notes") (Press release, LabCorp, MAY 12, 2021, View Source [SID1234579790]). The Notes will be senior unsecured obligations and will rank equally with Labcorp’s existing and future senior unsecured debt.

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Labcorp expects to use the net proceeds of the Notes offering to redeem, prior to maturity, its outstanding 3.20% Senior Notes due Feb. 1, 2022 and 3.75% Senior Notes due Aug. 23, 2022.

The joint book-running managers for the offering are BofA Securities, KeyBanc Capital Markets, and Wells Fargo Securities. The offering will be made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-234633) filed with the Securities and Exchange Commission (the "SEC") on Nov. 12, 2019. A copy of the prospectus and related prospectus supplement may be obtained without charge from the SEC. Alternatively, a copy of the prospectus and related prospectus supplement may be obtained from BofA Securities by calling toll-free 1-800-294-1322, from KeyBanc Capital Markets by calling toll-free 1-866-227-6479, or from Wells Fargo Securities by calling toll-free 1-800-645-3751.

This announcement does not constitute an offer to sell or a solicitation of an offer to buy the Notes or any other securities, nor shall there be any sale of these securities in any jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The offering of these securities may be made only by means of the prospectus supplement and the accompanying prospectus.

On May 12, 2021 Kuraray reported that Financial Results for the First Quarter of the Fiscal Year Ending December 31, 2021 (January 1, 2021 to March 31, 2021) (Press release, Kuraray, MAY 12, 2021, https://pdf.irpocket.com/C3405/eq9A/Kj61/GizM.pdf [SID1234579789])

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1. Consolidated Financial Results for the First Quarter of the Fiscal Year Ending December 31, 2021 (January 1, 2021 to March 31, 2021)

(1) Consolidated Operating Results (Percentage changes displayed for net sales, operating income, ordinary income and net income attributable to owners of the parent are comparisons with the corresponding period of the previous fiscal year.)

(2) Consolidated Financial Position2. Dividends 3. Forecasts of Consolidated Financial Results for the Fiscal Year Ending December 31, 2021 (January 1, 2021 to December 31, 2021) (Percentage changes displayed for net sales, operating income, ordinary income and net income attributable to owners of the parent are comparisons with the corresponding period of the previous fiscal year.)

1. Qualitative Information regarding Business Results
1) Overview of Consolidated Business Results In the first quarter of fiscal 2021 (January 1, 2021–March 31, 2021), the world economy is still feeling the effects of the COVID-19 pandemic, and the outlook remains unclear. Amid these circumstances, the Group’s business results continued to recover owing to an increase in demand for at-home consumption due to the pandemic and an increase in automotive-related demand.

Consequently, consolidated operating results for the first quarter of fiscal 2021 are as follows: net sales rose ¥7,470 million, or 5.5%, compared with the previous fiscal year to ¥144,398 million; operating income increased ¥4,814 million, or 40.2%, to ¥16,786 million; ordinary income increased ¥4,962 million, or 43.9%, to ¥16,268 million; and net income attributable to owners of the parent decreased ¥1,422 million, or 21.2%, to ¥5,282 million. Furthermore, in the first quarter, we recorded a loss on litigation of ¥3,054 million related to a fire that occurred at our U.S. subsidiary in May 2018. We also recorded a disaster loss of ¥3,016 million due mainly to the suspension of production for some equipment at our U.S. subsidiary caused by a severe cold wave in the southern United States in February.

The Group’s long-term vision for its 100th anniversary coming up in 2026, Kuraray Vision 2026, is to become a "Specialty Chemical Company, growing sustainably by incorporating new foundational platforms into its own technologies." We will continue striving to optimize our business portfolio by steadily taking specific measures based on the three basic policies of Kuraray Vision 2026: pursuing competitive superiority, expanding new business fields and enhancing comprehensive strength of the Kuraray Group. We formulated a single-year management plan for fiscal 2021 and will focus on safe and stable operations amid the pandemic as well as thoroughly implement various measures decided on during the period of the previous medium-term management plan "PROUD 2020." At the same time, we will move ahead with formulating the next medium-term management plan, which is set to start in fiscal 2022. In the Functional Materials segment, due to an organizational reform on January 1, 2021, we integrated the Calgon Carbon Division and Carbon Materials Division, whose core products are activated carbon, into the Environmental Solutions Division. Results by Business Segment Vinyl Acetate Sales in this segment increased 13.0% year on year to ¥72,175 million, and segment income rose 59.9% year on year to ¥13,415 million

(1) Sales of PVA resin increased as global demand began to recover though overall business was affected by the U.S. cold wave. Sales of optical-use poval film were brisk due to an increase in demand for LCD panels, especially large displays, from the second half of the previous fiscal year. The sales volume of PVB film rose on the back of a recovery in demand for both construction and automotive applications. Sales of water-soluble PVA film steadily expanded for use in unit dose detergent packets, including for dish detergents, as more customers stay at home due to the COVID-19 pandemic.

(2) The sales volume of EVAL ethylene vinyl alcohol copolymer (EVOH resin) increased as food packaging applications remained firm and demand for gas tank applications recovered, but overall performance was affected by the U.S. cold wave. Isoprene Sales in this segment increased 13.2% year on year to ¥14,894 million, and segment income fell 3.0% year on year to ¥3,046 million.

(1) The sales volume of isoprene chemicals and SEPTON thermoplastic elastomer increased by a demand recovery mainly in China and the rest of Asia, but performance was affected by higher raw material and fuel prices.2) Sales of GENESTAR heat-resistant polyamide resin remained brisk for electric and electronic device applications and automotive applications amid growing demand. Functional Materials Sales in this segment decreased 1.5% year on year to ¥30,294 million, and segment income fell 16.3% year on year to ¥1,061 million.

(1) In the methacrylate business, sales for sign applications were weak despite an increase in sales of spatter-blocking barrier panels and displays.
(2) In the medical business, the dental materials business saw brisk sales, mainly in Europe and the United States.
(3) In the environmental solutions business, shipments decreased, especially for industrial applications. Fibers and Textiles Sales in this segment fell 5.2% year on year to ¥13,721 million while segment income decreased 52.4% year on year to ¥435 million

1) Sales of CLARINO man-made leather remained stable amid signs of a recovery in demand, especially for shoe applications in Asia and luxury good applications in Europe
2) In fibers and industrial materials, sales of KURALON were lower than the previous year despite a recovery in demand, which had fallen in the second half of the previous year
3) In consumer goods and materials, the sales volume of KURAFLEX decreased as 5 demand for counter cloths for the restaurant industry remained weak despite an increase in sales volume for mask-related applications.Trading In fiber-related businesses, sales stagnated, especially for sports clothing. Sales of resins and chemicals remained favorable due to an increase in demand in Japan and Asia, including China. As a result, segment sales increased 10.8% year on year to ¥32,972 million, and segment income rose 11.8% to ¥1,074 million

(2) Overview of Financial Position Total assets decreased ¥2,877 million from the end of the previous fiscal year to ¥1,048,707 million mainly because of a ¥30,184 million decrease in cash and cash deposits and a ¥5,794 million decrease in short-term investment securities, despite a ¥6,845 million increase in construction in progress, a ¥5,067 million increase in notes and accounts receivable-trade, a ¥4,615 million increase in inventories, a ¥4,608 million increase in machinery, equipment and vehicles, a ¥3,314 million in other current assets accompanying mainly an increase in other accounts receivable, and a ¥2,410 million increase in goodwill due to the effects of foreign exchange rates. Total liabilities decreased ¥25,709 million to ¥510,394 million due to factors that included the redemption of commercial paper totaling ¥20,000 million and a ¥11,684 million decrease in other current liabilities accompanying mainly a decrease in otheraccounts payable, despite a ¥3,626 million increase in notes and accounts payable–trade. Net assets rose ¥22,831 million to ¥538,312 million. Equity attributable to owners of the parent amounted to ¥520,151 million, for an equity ratio of 49.6%.

(3) Basis for the Revision in Forecasts, Including Consolidated Operating Results Forecasts In the consolidated first quarter, shipments in many of Kuraray’s businesses increased due to growth in demand, including for mainstay applications for automobiles, displays, and electronic and electric devices. We assume that demand will remain firm in the second quarter as well. Based on these circumstances, the forecast of consolidated operating results for the second quarter of fiscal 2021 (January 1, 2021 to June 30, 2021) is as shown below. The revised cumulative consolidated operating results forecast for the second quarter of the fiscal year ending December 31, 2021 (January 1, 2021 to June 30, 2021) is as follows.

Furthermore, although we recorded an extraordinary loss in the consolidated first quarter related to the litigation over the fire at the U.S. subsidiary, the litigation is still ongoing.