Medical Device Investing News

System delivers new capabilities for life science research and biotherapeutic development through novel ion fragmentation and increased sensitivity

SCIEX , a global leader in life science analytical technologies, presents the ZenoTOF 7600 system , a new accurate mass LC-MS/MS instrument. The new system enables scientists to identify, characterize and quantify molecules better than ever before by generating data that has been previously unattainable. This breakthrough will solve real analytical challenges and help advance the development of new precision diagnostics and biotherapeutics.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210617005207/en/

SCIEX presents new accurate mass instrument - the ZenoTOF 7600 system. This system delivers new capabilities for life science research and biotherapeutic development through novel ion fragmentation and increased sensitivity. (Photo: Business Wire)

SCIEX presents new accurate mass instrument - the ZenoTOF 7600 system. This system delivers new capabilities for life science research and biotherapeutic development through novel ion fragmentation and increased sensitivity. (Photo: Business Wire)

"Only a step-change in innovation will meet the evermore ambitious goals of scientists around the world. This new platform and mindset in accurate mass has the power to change people's perspective and profoundly impact lives."
- Joe Fox, President of SCIEX.

The ZenoTOF 7600 system includes the proprietary Zeno trap and electron activated dissociation (EAD) fragmentation for the first time in a commercial instrument. Zeno trap pulsing overcomes the traditional duty cycle challenges of orthogonal TOF technology, delivering up to 20x the sensitivity and enabling the routine detection of important low-abundant molecules. In combination, tunable EAD fragmentation ensures novel structural information can be extracted and quantified from diverse compound types – a capability that is not possible by using high resolution alone.

"The fact that we can now add alternative fragmentation to our existing workflows, and with higher sensitivity at the same time is really extraordinary. It's a real change in how data are generated and the biological insight we can get."
- Matt Champion, Associate Professor, University of Notre Dame.

Extraordinary sensitivity in combination with EAD fragmentation will push new boundaries in biomarker discovery and biopharmaceutical therapies

To advance the detection and treatment of disease, it is critical to understand how thousands of proteins, lipids and metabolites in the body are regulated and modified. Biomarkers, the molecules that change when we are ill, are used by doctors as the "canary in the coal mine" warning system. So far, scientists have only scratched the surface in biomarker discovery. The ZenoTOF 7600 system will help scientists uncover more and better biomarkers, bringing us closer to true precision medicine where the right drug is given to the right patient at the right time.

Compared to previous systems, the ZenoTOF 7600 system can quantify up to 40% more proteins and analyze samples 5x faster for large biobank studies. In addition, EAD fragmentation brings new capabilities to understand how the proteins are post-translationally modified – an important but challenging area in biomarker research.

"The ability to exactly tailor kinetic energy for EAD optimizes the MS/MS spectra and maximizes quantification accuracy. The use of Zeno trap pulsing provides significant gains in sensitivity, further improving the utility of this approach for characterizing PTMs."
- Birgit Schilling, PhD, Associate Professor, Director of the Mass Spectrometry Center, The Buck Institute

The ZenoTOF 7600 system is transformational for lipidomics and can fully characterize an individual lipid from a single spectrum using EAD fragmentation. This will enable the discovery of novel lipid markers for cancer and inflammatory disease, precisely identifying and quantifying individual species that has been previously impossible.

"We were never able to characterize all the way down to the double bond position of lipid species, or identify the exact position of side chains. I see the ZenoTOF 7600 system as a really important advancement in being able to completely profile the lipidome from the top to the bottom."
- James Cox, Research Associate Professor, University of Utah.

To bring life-saving next-generation biopharmaceutical therapies to market quickly and safely , critical quality attributes must be rapidly and comprehensively analyzed. For the first time, EAD fragmentation allows biopharmaceutical scientists to precisely detect and quantify protein glycosylation patterns and differentiate isomeric amino acids. Both are critical to ensuring that therapies are safe and do not produce adverse reactions.

"As biopharma scientists seek to develop more complex and sophisticated biotherapeutics, the challenge of analytics also becomes more complex. The ability of EAD to routinely and precisely characterize these biologics will change the game and make therapies accessible to patients much faster."
- Mani Krishnan, VP GM, CE & Biopharma at SCIEX

To learn more about the ZenoTOF 7600 system, visit here .

About SCIEX

SCIEX delivers solutions for the precision detection and quantification of molecules, empowering our customers to protect and advance the wellness and safety of all. We have led the field of mass spectrometry for 50 years. From the launch of the first ever commercially successful triple quadrupole in 1981, we have developed groundbreaking technologies and solutions that influence life-changing research and outcomes.

Today, as part of the Danaher (NYSE: DHR) family of global life science and technology innovators, we continue to pioneer robust solutions in mass spectrometry and capillary electrophoresis. Our customers are able to quickly respond to environmental hazards, better understand biomarkers relevant to disease, improve patient care in the clinic, bring relevant drugs to market faster and keep food healthier and safer.

That's why thousands of life science experts around the world choose SCIEX to get the answers they can trust to better inform critical decisions that positively impact lives.

For more information, visit sciex.com .

Let's connect: Twitter , LinkedIn , Facebook , and Instagram .

Advances in human wellness depend on the power of precise science.

The SCIEX clinical diagnostic portfolio is For In Vitro Diagnostic Use. Rx Only. Product(s) not available in all countries. For information on availability, please contact your local sales representative or refer to www.sciex.com/diagnostics . All other products are For Research Use Only. Not for use in Diagnostic Procedures.

Trademarks and/or registered trademarks mentioned herein, including associated logos, are the property of AB Sciex Pte. Ltd. or their respective owners in the United States and/or certain other countries (see www.sciex.com/trademarks ).

© 2021 DH Tech. Dev. Pte. Ltd. RUO-MKT-12-13460-A.

Lulu VanZandt
Manager, Brand, Public Relations and Social Media, SCIEX
lulu.vanzandt@sciex.com
+1 (508) 383-7163
M: +1 (508) 782-9484

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Medical Device Stocks: 5 Biggest Companies in 2022

Medical Device Stocks: 5 Biggest Companies in 2022

The top medical device companies are a vital component of the overarching life science industry, as well as a major force in treating many diseases and conditions.

The global medical device market was valued at US$434.2 billion in 2021, and is expected to grow at a compound annual growth rate of 6.3 percent to reach US$625.3 billion in 2027.

Growth in the global medical device industry is tied to the rapid rise of an aging population, increased infectious and chronic diseases, as well as technological advancements in both the field of life science and in emerging technologies such as 3D printing, robotics and the internet of things.

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New Study Shows Abbott's Blood Test for Concussion Could Predict Outcomes from Brain Injury and Inform Treatment Interventions

  • The study concluded that elevated levels of two proteins help predict how a person will recover from a traumatic brain injury (TBI), providing important information to determine appropriate care
  • Researchers used Abbott's i-STATâ„¢ TBI Plasma test – the only FDA-cleared rapid test on a portable analyzer for concussion – and Abbott's core laboratory ARCHITECT instrument to measure two biomarkers in blood plasma associated with brain injury

A new study published in The Lancet Neurology demonstrates the ability of two blood-based biomarkers to predict how someone will recover from traumatic brain injury (TBI). Testing for these two biomarkers in the immediate aftermath of an injury can help health care providers determine the best way to treat and care for patients.

This research shows that when a clinician conducts a blood test for these brain proteins soon after a possible injury, they quickly get a more accurate picture of how severe the injury is, the expected course of recovery and the longer-term implications of the TBI. The markers were measured using Abbott's i-STATâ„¢ TBI Plasma test , as well as on the company's ARCHITECT core laboratory instrument using research prototype assays, both of which helped predict recovery.

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Knight Therapeutics Reports Second Quarter 2022 Results

-- Achieves Record Quarterly Revenues and EBITDA 1 --

Knight Therapeutics Inc. (TSX: GUD) ("Knight" or "the Company"), a leading pan-American (ex-US) specialty pharmaceutical company, today reported financial results for its second quarter ended June 30, 2022. All currency amounts are in thousands except for share and per share amounts. All currencies are Canadian unless otherwise specified.

Q2 2022 Highlights

Financials

  • Revenues were $75,820, an increase of $10,024 or 15% over the same period in prior year.
  • Gross margin of $38,295 or 51% compared to $28,871 or 44% in the same period in prior year.
  • Adjusted EBITDA 1 was $17,890, an increase of $8,494 or 90% over the same period in prior year.
  • Net loss on financial assets measured at fair value through profit or loss of $7,692.
  • Net income was $2,516, compared to net income of $29,004 in the same period in prior year.
  • Cash inflow from operations was $11,521, compared to a cash inflow from operations of $12,409 in the same period in prior year.

Corporate Developments

  • Purchased 1,460,684 common shares through Knight's normal course issuer bid ("NCIB") at an average price of $5.30 for an aggregate cash consideration of $7,739.
  • Shareholders re-elected Jonathan Ross Goodman, Samira Sakhia, James C. Gale, Robert N. Lande, Michael J. Tremblay, Nicolás Sujoy and Janice Murray on the Board of Directors.

Products

  • Entered into an exclusive license, distribution and supply agreement with Helsinn Healthcare SA ("Helsinn") for AKYNZEO® oral/IV (netupitant/palonosetron/fosnetupitant/palonosetron) in Canada, Brazil and select LATAM countries and ALOXI® oral/IV (palonosetron) in Canada.
  • Entered into exclusive license and supply agreements with Rigel Pharmaceuticals ("Rigel") to commercialize fostamatinib in LATAM.
  • Obtained marketing authorization transfer of Exelon® from Novartis to Knight in Colombia, Brazil, and Mexico, and transferred Exelon®'s commercial activities from Novartis to Knight's affiliate in Colombia.

Subsequent Events

  • Relaunched AKYNZEO® in Brazil in July 2022.
  • Transferred marketing authorization of Exelon® from Novartis to Knight's affiliate in Chile.
  • Executed a settlement agreement with former controlling shareholders of GBT and will receive US$4.6 million.
  • Launched a NCIB in July 2022 to purchase up to 7,988,986 common shares of the Company over the next 12 months.

"I am excited to announce that Knight achieved record quarterly revenues this quarter and see continuous growth in each of our key therapeutic categories primarily driven by the lifting of COVID-19 restrictions as well as the impact of the acquisition of Exelon®. Almost one year after closing that transaction, we have completed the Exelon® marketing authorization transfers to Knight in our key LATAM territories and have assumed Exelon® commercial activities in Colombia. We also continued to execute on the business development front and entered into exclusive license, distribution and supply agreements with Helsinn and Rigel in our key territories,", said Samira Sakhia, President and Chief Executive Officer of Knight Therapeutics Inc.

__________
1 EBITDA and Adjusted EBITDA are a non-GAAP measures, refer to section "Non-GAAP measures" and "Reconciliation to adjusted EBITDA" for additional details


SELECT FINANCIAL RESULTS
[In thousands of Canadian dollars]

Change Change
Q2-22 Q2-21 $ 1 % 2 YTD-22 YTD-21 $ 1 % 2
Revenues 75,820 65,796 10,024 15% 139,627 111,865 27,762 25%
Gross margin 38,295 28,871 9,424 33% 70,772 49,451 21,321 43%
Gross margin % 51 % 44% 51% 44%
Operating expenses 4 35,959 28,855 7,104 25% 68,752 51,670 17,082 33%
Net income (loss) 2,516 29,004 (26,488 ) 91% (16,295 ) 32,562 (48,857 ) 150%
EBITDA 3 17,890 9,271 8,619 93% 31,202 14,431 16,771 116%
Adjusted EBITDA 3 17,890 9,396 8,494 90% 31,202 14,975 16,227 108%
  1. A positive variance represents a positive impact to net income (loss) and a negative variance represents a negative impact to net income (loss)
  2. Percentage change is presented in absolute values
  3. EBITDA and adjusted EBITDA are non-GAAP measures, refer to the definitions in section "Non-GAAP measures" for additional details
  4. Operating expenses include selling and marketing expenses, general and administrative expenses, research and development expenses, amortization and impairment of intangible assets


SELECT BALANCE SHEET ITEMS
[In thousands of Canadian dollars]

Change
06-30-22 12-31-21 $ % 1
Cash, cash equivalents and marketable securities 136,235 149,502 (13,267 ) 9 %
Trade and other receivables 131,570 103,875 27,695 27 %
Inventory 76,400 72,397 4,003 6 %
Financial assets 162,306 192,443 (30,137 ) 16 %
Accounts payable and accrued liabilities 82,635 65,590 17,045 26 %
Bank loans 32,483 35,927 (3,444 ) 10 %
  1. Percentage change is presented in absolute values

Revenues: For the quarter ended June 30, 2022 revenues increased by $10,024 or 15% compared to the same period in prior year. The growth in revenues excluding the impact of hyperinflation was $9,836 or 15% and is explained by the following:

  • Knight recognized revenues of $12,390 for Exelon®, an increase of $8,202 or 200% driven by the following factors:
    • The timing of the acquisition of Exelon® executed on May 26, 2021
    • Estimated increase in revenues between $4,000 to $4,500 driven by the purchasing pattern of certain customers as well as higher sales in Brazil in anticipation of the transfer of commercial activities from Novartis to Knight
  • An increase in revenues of $1,634 driven by the growth of recently launched products including the Q1-22 launches of Lenvima®, Rembre® and Halaven® in Colombia, an increase in patient treatments as our markets reduce COVID-19 restrictions and buying patterns offset by a decrease in revenues of certain of our oncology branded generics products due to market entrance of new competitors. In addition, revenues decreased by approximately $4,500 to $6,000 due to lower demand of certain of our infectious diseases products associated with COVID-19.

Gross margin: For the quarter ended June 30, 2022, gross margin increased from 44% to 51% explained by a change in product mix as well as the acquisition of Exelon®. The revenues of Exelon® is recorded as a net profit transfer from Novartis with the exception of revenues generated in Colombia upon the transfer of commercial activities to Knight in June 2022. The gross margin would have been 54% versus 51% (YTD-21: 44% to 46%) after excluding the adjustment of hyperinflation accounting in accordance with IAS 29.

Knight expects gross margin as a % of revenues to decline over the next quarters as the commercial activities of Exelon® are transferred to Knight on a country-by-country basis and the Company records revenues with related cost of sales instead of a net profit transfer.

Selling and marketing: For the quarter ended June 30, 2022, S&M expenses were $10,926, an increase of $1,742 or 19%, compared to the same period in prior year due to an increase in compensation expenses, certain variable costs such as logistics fees as well as an increase in selling and marketing activities related to key promoted products and Exelon®.

General and administrative: For the quarter ended June 30, 2022, G&A expenses were $10,566, an increased of $1,115 or 12%, compared to the same period in prior year due to an increase in compensation expense, certain consulting and professional fees partially offset by the lower costs of related to stock options

Research and development: For the quarter ended June 30, 2022, R&D expenses were $3,412, an increase of $827 or 32%, compared to the same period in prior year. The variance is not significant.

Amortization of intangible assets: For the quarter ended June 30, 2022, amortization of intangible assets was $11,055, an increase of $3,420 or 45%, compared to the same period in prior year driven by acquisition of Exelon®.

Interest income: Interest income is the sum of interest income on financial instruments measured at amortized cost and other interest income. For the quarter ended June 30, 2022, interest income was $2,427, an increase of 36% or $641, compared to the same period in prior year due to higher interest rates.

Interest expense: For the quarter ended June 30, 2022, interest expense was $1,717, an increase of $1,049 or 157%, compared to the same period in prior year due to higher interest rates partially offset by a lower average bank loan balance.

Adjusted EBITDA: For the quarter ended June 30, 2022, adjusted EBITDA increased by $8,494 or 90%. The growth in adjusted EBITDA is driven by an increase in gross margin of $9,424, offset by an increase in operating expenses.

Net loss or income: For the quarter ended June 30, 2022, net income was $2,516 compared to net income of $29,004 for the same period in prior year. The variance mainly resulted from the above-mentioned items and (1) a net loss on the revaluation of financial assets measured at fair value through profit or loss of $7,692 versus a net gain of $28,472 in the same period in prior year, mainly due to unrealized revaluations of the strategic fund investments, offset by (2) a foreign exchange gain of $4,507 mainly due to the unrealized gains on intercompany balances driven by the appreciation of the USD compared to a foreign exchange loss of $3,194 in the same period in prior year mainly due to depreciation of the USD.

Cash, cash equivalents and marketable securities : As at June 30, 2022, Knight had $136,235 in cash, cash equivalents and marketable securities, a decrease of $13,267 or 9% as compared to December 31, 2021. The variance is primarily due to outflows related to due to upfront payments and certain milestones mainly related to in-licensing of AKYNZEO® and ALOXI® from Helsinn as well as fostamatinib from Rigel, shares repurchased through NCIB, partially offset by cash inflows from operating activities.

Financial assets: As at June 30, 2022, financial assets were at $162,306, a decrease of $30,137 or 16%, as compared to the prior year, mainly due to negative mark-to-market adjustments of $23,520 driven by the decline in the share prices of the publicly-traded equities of our strategic fund investments due to general market conditions and distributions of $4,336. Given the nature of the fund investments there could be significant fluctuations in the fair value of the underlying assets.

Bank Loans: As at June 30, 2022, bank loans were at $32,483, a decrease of $3,444 or 10% as compared to the prior period, due to loan repayments of $5,391, partially offset by the appreciation of BRL and accrued interest.

Product Updates

The marketing authorizations of Exelon® for Colombia, Mexico, Chile and Brazil were transferred to Knight. The Company expects that remaining marketing authorizations will be transferred in the second half of 2022. Furthermore, Knight has assumed the commercial activities of Exelon® in Colombia and expects to assume commercial activities in Brazil, Mexico and Chile in Q3-22.

Knight entered into an exclusive license, distribution and supply agreement with Helsinn for AKYNZEO® oral/IV (netupitant/palonosetron / fosnetupitant/palonosetron) in Canada, Brazil and select LATAM countries and ALOXI® oral/IV (palonosetron) in Canada. AKYNZEO ® oral is approved and marketed in Canada for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy and the prevention of acute nausea and vomiting associated with moderately emetogenic cancer therapy that is uncontrolled by a 5-HT3 receptor antagonist alone in adults. AKYNZEO ® oral is also approved and marketed in Argentina and Brazil for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults. ALOXI® solution for injection is approved and marketed in Canada for the prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy and highly emetogenic cancer chemotherapy, including high dose cisplatin in adults. In Canada, the product is also indicated in pediatric patients aged 2 to 17 years for the prevention of acute nausea and vomiting associated with moderately and highly emetogenic cancer chemotherapy. ALOXI® oral is approved in Canada for use in adults for the prevention of acute nausea and vomiting associated with moderately emetogenic cancer chemotherapy. According to IQVIA, sales of AKYNZEO® in Canada and Brazil were approximately $7 million in 2021. Knight assumed commercial activities of AKYNZEO® in Brazil and Argentina in July 2022 and will begin commercial activities following a transition period from Helsinn's current licensees in Canada.

Knight entered into exclusive license and supply agreements with Rigel Pharmaceuticals for the exclusive rights to commercialize fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, in Latin America. Fostamatinib is commercially available in the United States under the brand name TAVALISSE® and in Europe under the brand name TAVLESSE® for the treatment of chronic immune thrombocytopenia. On June 8, 2022, Rigel announced topline efficacy and safety data from the Phase 3 clinical trial of fostamatinib in patients with warm autoimmune hemolytic anemia (wAIHA). The trial did not demonstrate statistical significance in the primary efficacy endpoint of durable hemoglobin response in the overall study population. The safety profile was consistent with prior clinical experience, and no new safety issues were identified. Rigel is conducting an in-depth analysis of this data to better understand differences in patient characteristics and outcomes and expects to discuss these findings with the FDA to determine the path forward in wAIHA. Fostamatinib is also in Phase 3 clinical trials for the treatment of hospitalized patients with COVID-19 1,2 .

_______________

1 Clinicaltrials.gov: NCT04629703
2 Clinicaltrials.gov: NCT04924660


Corporate Updates

NCIB

On July 12, 2022, the Company announced that the Toronto Stock Exchange approved its notice of intention to launch a NCIB ("2022 NCIB"). Under the terms of the 2022 NCIB, Knight may purchase for cancellation up to 7,988,986 common shares of the Company which represented 10% of its public float as at June 30, 2022. The 2022 NCIB commenced on July 14, 2022 and will end on the earlier of July 13, 2023 or when the Company completes its maximum purchases under the NCIB. Furthermore, Knight entered into an agreement with a broker to facilitate purchases of its common shares under the NCIB. Under Knight's automatic share purchase plan, the broker may purchase common shares which would ordinarily not be permitted due to regulatory restrictions or self-imposed blackout periods.

For the three-month period ended June 30, 2022, the Company purchased 1,460,684 common shares at an average price of $5.30 for an aggregate cash consideration of $7,739. The Company did not acquire any common shares subsequent to the quarter ended June 30, 2022.

Settlement Agreement

Knight executed a settlement agreement and general release ("Settlement Agreement") with the former shareholders of GBT. The Company made certain claims ("Claims") with respect to its indemnification rights under the purchase agreement for the acquisition of GBT. Under the Settlement Agreement, Knight will receive $5.9 million (US$4.6 million) as settlement for the Claims, which will be recorded in the Statement of Income.

Conference Call Notice

Knight will host a conference call and audio webcast to discuss its second quarter ended June 30, 2022, today at 8:30 am ET. Knight cordially invites all interested parties to participate in this call.

Date: Thursday, August 11, 2022
Time: 8:30 a.m. ET
Telephone : Toll Free: 1-855-669-9657 or International 1-412-317-0790
Webcast: www.gud-knight.com or Webcast
This is a listen-only audio webcast. Media Player is required to listen to the broadcast.

Replay: An archived replay will be available for 30 days at www.gud-knight.com

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Bausch Health to Appeal XIFAXAN® Patent Decision to U.S. Court of Appeals for the Federal Circuit

Bausch Health Companies Inc. (NYSETSX: BHC), and its gastroenterology business Salix Pharmaceuticals, today announced that, consistent with the company's July 28, 2022 press release, the U.S. District Court of Delaware has issued a decision in the matter of Salix Pharmaceuticals, Ltd. et al v. Norwich Pharmaceuticals, Inc. finding certain XIFAXAN® (rifaximin) 550 mg HE patents valid and infringed and certain XIFAXAN composition and IBS-D patents invalid.  As previously stated, the Company will appeal this decision to the U.S. Court of Appeals for the Federal Circuit and it expects an appeal decision to issue within 12 to 18 months.

To date, Norwich has not received tentative or final approval of its ANDA from the FDA.  Unless and until FDA approves a revised Norwich ANDA that omits the XIFAXAN HE indication, and any injunction issued by the Court is modified, Norwich is not permitted to launch a generic equivalent of XIFAXIN.

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Medtronic to announce financial results for its first quarter of fiscal year 2023

Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced that it will report financial results for its first quarter of fiscal year 2023 on Tuesday, August 23, 2022 . A news release will be issued at approximately 5:45 a.m. Central Daylight Time (CDT) and will be available at https:news.medtronic.com . The news release will include summary financial information for the company's first quarter of fiscal year 2023, which ended on Friday, July 29, 2022 .

Medtronic will host a video webcast at 7:00 a.m. CDT on Tuesday, August 23, 2022 , to discuss results for its first quarter of fiscal year 2023. The webcast can be accessed at https://investorrelations.medtronic.com .

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Salix Supports CMS Announcement of First ICD-10 Code for Hepatic Encephalopathy

CMS Issues New Specific ICD-10 Code K76.82 for HE

Bausch Health Companies Inc. (NYSETSX: BHC) ("Bausch Health") and its gastroenterology business, Salix Pharmaceuticals, ("Salix"), one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal (GI) and liver diseases and disorders, today announced its support of the publication of a new specific ICD-10 code from the Centers for Medicare & Medicaid Services (CMS) for hepatic encephalopathy (HE) based on the growing incidence of chronic liver disease in the United States.

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