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Business Healthcare

Melinta Therapeutics announces appointment of Peter Piliero as Vice President of Medical Affairs

MORRISTOWN, N.J. — (BUSINESS WIRE) — Melinta Therapeutics, LLC (“Melinta”), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, announces the appointment of Dr. Peter Piliero as Vice President of Medical Affairs, effective March 14.

Dr. Piliero, an Infectious Disease specialist and global Medical Affairs leader, joins Melinta under the leadership of President and Chief Executive Officer Christine Ann Miller. In this role, Dr. Piliero will be responsible for the development and implementation of integrated medical plans for Melinta’s portfolio. Additionally, Dr. Piliero will help Melinta continue to stand out as a thought leader in the important conversations happening in scientific and medical communities today.

 

“As Melinta continues its legendary journey serving patients with critical, unmet needs, I am excited to welcome Pete to the team. With his depth of medical and scientific experience and proven track record leading high-performing teams, I know he’ll be an incredible asset in driving growth and guiding Melinta’s public discussions as we shape the future of acute care,” Ms. Miller said.

 

Dr. Piliero joins Melinta from GSK Consumer Healthcare, where he led Medical Affairs Americas. Prior to that role, he held significant clinical and leadership positions at Boehringer Ingelheim, Merck and Mallinckrodt. At these organizations, he led global Medical Affairs teams in various therapeutic areas, including Virology, Immunology, CNS, Metabolism and Women’s Health.

 

Prior to joining the pharmaceutical industry, Dr. Piliero was Associate Professor of Medicine at Albany Medical College. He practiced there for 11 years as an Infectious Disease and HIV specialist, providing patient care and directing the Clinical Pharmacology Studies Unit.

 

Since 2017, Dr. Piliero has been an active member of the Medical Affairs Professional Society. He is currently a member of the Board of Directors and the Vice Chair of the Executive Committee.

 

“I am honored to work alongside this truly committed team to achieve our vision – ensuring that all patients with life-threatening illnesses who need our innovative therapies will receive them,” Dr. Piliero said. “I look forward to developing and executing strategic medical plans, leading scientific communications, generating new evidence, and ensuring trusted communications with external stakeholders to pave the way for improved patient outcomes.”

 

About Melinta Therapeutics

Melinta Therapeutics, LLC provides innovative therapies to people impacted by acute and life-threatening illnesses. Our portfolio currently includes five commercial-stage antibiotics: Baxdela® (delafloxacin), Kimyrsa™ (oritavancin), Minocin® (minocycline) for Injection, Orbactiv® (oritavancin), and Vabomere® (meropenem and vaborbactam). With an unsurpassed commitment to providers and the patients they serve, we work to ensure that all people who need our therapies can receive them. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. Visit www.melinta.com for more information.

Contacts

Susan Blum

(312) 767-0296

info@melinta.com

Categories
Business

Toorak Capital Partners closes $285M residential bridge and $363M DSCR securitizations

SUMMIT, N.J. — (BUSINESS WIRE) — Toorak Capital Partners, Inc. (“Toorak”), a leading capital provider to the residential real estate lending industry, today announced the successful closing of TRK 2022-1, a $285 million securitization of residential bridge loans, following the closing of TRK 2022-INV1, a $363 million securitization of DSCR loans last month.

Toorak’s securitizations received investor demand despite a volatile and oversupplied market. To date, the company has issued $2.7+ billion in securitizations across nine deals, including six revolving transactions backed by bridge loans and three rated transactions backed by long-term investor loans on rental properties.

 

“We are focused and proud of the social impact Toorak has had,” said Toorak CEO John Beacham. “In addition to aiding in the delivery and availability of units to the market, many of which are affordable, Toorak’s funding brings jobs and opportunities to areas that are often neglected by large investors. Our bridge loan borrowers are entrepreneurs who invest the funds we provide to hire and employ local workers, many with untraditional backgrounds and in low-income neighborhoods.”

 

The initial collateral underlying the TRK 2022-1 securitization consisted of 583 residential bridge loans that financed approximately 1,300 housing units, 78% of which are expected to be affordable upon rehabilitation and/or stabilization in their respective zip codes, where the median household income was close to $55,900.

 

The TRK 2022-INV1 securitization consisted of 1,254 rental mortgages that financed around 2,300 units, with an average underwritten rent of approximately $1,600 per unit, compared to a median household income of $55,700 in their respective zip codes.

 

With capital commitments from entities managed by KKR, a leading global investment firm, Toorak has revolutionized the way business purpose residential real estate lenders access capital. The firm was the first to link small-balance commercial and residential originators with institutional capital and has perfected this approach in the single-family residential bridge and 30-year single family rental lending space.

 

About Toorak Capital Partners

Toorak Capital Partners is an integrated correspondent lending platform based in Summit, NJ. Toorak acquires small-balance, business-purpose loans backed by residential, multifamily, and mixed-use properties throughout the U.S. and the U.K. Toorak acquires loans directly from lenders that originate high credit quality loans. Toorak’s principals have a deep understanding of mortgage credit in the residential and commercial space with backgrounds in real estate lending, capital markets, securitization, asset-liability management, asset management and credit. Since inception, Toorak has provided more than $7.5 billion in capital and funded over 20,000 business-purpose loans. Toorak-funded projects have renovated, stabilized or provided rental housing for close to 40,000 families to date – an average of approximately 1,000 families per month in 2021.

 

Further information is available at www.toorakcapital.com.

Contacts

Media:

Alex Varney, Stanton

avarney@stantonprm.com
646-502-3565

Categories
Business Technology

Connect with ASCO Power Technologies at Electro Expo 2022

  • ASCO Power will show its latest critical power innovations through its Digital Hub at Electro Expo 2022 in Cleveland, Ohio.
  • The ASCO Power Digital Hub lets attendees electronically access ASCO’s digital product and service information and witness critical power equipment in operation via virtual reality technology.
  • Attendees can connect with ASCO experts who can explain critical power concepts and optimize critical power solutions

 

FLORHAM PARK, N.J. — (BUSINESS WIRE) — ASCO Power Technologies, the world’s leading provider of critical power solutions, will highlight its latest innovations at the Electro Expo 2022 in March. Attendees can meet seasoned ASCO experts and experience the ASCO Digital Hub that shows how ASCO critical power equipment solutions benefit facilities across a range of industries.

The event will be held on March 30 and 31, 2022, at the Huntington Convention Center in Cleveland, Ohio, USA. The event is FREE to power industry professionals including engineers, facility managers, contractors, and technicians.

 

The ASCO Power Digital Hub features the entire range of ASCO Power products from transfer switches to industrial control products. Its Interactive 3D Facility enables attendees to take a close look at equipment and learn how ASCO solutions improve power reliability and streamline compliance. The hub’s Video Library presents critical power summaries, FAQs, and expert perspectives. Using the hub’s virtual reality tools, attendees can operate ASCO critical power equipment and see power devices in operation to learn how ASCO solves backup power challenges in Data Centers, Telecommunication Hubs, Healthcare Facilities, and more By visiting the ASCO exhibit, attendees can:

  • Learn about the latest ASCO technologies, products, solutions, and applications
  • Get a closer look at equipment through our digital tools and 360-degree videos
  • Network with ASCO experts and industry peers

 

Visit the ASCO Events page for registration information and event details.

 

ASCO critical power solutions are backed by technology, support, and service that are unmatched in the industry. Visit www.ascopower.com or contact an ASCO representative to learn more about ASCO products and services.

 

About ASCO Power Technologies

ASCO Power Technologies has provided power reliability solutions for more than 125 years. The firm designs, manufactures, services, and supports automatic transfer switches, power control equipment, load banks, and critical power management appliances. ASCO products serve mission-critical functions in data centers, healthcare facilities, telecommunication networks, commercial buildings, and industrial operations. To learn more about any of ASCO’s premium products and services, call (800) 800 ASCO (2726), email CustomerCare@Ascopower.com, or visit www.ascopower.com. To receive updates on the latest news and updates, follow ASCO’s Facebook and LinkedIn.

Contacts

Laurence Grodsky

+ 1 973 307 7352

Larry.Grodsky@ascopower.com

Categories
Business

Best’s Insurance Law Podcast: The use of smart home data in fire scene investigations and claims

OLDWICK, N.J. — (BUSINESS WIRE) — AM Best and Best’s Insurance Professional Resources have released the latest installment of the Best’s Insurance Law Podcast series, which examines timely insurance issues from a legal perspective.

This episode looks at how smart home data is utilized in fire scene losses for liability defense.

 

The podcast features Nick Mahoney from expert service provider S-E-A. Mr. Mahoney is a licensed Professional Engineer (P.E.) in multiple states. He is a Certified Fire and Explosion Investigator (CFEI) through the National Association of Fire Investigators.

 

S-E-A is a qualified member of Best’s Insurance Professional Resources, an insurance industry resource that has featured qualified legal counsel, independent insurance adjusting services and expert service providers since 1929.

 

Listen or subscribe to the Insurance Law Podcast.

 

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

Copyright © 2022 by A.M. Best Company, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Christopher Sharkey
Manager, Public Relations
+1 908 439 2200, ext. 5159
christopher.sharkey@ambest.com

Jim Peavy
Director, Communications
+1 908 439 2200, ext. 5644
james.peavy@ambest.com

Categories
Business

AM Best assigns Issue Credit Ratings to Manulife Financial Corporation’s new senior unsecured notes and New shelf registration

OLDWICK, N.J. — (BUSINESS WIRE) — #insuranceAM Best has assigned Long-Term Issue Credit Ratings (Long-Term IR) of “a-” (Excellent) to the recently announced $750 million of 3.703% senior unsecured notes, due 2032. Concurrently, AM Best has assigned indicative Long-Term IRs of “a-” (Excellent) to senior unsecured issues, “bbb+” (Good) to subordinated issues and “bbb” (Good) to preferred securities issues to the recently filed shelf registration of Manulife Financial Corporation (MFC) (Toronto, Canada). The outlook assigned to these Credit Ratings (ratings) is stable.

The senior unsecured notes were issued as senior unsecured green notes, and MFC intends to use the proceeds to finance or refinance, in part or full, new or existing eligible green assets. Additionally, with the issuance of the senior unsecured notes and recent redemption of its Class 1 Series 23 and Series 7 preferred shares, MFC’s financial leverage and interest coverage ratios remain within an appropriate range for the company’s current ratings.

 

This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper use of Best’s Credit Ratings, Best’s Performance Assessments, Best’s Preliminary Credit Assessments and AM Best press releases, please view Guide to Proper Use of Best’s Ratings & Assessments.

 

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

 

Copyright © 2022 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Shauna Nelson
Senior Financial Analyst
+1 908 439 2200, ext. 5365
shauna.nelson@ambest.com

Christopher Sharkey

Manager, Public Relations
+1 908 439 2200, ext. 5159
christopher.sharkey@ambest.com

Michael Adams
Associate Director
+1 908 439 2200, ext. 5133
michael.adams@ambest.com

Jim Peavy
Director, Communications
+1 908 439 2200, ext. 5644

james.peavy@ambest.com

Categories
Business Technology

ASCO Power Technologies solves load testing challenges for a major social media provider

  • A social media provider expanded added multiple data centers to meet user demands
  • The customer needed unique load bank features to streamline data center construction, commissioning, and period testing
  • ASCO Power developed a standard design for use from across the company’s expanding data center network

 

FLORHAM PARK, N.J. — (BUSINESS WIRE) — A major social media provider required greater capacity to meet the demands of its growing social communities. The company responded by constructing and commissioning multiple hyperscale data centers. ASCO Power Technologies, the company’s exclusive load solution supplier, helped it solve load testing challenges as it expanded its network operations.

The latest Case Study summarizes the customer’s challenges, which requires unique approaches in load test protocols and equipment, and explains how the firm turned to ASCO Power for advanced support. ASCO provide a solution that could be deployed from facility to facility.

 

ASCO Power provided the firm with SIGMA Network Pro software to setup load banks, test systems, record data, and evaluate the results. The provider also started using ASCO portable Load Banks to execute tests and meet commissioning needs for facilities with different climates or applications.

 

The customer standardized its permanent load bank installations on designs such as the ASCO 2755. It provides the rugged reliable service needed to maintain stringent test programs that enhance power reliability. The customer found the load bank for its facility in ASCO’s extensive load bank range, which includes models that mount on engine radiators, floor slabs, concrete pads, and more.

 

ASCO Power is proud of its role in helping this customer expand operations to bring reliable communication to the next generation of social media users. More information about the challenge, the solution, and the outcome is available on the ASCO Power Technologies website.

 

Read the Case Study here: ASCO Power Case Study | Load Testing for a Global Social Media Provider

 

About ASCO Power Technologies

ASCO Power Technologies has provided power reliability solutions for more than 125 years. The firm designs, manufactures, services, and supports automatic transfer switches, power control equipment, load banks, and critical power management systems. ASCO products serve mission-critical functions in data centers, healthcare facilities, telecommunication networks, commercial buildings, and industrial operations. To learn more about any of ASCO’s premium products and services, call (800) 800 ASCO (2726), email CustomerCare@Ascopower.com, or visit www.ascopower.com. To receive updates on the latest news and updates, follow ASCO’s Facebook and LinkedIn.

Contacts

Laurence Grodsky

+ 1 973 307 7352

Larry.Grodsky@ascopower.com

Categories
Business

Daikin Subsidiary enters into definitive agreement to acquire CCOM Group, Inc. for distribution in New Jersey and surrounding states

WALLER, Texas & HAWTHORNE, N.J. — (BUSINESS WIRE) — #HVAC–Goodman Distribution, Inc., a subsidiary of Daikin, has entered into a definitive agreement to acquire CCOM Group, Inc. (OTC Pink: “CCOM”, “CCOMP”) and its wholly owned subsidiaries for $2.71 per share of common stock and convertible preferred stock, the companies jointly announced today. Goodman Distribution, Inc. will change its name to Daikin Comfort Technologies Distribution, Inc. on April 1.


CCOM’s subsidiaries, Universal Supply Group, Inc., RAL Supply Group, Inc., and S&A Supply, Inc., have shaped it into a leading full line distributor of HVAC products, building management systems, plumbing and electrical supplies, and parts and accessories in the Northeastern United States. The transaction is expected to close in the first half of the year, subject to customary closing conditions.

 

“I am incredibly excited to have CCOM and its companies join us on our journey to becoming North America’s clear leader in indoor comfort solutions,” said Takayuki “Taka” Inoue, Daikin Executive Vice President and Chief Sales and Marketing Officer.

 

“The acquisition of CCOM supports our strategy of continued commitment and growth in the region and is integral to our distribution expansion efforts in the Northeast,” said Ardee Toppe, Daikin Senior Vice President.

 

The announcement follows Daikin’s acquisition of Pacific Northwestern companies Thermal Supply, Inc. and AirReps, LLC in December, and other recent acquisitions including ABCO HVACR Supply + Solutions, Robinson Plumbing & Heating Supply, Co., Inc., Thermal Mechanics Inc. (TMI), and Stevens Equipment Supply.

 

“Combining our unique strengths as a multi-branded Technical Supply House with the largest HVAC manufacturer in the world is clearly the best way for us to deliver on our aggressive growth plans,” said Pete Gasiewicz, CCOM CEO. “This alignment solidifies our longstanding relationship and gives us the best opportunity to serve our contractors in a very competitive region.”

 

CCOM will continue to supply and promote the full line of residential unitary Goodman and Amana® brand equipment and Daikin ductless and light commercial HVAC products, as well as a diverse lineup of additional brands and products. This includes building management systems and controls, other HVAC, indoor air quality, hydronic, plumbing and electrical equipment and supplies throughout its 15 locations across New Jersey, New York and Massachusetts.

 

Following the closing of the transaction, CCOM and its subsidiaries will operate as a wholly owned business unit of Goodman, while maintaining headquarters in Hawthorne, New Jersey with more than 165 employees.

 

About Daikin

Daikin Industries, Ltd. (DIL) is a Fortune 1,000 company with more than 84,870 employees worldwide and is the world’s #1 indoor comfort solutions provider company. Daikin Comfort Technologies North America (DNA), Inc is a subsidiary of DIL, providing Daikin, Goodman, Amana® and Quietflex brands products. DNA and its affiliates manufacture heating and cooling systems for residential, commercial and industrial use and are sold via independent HVAC contractors. DNA engineering and manufacturing is located at Daikin Texas Technology Park near Houston, Texas. For additional information, visit https://www.northamerica-daikin.com/.

 

Amana® is a registered trademark of Maytag Corporation or its related companies and is used under license. All rights reserved.

 

About CCOM Group

CCOM Group, Inc., based in Hawthorne, New Jersey with 15 total locations, has been an industry leader in HVAC, climate control systems, plumbing and electrical supplies for more than 100 years. Through its subsidiaries and divisions, Universal Supply Group, RAL Supply Group, Inc., S&A Supply, Inc. and the Universal Energy Products Division, CCOM distributes equipment, parts, and accessories throughout the Northeast. The company’s reach extends from Albany, New York and Western Massachusetts (S&A Supply) down through the Hudson Valley, Westchester County, and Long Island (RAL Supply) and through all of New Jersey (Universal Supply Group). For additional information, visit https://ccom-group.com/.

 

This release includes forward-looking statements, including those regarding the timing and benefits of the transactions, the combined company’s plans and prospects, and other statements that are not historical facts. The forward-looking statements involve a number of risks, uncertainties and other factors that could cause actual results to differ materially from those contained in the forward-looking statements, some of which are beyond our control. Forward-looking statements speak only as of the date of this release and we disclaim any duty to update them except as required by law.

Contacts

Marc Bellanger

713.263.5505

marc.bellanger@daikincomfort.com

Wendy Hall

713.232.9229

wendy.hall@goodmanmfg.com

Angie Meyer

201.249.4874

ameyer@usginc.com

Categories
Business

Best’s Special Report: U.S. Life/Annuity Industry posts 61% net income spike in 2021

OLDWICK, N.J. — (BUSINESS WIRE) — The U.S. life/annuity (L/A) industry saw a 61% increase in net income to $36.2 billion in 2021 despite higher expenses and benefit payouts. These preliminary results are detailed in a new Best’s Special Report, titled, “First Look: 2021 Life/Annuity Financial Results,” and the data is derived from companies’ annual statutory statements received as of March 14, 2022, representing an estimated 93% of the total L/A industry’s net premiums written.

According to the report, total expenses for the industry grew 7.6%, as an additional $10.6 billion transferred to separate accounts minimized the increases in death, annuity and surrender benefits. Pretax net operating gain for the industry was $51.8 billion, up 38.2% over the prior year. A $3.3 billion increase in tax obligations and $2.7 billion reduction of net realized capital losses contributed to the higher net income result.

Capital and surplus rose 9.0% from the end of 2020 to $444.5 billion, as the net income result plus contributed capital, changes in unrealized gains and other changes in surplus were reduced by a $15.1 billion change in asset valuation reserve and $33.3 billion of stockholder dividends.

To access the full copy of this special report, please visit http://www3.ambest.com/bestweek/purchase.asp?record_code=318389.

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

Copyright © 2022 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Matthew Coppola
Director, Data Management
+1 908 439 2200, ext. 5627
matthew.coppola@ambest.com

Christopher Sharkey
Manager, Public Relations
+1 908 439 2200, ext. 5159
christopher.sharkey@ambest.com

Jim Peavy

Director, Communications

+1 908 439 2200, ext. 5644
james.peavy@ambest.com

Categories
Business

inTEST to host hybrid Investor & Analyst Day

MT. LAUREL, N.J.–(BUSINESS WIRE)–inTEST Corporation (NYSE American: INTT), a global supplier of innovative test and process solutions for use in manufacturing and testing in key target markets which include automotive, defense/aerospace, industrial, life sciences, security and semiconductor, today announced it will host its first Investor & Analyst Day on March 24, 2022 in a hybrid format from Philadelphia, PA. The event will begin at 9:00 a.m. ET with presentations followed by a question and answer session. The webcast portion will conclude at approximately 12:00 p.m. ET.

During the event, Nick Grant, President and Chief Executive Officer, Duncan Gilmour, Chief Financial Officer and other members of the inTEST management team will provide details of the Company’s progress with its 5-Point Strategy for growth.

Viewers will be able to submit questions via the webcast. Please sign into the webcast approximately 10 to 15 minutes prior to the event start time. The video webcast of the event with accompanying slides will be available at ir.intest.com. A replay as well as a copy of the slide presentation will be available following the event.

About inTEST Corporation

inTEST Corporation is a global supplier of innovative test and process solutions for use in manufacturing and testing in target markets which include automotive, defense/aerospace, industrial, life sciences, and security, as well as both the front-end and back-end of the semiconductor manufacturing industry. Backed by decades of engineering expertise and a culture of operational excellence, inTEST solves difficult thermal, mechanical, and electronic challenges for customers worldwide while generating strong cash flow and profits. inTEST’s strategy leverages these strengths to grow organically and with acquisitions through the addition of innovative technologies, deeper and broader geographic reach, and market expansion. For more information, visit www.intest.com.

Contacts

inTEST Corporation
Duncan Gilmour

Chief Financial Officer, Treasurer and Secretary

Tel: (856) 505-8999

Investors:
Deborah K. Pawlowski

Kei Advisors LLC

dpawlowski@keiadvisors.com
Tel: (716) 843-3908

Categories
Business

Legend Biotech reports fourth quarter and full year 2021 financial results and recent highlights

  • U.S. Food Drug Administration approved CARVYKTI(ciltacabtagene autoleucel; cilta-cel), a BCMA-directed CAR T-cell therapy for the treatment of adults with relapsed or refractory multiple myeloma (MM) who have received four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody
  • The CARTITUDE clinical development program is progressing to evaluate cilta-cel in patients with newly diagnosed MM across two randomized Phase 3 studies (CARTITUDE-5 and CARTITUDE-6)
  • Longer-term follow-up data for CARTITUDE-1 presented at 63rd American Society of Hematology Annual Meeting continued to show deep and durable responses
  • Legend Biotech appoints Marc L. Harrison as Vice President and General Counsel

SOMERSET, N.J. —  (BUSINESS WIRE) –Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies, today reported unaudited financial results for the fourth quarter of 2021.

“Legend Biotech ended the fourth quarter with strong data on our lead product candidate and nearly $900 million in cash,” said Ying Huang, PhD, Chief Executive Officer and Chief Financial Officer of Legend Biotech. “Both achievements put us in a strong position to commercialize CARVYKTI in 2022 and advance our pipeline.”

Dr. Huang added: “As we close another quarter, I continue to be impressed by our incredible teams around the world. Thanks to their dedication, our pipeline candidates have shown tremendous promise across multiple therapeutic areas, including gastric cancer. As I look to the year ahead, I am confident that Legend will continue its work of realizing the promise of CAR-T.”

Recent Highlights

  • The U.S. Food and Drug Administration (U.S. FDA) approved CARVYKTI™ (ciltacabtagene autoleucel) for the treatment of adults with relapsed or refractory multiple myeloma (MM) who have received four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
  • Legend Biotech and its collaboration partner Janssen Biotech, Inc. (Janssen) is progressing the CARTITUDE clinical development program in earlier lines across Phase 3 studies, including a collaborative study.
    • CARTITUDE-4 completed enrollment. The Phase 3, open-label study evaluates cilta-cel in patients with multiple myeloma who have received 1-3 prior lines of therapy, including a proteasome inhibitor and immunomodulatory agent and are refractory to lenalidomide. The purpose of this study is to compare the efficacy of cilta-cel with standard therapy – either pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd).
    • CARTITUDE-5 initiated enrollment. The Phase 3, randomized, open-label study compares bortezomib, lenalidomide and dexamethasone (VRd) induction followed by cilta-cel vs. VRd induction followed by lenalidomide and dexamethasone (Rd) maintenance in patients with newly diagnosed MM for whom autologous stem cell transplant (ASCT) is not planned as initial therapy (NCT04923893)
    • CARTITUDE-6 (not yet recruiting; sponsored by the European Myeloma Network). The Phase 3, randomized, open-label study compares daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) followed by cilta-cel vs. DVRd followed by autologous stem cell transplant (ASCT) in newly diagnosed patients with MM who are transplant eligible (NCT05257083)
  • New and updated results from the CARTITUDE clinical development program studying cilta-cel in various clinical settings were presented at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition in 2021. Two-year follow-up data for CARTITUDE-1 were presented showing continued deep and durable responses of cilta-cel in patients with heavily pretreated MM.
  • A New Drug Application for cilta-cel was submitted to the Ministry of Health, Labour and Welfare (MHLW) in Japan by Janssen in December 2021.
  • New, preclinical in vivo data on Legend Biotech’s novel tri-specific, single-domain antibody (VHH) CAR-T (LCAR-AIO) were presented at ASH 2021 as a poster (Abstract #1700). LCAR-AIO targets three antigens—CD19, CD20 and CD22.
  • Legend Biotech raised approximately $345 million in gross proceeds in a follow-on public offering of its American depositary shares (ADSs).
  • Marc L. Harrison was appointed Vice President and General Counsel of Legend Biotech in January 2022. Mr. Harrison brings more than 20 years of experience in healthcare and life sciences to the role. He previously served as Vice President, General Counsel and Head of Compliance at Breckenridge Pharmaceutical, Inc. and has held senior legal and leadership positions at Ipsen Biopharmaceuticals, Medco Health Solutions and WebMD.
  • A clinical hold was placed by the U.S. FDA in February 2022 on the Phase 1, open-label, multicenter clinical trial to evaluate LB1901, an investigational autologous CD4-targeted CAR-T therapy for the treatment of adults with relapsed or refractory peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL) (NCT04712864). Legend Biotech subsequently received an official clinical hold letter from the FDA dated March 1, 2022. In the letter, FDA stated that the reason for the hold is because the related IND does not contain sufficient information required by 21 CFR 312.23 to assess the risks to subjects.
  • Legend Biotech achieved two milestone payments amounting to $50 million, under the terms of its collaboration and license agreement with Janssen for the joint development and commercialization of cilta-cel.

Financial Results for the Quarter and Year Ended December 31, 2021

Cash Position

As of December 31, 2021, Legend Biotech had approximately $887.1 million of cash and cash equivalents, deposits and short-term investments.

Revenue

Revenue for the three months ended December 31, 2021 was $39.0 million compared to $40.8 million for the three months ended December 31, 2020. The decrease of $1.8 million was mainly due to the timing of when different milestones were achieved during those quarters.

Revenue for the year ended December 31, 2021 was $89.8 million, compared to $75.7 million for the year ended December 31, 2020. This increase of $14.1 million was primarily driven by revenue recognized from three additional milestones achieved in fiscal year 2021 and an exclusive licensing of certain patents to Nanjing Probio Biotech Co., Ltd and its affiliates during the year ended December 31, 2021. We have not generated any revenue from product sales to date.

Research and Development Expenses

Research and development expenses for the three months ended December 31, 2021 were $86.5 million compared to $66.9 million for the three months ended December 31, 2020. This increase of $19.6 million was primarily due to continuous research and development activities in cilta-cel and for other pipelines in 2021. Research and development expenses in 2021 were $313.3 million, compared to $232.2 million for the year ended December 31, 2020, an increase of $81.1 million.

Administrative Expenses

Administrative expenses for the three months ended December 31, 2021 were $17.1 million compared to $9.2 million for the three months ended December 31, 2020. The increase of $7.9 million was primarily due to Legend Biotech’s expansion of supporting administrative functions to facilitate continuous research and development activities as well as activities to establish elements of a commercialization infrastructure. Due to the consistent business expansion, administrative expenses for the year ended December 31, 2021 increased by $23.8 million, to $46.9 million, compared to $23.1 million for the year ended December 31, 2020.

Selling and Distribution Expenses

Selling and distribution expenses for the three months ended December 31, 2021 were $52.8 million compared to $24.2 million for the three months ended December 31, 2020. This increase of $28.6 million was primarily due to increased costs associated with commercial preparation activities for cilta-cel launch. Due to the consistent business expansion, selling and distribution expenses for the year ended December 31, 2021 increased by $52.9 million, to $102.5 million, compared to $49.6 million for the year ended December 31, 2020.

Other Income and Gains

Other income and gains for the three months ended December 31, 2021 was $0.7 million compared to $2.1 million for the three months ended December 31, 2020. The decrease of $1.4 million was primarily driven by a decrease in foreign exchange gain. Other income and gains for the year ended December 31, 2021 was $3.1 million compared to $6.1 million for the year ended December 31, 2020. The decrease of $3.0 million primarily resulted from less interest income from time deposits of lower average interest rate and less government grants.

Other Expenses

Other expenses for the three months ended December 31, 2021 was $2.2 million compared to $0.3 million for the three months ended December 31, 2020. The increase of $1.9 million was primarily due to higher foreign exchange loss. Other expenses for the year ended December 31, 2021 was $9.1 million compared to $0.3 million for the year ended December 31, 2020. The increase was primarily due to foreign exchange loss and loss from disposal of assets.

Finance Costs

Finance costs for the year ended December 31, 2021 was $0.9 million, mainly composed of interest for advance funding, which is interest-bearing borrowings funded by the collaborator and constituted by a principal and applicable interests upon such principal. Finance costs for the year ended December 31, 2020 was $4.2 million, resulted from the finance costs for the issuance of convertible redeemable preferred shares (Series A Preferred Shares) that were fully converted into ordinary shares upon the completion of Legend Biotech’s initial public offering in June 2020.

Fair Value Loss of Warrant Liability

Fair value loss of warrant liability for the year ended December 31, 2021 was $6.2 million caused by changes in the fair value of a warrant that we issued to an institutional investor through a private placement transaction in May 2021 with initial fair value of $81.7 million at the issuance date. The warrant was assessed as a financial liability with a fair value of $87.9 million as of December 31, 2021.

Fair Value Loss of Convertible Redeemable Preferred Shares

For the year ended December 31, 2020, Legend Biotech reported a one-time non-cash charge of $80.0 million caused by changes of the fair value of its Series A Preferred Shares. Upon Legend Biotech’s listing of its ADSs on the Nasdaq Global Market, all outstanding Series A Preferred Shares were automatically converted into ordinary shares of Legend Biotech and all accrued but unpaid dividends were settled in the form of ordinary shares of Legend Biotech. No such fair value loss in 2021 as the Company has no outstanding preferred shares after the listing.

Loss for the Period

Net loss for the three months ended December 31, 2021 was $88.3 million, or $0.30 per share, compared to $57.8 million, or $0.22 per share, for the three months ended December 31, 2020. Net loss for the year ended December 31, 2021 was $386.2 million, or $1.37 per share, compared to $303.5 million, or $1.28 per share, for the year ended December 31, 2020.

About Legend Biotech

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

Learn more at www.legendbiotech.com and follow us on Twitter and LinkedIn.

About CARVYKTI™ (Ciltacabtagene autoleucel; cilta-cel)

CARVYKTI™ is a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA. BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B-cells and plasma cells. The CARVYKTI™ CAR protein features two BCMA-targeting single domain antibodies designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.1

In December 2017, Legend Biotech Corporation entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel.

In April 2021, Legend announced the submission of a Marketing Authorisation Application to the European Medicines Agency seeking approval of cilta-cel for the treatment of patients with relapsed and/or refractory multiple myeloma. In addition to U.S. Breakthrough Therapy Designation granted in December 2019, cilta-cel received a Breakthrough Therapy Designation in China in August 2020. Cilta-cel also received Orphan Drug Designation from the U.S. FDA in February 2019, and from the European Commission in February 2020.

About the CARTITUDE-1 Study

CARTITUDE-1 (NCT03548207) is an ongoing Phase 1b/2, open-label, single arm, multi-center trial evaluating cilta-cel for the treatment of adult patients with relapsed or refractory multiple myeloma, who previously received at least three prior lines of therapy including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD) and an anti-CD38 monoclonal antibody. Of the 97 patients enrolled in the trial, 99 percent were refractory to the last line of treatment and 88 percent were triple-class refractory, meaning their cancer did not respond, or no longer responds, to an IMiD, a PI and an anti-CD38 monoclonal antibody.1

The longer-term efficacy and safety profile of cilta-cel is being assessed in the ongoing CARTITUDE-1 study, with two-year follow-up results recently presented at ASH 2021.2

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.3 In 2022, it is estimated that more than 34,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the U.S.4 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.5 Although treatment may result in remission, unfortunately, patients will most likely relapse.6 Patients who relapse after treatment with standard therapies, including protease inhibitors, immunomodulatory agents, and an anti-CD38 monoclonal antibody, have poor prognoses and few treatment options available.7,8

Cautionary Statement:

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech’s strategies and objectives; statements relating to CARVYKTI™, including Legend Biotech’s expectations for CARVYKTI™, such as Legend Biotech’s manufacturing and commercialization expectations for CARVYKTI™ and the potential effect of treatment with CARVYKTI™; statements about submissions for cilta-cel to, and the progress of such submissions with, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Chinese Center for Drug Evaluation of National Medical Products Administration (CDE) and other regulatory authorities; the anticipated timing of, and ability to progress, clinical trials, including patient enrollment; the submission of Investigational New Drug (IND) applications to, and maintenance of such applications with, regulatory authorities; the ability to generate, analyze and present data from clinical trials; and the potential benefits of Legend Biotech’s product candidates. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotech’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by our third party partners; uncertainties arising from challenges to Legend Biotech’s patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process; competition in general; government, industry, and general public pricing and other political pressures; the duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to the evolving situation; as well as the other factors discussed in the “Risk Factors” section of the Legend Biotech’s Annual Report filed with the Securities and Exchange Commission on April 2, 2021. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this press release as anticipated, believed, estimated or expected.​ Any forward-looking statements contained in this press release speak only as of the date of this press release. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

LEGEND BIOTECH CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF PROFIT OR LOSS

Three months ended

December 31

Year ended

December 31

(in thousands, US$, except share and per share data)

2021

2020

2021

2020

(Unaudited)

(Unaudited)

(Unaudited)

REVENUE

38,995

40,783

89,792

75,676

Other income and gains

743

2,079

3,059

6,119

Research and development expenses

(86,503

)

(66,934

)

(313,346

)

(232,160

)

Administrative expenses

(17,142

)

(9,171

)

(46,939

)

(23,147

)

Selling and distribution expenses

(52,811

)

(24,182

)

(102,542

)

(49,571

)

Other expenses

(2,214

)

(290

)

(9,132

)

(346

)

Fair value gain/(loss) of warrant liability..

31,200

(6,200

)

Fair value loss of convertible redeemable preferred

shares

(79,984

)

Finance costs

(602

)

(40

)

(900

)

(4,209

)

LOSS BEFORE TAX

(88,334

)

(57,755

)

(386,208

)

(307,622

)

Income tax (expense)/credit

(72

)

(1

)

4,145

LOSS FOR THE PERIOD

(88,334

)

(57,827

)

(386,209

)

(303,477

)

Attributable to:

Equity holders of the parent

(88,334

)

(57,827

)

(386,209

)

(303,477

)

Loss per share attributable to ordinary equity holders

of the parent:

Ordinary shares – basic

(0.30

)

(0.22

)

(1.37

)

(1.28

)

Ordinary shares – diluted

(0.30

)

(0.22

)

(1.37

)

(1.28

)

Shares used in loss per share computation:

Ordinary shares – basic

293,199,033

264,720,588

281,703,291

236,305,234

Ordinary shares – diluted

293,199,033

264,720,588

281,703,291

236,305,234

LEGEND BIOTECH CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

December 31, 2021

December 31, 2020

(in thousands, US$)

(Unaudited)

NON-CURRENT ASSETS

Property, plant and equipment

145,724

113,091

Advance payments for property, plant and equipment

2,168

224

Right-of-use assets

7,186

8,009

Other non-current assets

5,148

3,973

Intangible assets

4,684

2,852

Time deposits

4,705

Total non-current assets

169,615

128,149

CURRENT ASSETS

Inventories

1,749

1,800

Trade receivables

50,410

74,978

Prepayments, other receivables and other assets

12,754

10,007

Financial assets measured at amortized cost

29,937

Pledged deposits

1,444

384

Time deposits

163,520

50,000

Cash and cash equivalents

688,938

455,689

Total current assets

948,752

592,858

Total assets

1,118,367

721,007

CURRENT LIABILITIES

Trade and notes payables

7,043

5,238

Other payables and accruals

123,464

99,168

Government grants

304

283

Warrant liability

87,900

Lease liabilities

911

1,464

Contract liabilities

60,644

55,014

Total current liabilities

280,266

161,167

NON-CURRENT LIABILITIES

Contract liabilities

242,578

275,071

Lease liabilities

1,593

1,909

Interest-bearing loans and borrowings

120,462

(in thousands, US$)

December 31, 2021

December 31, 2020

(Unaudited)

Government grants

1,866

2,051

Other non-current liabilities

396

554

Total non-current liabilities

366,895

279,585

Total liabilities

647,161

440,752

EQUITY

Share capital

31

27

Reserves

471,175

280,228

Total equity

471,206

280,255

Total liabilities and equity

1,118,367

721,007

LEGEND BIOTECH CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

Three months ended

December 31

Year ended

December 31

(in thousands, US$)

2021

(Unaudited)

2020

(Unaudited)

2021

(Unaudited)

2020

LOSS BEFORE TAX

(88,334

)

(57,755

)

(386,208

)

(307,622

)

CASH FLOWS USED IN OPERATING ACTIVITIES

(69,547

)

(55,952

)

(198,465

)

(223,005

)

CASH FLOWS FROM/(USED IN) INVESTING

ACTIVITIES

96,512

61,165

(194,983

)

(24,169

)

CASH FLOWS FROM FINANCING

ACTIVITIES

323,561

661

626,663

618,879

NET INCREASE IN CASH AND CASH

EQUIVALENTS

350,526

5,874

233,215

371,705

Effect of foreign exchange rate changes, net

78

434

34

620

Cash and cash equivalents at beginning of the

period

338,334

449,381

455,689

83,364

CASH AND CASH EQUIVALENTS AT END OF THE

PERIOD

688,938

455,689

688,938

455,689

ANALYSIS OF BALANCES OF CASH AND CASH

EQUIVALENTS

Cash and bank balances

858,607

506,073

858,607

506,073

Less: Pledged deposits

1,444

384

1,444

384

Time deposits

168,225

50,000

168,225

50,000

Cash and cash equivalents as stated in the

statement of financial position

688,938

455,689

688,938

455,689

Cash and cash equivalents as stated in the

statement of cash flows

688,938

455,689

688,938

455,689


1 CARVYKTI™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc.

2 Martin, T. Updated Results From CARTITUDE-1: Phase 1b/2 Study of Ciltacabtagene Autoleucel, a B-cell Maturation Antigen–Directed Chimeric Antigen Receptor T Cell Therapy, in Patients with Relapsed/Refractory Multiple Myeloma. Abstract #549 [Oral]. Presented at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition.

3 American Society of Clinical Oncology. Multiple myeloma: introduction.

Contacts

Investors:
Joanne Choi, Senior Manager of Investor Relations, Legend Biotech

joanne.choi@legendbiotech.com

Crystal Chen, Manager of Investor Relations, Legend Biotech

crystal.chen@legendbiotech.com

Press:
Tina Carter, Corporate Communications Lead, Legend Biotech

tina.carter@legendbiotech.com
(908) 331-5025

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