Cardinal Health Reports Third Quarter Fiscal 2022 Results

On May 5, 2022 Cardinal Health (NYSE: CAH) reported third quarter fiscal year 2022 revenues of $44.8 billion, an increase of 14% from the third quarter of last year (Press release, Cardinal Health, MAY 5, 2022, View Source [SID1234613666]). Third quarter GAAP operating loss was $97 million, due to a non-cash, pre-tax goodwill impairment of $474 million in the Medical segment. GAAP diluted loss per share was $5.05, primarily due to this impairment, net of tax effects. Third quarter non-GAAP operating earnings decreased 21% to $545 million, primarily due to inflationary impacts and global supply chain constraints in the Medical segment. Non-GAAP diluted earnings per share (EPS) decreased 5% to $1.45, reflecting the change in non-GAAP operating earnings, partially offset by a lower non-GAAP effective tax rate and share count.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, healthcare systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide. (PRNewsfoto/Cardinal Health)

"While we’re taking action to drive performance across all our businesses, particularly the Medical segment, our third quarter results reflect continued inflationary impacts and global supply chain constraints," said Mike Kaufmann, chief executive officer of Cardinal Health. "We have updated our outlook for Medical to reflect the challenging environment, and reiterated our outlook for the Pharmaceutical segment in fiscal year 2022. Going forward, we remain confident in our ability to drive sustainable, long-term growth."

Third-quarter revenue for the Pharmaceutical segment increased 17% to $41.0 billion, driven by branded pharmaceutical sales growth from existing and net new Pharmaceutical Distribution and Specialty customers.

Pharmaceutical segment profit decreased 5% to $487 million in the third quarter, driven by higher operations expenses and previously anticipated investments in technology enhancements, partially offset by generics program performance.

Medical segment

Third-quarter revenue for the Medical segment decreased 7% to $3.9 billion, due to the divestiture of the Cordis business and lower products and distribution volumes, which includes the impact of global supply chain constraints.

Medical segment profit decreased 66% to $59 million in the third quarter, primarily due to net inflationary impacts and global supply chain constraints in products and distribution.

Opioid lawsuits developments

Cardinal Health, along with pharmaceutical distribution peers, finalized the previously announced national opioid settlement agreement (the "National Settlement"), which became effective on April 2, 2022. 46 of 49 eligible states, Washington DC, all eligible territories, and greater than 98 percent of litigating political subdivisions are participating in the National Settlement. This comprehensive agreement will settle the vast majority of the opioid lawsuits filed by state and local governmental entities. Under the National Settlement, the Company will pay participating states and subdivisions up to $6.0 billion2, the majority of which will be paid over 18 years. The settlement also includes injunctive relief terms related to distributors’ controlled substance anti-diversion programs, which are designed in part to provide increased transparency within the supply chain. As part of the injunctive relief terms, the distributors will engage a third-party vendor to act as a clearinghouse for data aggregation and reporting. Additional injunctive relief provisions include terms related to the training of controlled substance monitoring program employees, due diligence for new and existing customers, ordering limits for certain products and suspicious order monitoring.

Additionally, in May 2022, Cardinal Health, along with pharmaceutical distribution peers, reached an agreement with the State of Washington to resolve the opioid-related claims of the state and its participating subdivisions. Under this agreement, we will pay up to approximately $160 million, which is consistent with the amount that would have been allocated to Washington under the National Settlement, plus certain attorneys’ fees and costs. The payments will be made on timelines and terms consistent with the National Settlement. This agreement is subject to certain contingencies, including the rate of subdivision participation.

"These settlements are an important step forward for our company," said Kaufmann. "This is a significant milestone towards achieving broad resolution of governmental opioid claims and delivering meaningful relief to communities across the United States."

Fiscal year 2022 outlook1

The company updated its fiscal year 2022 guidance range for non-GAAP diluted earnings per share attributable to Cardinal Health, Inc. to $5.15 to $5.25, from $5.15 to $5.50.

The company also updated Medical segment profit outlook to a forty-five to fifty-five percent decline, from a thirty to forty-five percent decline. The fiscal year 2022 outlook for Medical segment profit includes a year-over-year net incremental headwind of nearly $300 million due to inflationary and global supply chain constraint impacts.

In addition to the updated Medical segment profit outlook, the new non-GAAP EPS guidance range reflects updated expectations3 for fiscal year 2022 non-GAAP effective tax rate of 22% to 23%, diluted weighted average shares outstanding of approximately 281 million, and capital expenditures of approximately $400 million.

The company does not provide forward-looking guidance on a GAAP basis as certain financial information, the probable significance of which cannot be determined, is not available and cannot be reasonably estimated. See "Use of Non-GAAP Measures" following the attached schedules for additional explanation.

Tax rate

During the third quarters of fiscal 2022 and 2021, GAAP effective tax rates were (916.5%) and 72.8%, respectively. The GAAP effective tax rate for the third quarter of fiscal 2022 included the impact of non-cash, pre-tax goodwill impairments of $1.8 billion in the Medical segment in fiscal 2022, which significantly decreased the estimated annual effective tax rate for fiscal year 2022. Applying the lower tax rate to the year-to-date loss resulted in recognizing an interim tax expense in the quarter of approximately $1.2 billion. The GAAP effective tax rate in the third quarter of fiscal 2021 reflected the tax effect of the litigation charge incurred in the first quarter of fiscal 2021.

The third quarter fiscal 2022 and 2021 non-GAAP effective tax rates of 20.1% and 31.2%, respectively, reflect the impact of certain discrete items. Third quarter fiscal 2021 effective tax rates also reflect the resolution of all open issues with the IRS for fiscal years 2008 to 2010 as well as certain transfer pricing matters for fiscal years 2011 to 2014.

Recent highlights

Cardinal Health announced plans to build a new 574,670 square foot medical distribution center in the central Ohio area, replacing a smaller nearby facility. The new, larger building will improve service and quality, deliver operational efficiencies, and better support fluctuations in volume and labor.
Cardinal Health plans to build a new manufacturing facility dedicated to increasing the supply of Protexis brand gloves, driving further growth in the surgical glove portfolio.
Cardinal Health partnered with Innara Health, the industry leader in feeding development for newborns and premature infants, to design Innara’s next generation NTrainer System, making it smaller, more intuitive, and easier to integrate into NICU feeding protocols.
Cardinal Health launched the first surgical incise drape using Avery Dennison’s patented BeneHoldTM CHG adhesive, which reduces the risk of surgical site contamination, yet still removes easily after surgery without harming a patient’s skin.
Cardinal Health partnered with Kinaxis to optimize digital supply chain planning and increase supply chain agility and medical product visibility to patients, with initial implementation in at-Home Solutions. Kinaxis’s Rapid ResponseTM platform supports fast, confident decisions using advanced insights and analytics in real time.
Forbes named Cardinal Health one of America’s Best Large Employers 2022.
Upcoming webcasted investor events

UBS Global Healthcare Conference at 8:30 a.m. EST, May 25, 2022
Webcast

Cardinal Health will host a webcast today at 8:30 a.m. Eastern to discuss third-quarter results. To access the webcast and corresponding slide presentation, go to the Investor Relations page at ir.cardinalhealth.com. No access code is required.

Presentation slides and a webcast replay will be available until May 4, 2023.

Clovis Oncology to Present at the BofA Securities 2022 Healthcare Conference

On May 5, 2022 Clovis Oncology, Inc. (Nasdaq: CLVS) reported that its President and Chief Executive Officer, Patrick J. Mahaffy, will present at the BofA Securities 2022 Healthcare Conference on Wednesday, May 11, 2022, at 10:00 a.m. Pacific time (Press release, Clovis Oncology, MAY 5, 2022, View Source [SID1234613682]). The conference will be held at the Encore hotel in Las Vegas.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the presentation can be accessed through the investor relations section of the Company’s website at www.clovisoncology.com. Following the live presentation, a replay of the webcast will be available on the Company’s website for 30 days.

EDAP to Showcase its Focal One® Platform at the Annual Meeting of the American Urological Association (AUA)

On May 5, 2022 EDAP TMS SA (Nasdaq: EDAP) ("the Company"), the global leader in robotic energy-based therapies, reported that the company will be showcasing and exhibiting its Focal One Robotic High Intensity Focused Ultrasound (HIFU) platform at the upcoming Annual Meeting of the American Urological Association (AUA), the largest gathering of urologists worldwide, which will be held May 13th through 15th in New Orleans (Press release, EDAP TMS, MAY 5, 2022, View Source [SID1234613698]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Focal One will be a featured topic at AUA, during both plenary presentations and instructional courses. Several notable presentations will be given by leading academic centers describing the growing clinical acceptance of the role of focal therapy in the management of prostate cancer. An AUA hands-on skills training will be teaching urologists how to implement focal treatments in their practice and will allow them to utilize Focal One under the guidance of expert faculty.

Ryan Rhodes, CEO of EDAP U.S., said, "We are very pleased to have such a notable presence at AUA, the most high-profile urology meeting of the year. Focal therapy is quickly becoming a necessary prostate cancer treatment option, and we are pleased that many highly regarded healthcare institutions will be on hand to describe their experience to date. We believe Focal One is the most advanced focal therapy platform available today, and we look forward to demonstrating this cutting-edge technology to the many urology thought leaders who will be in attendance."

Ongoing Focal One and ExactVu Micro-Ultrasound hands-on simulations will be provided to urologists at the EDAP Focal One booth (#117) throughout the meeting. ExactVu will be featured in two skill-enhancement workshops about the scientific evidence of microultrasound and the flexibility for transperineal or transrectal approaches.

Twist Bioscience Reports Second Quarter 2022 Financial Results

On May 5, 2022 -Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported financial results and business highlights for the second quarter of fiscal 2022 ended March 31, 2022 (Press release, Twist Bioscience, MAY 5, 2022, View Source [SID1234613713]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We’re building momentum through the first half of fiscal 2022, with another consecutive quarter of record revenue and orders," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "We continued to deliver a wide range of products to our customers through the Omicron surge, while bolstering our balance sheet to reduce downside risk in this unpredictable market."

"Twist Biopharma added 5 new partnerships and 15 programs, with Twist Boston (Abveris) actively working on 81 programs today. For data storage, we are building important relationships with key industry associations and are debugging our integrated CMOS chip for production capacity now, both critical for the introduction of our storage solutions," continued Dr. Leproust.

"We remain committed to managing our cash burn in our drive toward adjusted EBITDA break even for the core business, which we expect to occur when we reach $300 million in revenue for SynBio and NGS," added Jim Thorburn, CFO of Twist.

FISCAL 2022 SECOND QUARTER FINANCIAL RESULTS

Orders: Total orders received for the second quarter of fiscal 2022 were $55.0 million compared to $41.7 million for the same period of fiscal 2021.
Revenue: Total revenues for the second quarter of fiscal 2022 were $48.1 million compared to $31.2 million for the same period of fiscal 2021.
Cost of Revenues: Cost of revenues for the second quarter of fiscal 2022 was $29.7 million compared to $19.0 million for the same period of fiscal 2021.
Research and Development Expenses: Research and development expenses for the second quarter of fiscal 2022 were $31.2 million compared to $15.8 million for the same period of fiscal 2021.
Selling, General and Administrative Expenses: Selling, general and administrative expenses for the second quarter of fiscal 2022 were $54.0 million compared to $34.4 million for the same period of fiscal 2021.
Net Loss: Net loss attributable to common stockholders for the second quarter of fiscal 2022 was $60.7 million, or $1.13 per share, compared to $37.9 million, or $0.78 per share, for the same period of fiscal 2021.
Cash Position: As of March 31, 2022, the company had $604.4 million in cash, cash equivalents and investments.
Recent Highlights:

SynBio and NGS

Shipped products to approximately 2,000 customers in the second quarter of fiscal 2022, versus approximately 1,700 in the second quarter of fiscal 2021.
Shipped approximately 124,000 genes during the second quarter of fiscal 2022, compared with approximately 90,000 in the second quarter of fiscal 2021.
Entered into four-year supply agreement with Ginkgo Bioworks, which includes a $58 million minimum in all product purchases over the lifetime of the contract with Ginkgo having the option to access significantly more products from Twist.
Launched Twist High Throughput Antibody Production, a gene-to-antibody production platform that enables customers to turn digital DNA sequences into purified IgG antibodies for therapeutic discovery and screening applications.
Launched encapsulated synthetic RNA positive controls for SARS-CoV-2 that can be shipped and stored at room temperature to enable Twist to serve customers in regions that do not have an effective cold chain system or easy access to ultra-cold storage and may also allow the use of the controls in point of care settings.
Partnered with C2i Genomics to develop whole-genome cancer reference materials to be used to provide diagnostic labs with the ability to better validate and monitor the quality of whole-genome cancer screening and minimal residual disease (MRD) products.
Created a replicon tool with Eleven Therapeutics to be used to study viral genome replication and antiviral drug screening for SARS-CoV-2 as well as vaccine and therapeutic development.
BioPharma and DNA Data Storage

Signed an agreement with Kriya to discover and optimize novel antibodies to be used with Kriya’s gene therapy technology platform in oncology applications.
Signed a collaboration with MediSix Therapeutics to discover novel antibodies to be developed as T-cell therapies.
Announced that the DNA Data Storage Alliance, of which Twist is a founding member, has grown to more than 50 members.
Joined the Storage Networking Industry Association (SNIA) as a voting member.
Became a part of the Digital Preservation Coalition’s (DPC) Supporter Program.
Corporate

Raised $269.8 million in net proceeds in an upsized underwritten public offering of common stock.
Updated Fiscal 2022 Financial Guidance

The following statements are based on Twist’s current expectations for fiscal 2022. The following statements are forward-looking, and actual results could differ materially depending on market conditions and the factors set forth under "Forward-Looking Statements" below.

For the full fiscal year 2022, Twist provided the following updated financial guidance:

Revenue is now expected to be in the range of $191 million – $199 million
SynBio revenue including Ginkgo Bioworks is expected to be in the range of $71 million to $73 million
NGS revenue is estimated to be in the range of $94 million to $96 million
Biopharma revenue is estimated to be approximately $26 million to $30 million
Gross margin is expected to be 37% for fiscal 2022 which reflects the impact of expected costs associated with ramping our Wilsonville, Oregon "Factory of the Future" facility to bring it online; excluding these expected costs, gross margin would be 42% to 44%
Operating expenses including R&D and SG&A are expected to be approximately $335 million for the year
Net loss is expected to be approximately $260 to $265 million, reflecting the impact of the Abveris acquisition in stock-based compensation and includes:
R&D is expected to be approximately $130 million
Approximately $40 million for DNA data storage
Stock-based compensation is expected to be approximately $85 million
Depreciation is expected to be $13 million
Capital expenditures are expected to be $90-$100 million, including building out the "Factory of the Future"
Conference Call Information

The company plans to hold a conference call and live audio webcast for analysts and investors at 4:30 p.m. Eastern Time today to discuss its financial results and provide an update on the company’s business. The call can be accessed by dialing (866) 688-0947 (domestic) or (409) 217-8781 (international) and refer to the conference ID 7377195. A telephonic replay of the conference call will be available beginning approximately four hours after the call through May 12, 2022 and may be accessed by dialing (855) 859-2056 (domestic) or (404) 537-3406 (international). The replay conference ID is 7377195. The webcast replay will be available for two weeks. If a participant will be listen-only, they are encouraged to listen via the webcast on Twist’s investor page.

Abelacimab: First Factor XI Inhibitor to Enroll Patients in a Phase 3 Clinical Trial

On May 5, 2022 Anthos Therapeutics, a clinical-stage biopharma company developing innovative therapies for cardiovascular and metabolic diseases, reported that the first patient had been enrolled in a phase 3 clinical trial investigating a Factor XI agent (Press release, Anthos Therapeutics, MAY 5, 2022, View Source [SID1234613730]). The ASTER study is one of two complementary, international, multicenter trials where abelacimab is being studied in patients with Cancer Associated Thrombosis (CAT). In the ASTER trial, Anthos’ novel dual-acting Factor XI monoclonal antibody, abelacimab, is being compared to apixaban, the leading Factor Xa inhibitor, to assess their effects on venous thromboembolism (VTE) recurrence and bleeding in patients with cancer associated VTE.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Encouraged by evidence from a recently completed positive phase 2 study,1 we believe abelacimab could become an important new treatment option for the treatment and prevention of thrombosis in a variety of patients, including those with Cancer Associated Thrombosis. Abelacimab’s novel dual inhibitory activity offers the potential to provide effective antithrombotic activity with a reduced risk of bleeding compared to existing therapies. Additionally, the monthly dosing of abelacimab could reduce the burden of a daily regimen, such as daily injections or pills, for patients already receiving multiple therapies including chemotherapy," said Gary E. Raskob, Ph.D., Interim Senior Vice President, and Provost at the University of Oklahoma Health Sciences Center and the Chair of the Abelacimab CAT Program Steering Committee.

Venous Thromboembolism (VTE), which includes both deep vein thrombosis and pulmonary embolism, is the second most prevalent cause of death in patients with cancer, second only to the disease itself.2 However, treatment of CAT can be challenging because the currently available anticoagulants used to treat VTE can have an increased risk of bleeding.3,4

"An acute episode of thrombosis in patients with cancer adds additional complexity to the treatment of cancer itself and is a grave concern for physicians, patients, and caregivers. Our extensive phase 3 program for abelacimab includes two trials specifically designed for patients with Cancer Associated Thrombosis, including those with a particularly high risk of bleeding. Enrolling the first patients in the ASTER phase 3 trial is an important first step toward making an effective and potentially safer anticoagulant available to patients with cancer. This phase 3 program is in addition to our ongoing phase 2 AZALEA-TIMI 71 trial comparing abelacimab to rivaroxaban in atrial fibrillation (AF), which completed enrollment with 1,287 patients in December 2021. This study, the largest trial to date with a Factor XI inhibitor, will compare bleeding rates in AF patients treated with abelacimab and rivaroxaban," said Dan Bloomfield, M.D., Chief Medical Officer, Anthos Therapeutics.

About Abelacimab
Abelacimab is a novel, highly selective, fully human monoclonal antibody designed to induce effective hemostasis-sparing anticoagulation through Factor XI inhibition. Abelacimab targets the active domain of Factor XI, demonstrating dual inhibitory activity against both Factor XI and its activated form, Factor XIa. Abelacimab can be administered intravenously (IV) to achieve rapid inhibition of Factor XI activity and then used subcutaneously (SC) monthly to maintain nearly complete inhibition in a chronic setting. In a PK/PD study, abelacimab administered IV provided profound suppression of Factor XI within one hour after the start of therapy and maintained near maximal inhibition for up to 30 days. 1,5 In a Phase 2 study whose results were published in the New England Journal of Medicine in 2021, a single intravenous dose of abelacimab after knee surgery reduced the rate of venous thromboembolism by 80%, measured 10 days after surgery, compared to enoxaparin.1 Factor XI inhibition offers the promise of hemostasis-sparing anticoagulation for the prevention and treatment of arterial and venous thromboembolic events.6 Abelacimab is an investigational agent and has not been approved for any indication.

About the Abelacimab Phase 3 Program in Cancer Associated Thrombosis (CAT)
The abelacimab phase 3 CAT program comprises two complementary studies targeting to enroll approximately 2700 patients across 220 sites in more than 20 countries — the largest program of any anticoagulant performed in Cancer-Associated Thrombosis.

ASTER is an international multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE) recurrence and bleeding in patients with cancer associated VTE in whom DOAC treatment is recommended. Abelacimab 150 mg will be administered intravenously (IV) on Day 1 and subcutaneously (SC) monthly thereafter for up to 6 months; Apixaban 10 mg will be administered orally, twice daily (bid) for the first 7 days, followed by 5 mg bid up to 6 months.

MAGNOLIA is an international multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study in patients with gastrointestinal (GI) / genitourinary (GU) cancer in whom DOAC treatment is not recommended. The study will compare the effect of abelacimab relative to dalteparin on VTE recurrence and bleeding in patients with cancer associated VTE who are at a high bleeding risk with non-resectable, locally or regionally invasive GI / GU tumors. Abelacimab 150 mg will be administered intravenously (IV) on Day 1 and subcutaneously (SC) monthly thereafter for up to 6 months; dalteparin administered subcutaneously will be given daily, 200 IU/kg/day for the first month, and then 150 IU/kg/day up to 6 months.

About the AZALEA-TIMI 71 Phase 2 Trial
The AZALEA-TIMI 71 trial is an event-driven, randomized, active-controlled, blinded endpoint, parallel-group study to evaluate the effect of two blinded doses of abelacimab relative to open label rivaroxaban on the rate of major or clinically relevant non-major (CRNM) bleeding events in patients with atrial fibrillation (AF) who are at moderate-to-high risk of stroke. The trial completed enrollment in December 2021, with 1287 patients across 95 global study sites including the U.S., Canada, as well as from parts of Europe, and Asia.

Verhamme P et al. New Engl J Med July 2021 (View Source)
Fernandes CJ et al. Eur. Resp. Rev. 2019 (View Source)
Agnelli G et al. New Engl J Med April 2020 (View Source)
Abdol Razak NB et al. Cancers (Basel) Oct. 2018 (View Source)
Yi BA et al. J Thromb Haemost. Oct. 2021 (View Source)
Hsu et al. J Am Coll Cardiol. Aug. 2021 (https://www.sciencedirect.com/science/article/abs/pii/S0735109721053213?via%3Dihub)