Medical Device Investing News

Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced the U.S. Food and Drug Administration (FDA) has approved revised commercial labeling for the Intellis™ Platform with Differential Target Multiplexed (DTM™) programming for the treatment of chronic, intractable back and leg pain. The new labeling will include study outcomes from a multicenter randomized control trial reflecting superior back pain relief with DTM SCS when compared to conventional SCS.

The trial demonstrated with clinical and statistical significance that DTM SCS programming is superior to conventional SCS programming when used to treat intractable chronic back pain. At 3 months, 80% of patients treated with DTM SCS reported back pain relief of at least 50%, compared with 51% of patients treated with conventional SCS as measured by the Visual Analog Scale (VAS), a widely used and accepted measure for pain intensity. 1

This labeling update closely follows the most recent presentation of 12-month clinical trial outcomes during a late-breaking clinical trial session at NANS 2021. 2 Trial results showed statistically significant and superior back pain relief with DTM SCS compared to conventional SCS at 12 months: 84% of patients with chronic back pain treated with DTM SCS reported at least 50% pain relief, compared to 51% of patients treated with conventional SCS. There was also a difference in the proportion of patients who reported profound back pain relief ( > 80% reduction in VAS score) favoring DTM SCS (69%) compared with conventional SCS (35.1%). 2

"The body of clinical evidence proving the efficacy of DTM SCS in treating patients with chronic back pain continues to grow," said Charlie Covert , vice president and general manager, Pain Therapies within the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic. "The updated labeling further strengthens the credibility of the outcomes from this therapy, and parallels the profound benefits our clinician partners are seeing with their own patients."

DTM therapy, which is clinically proven and only available on the Medtronic Intellis platform, is a unique and proprietary programming option available to treat patients with chronic pain that is based on years of preclinical research. 3,4,5

Clinical trial data can be found www.medtronic.com/DTM . A manuscript has been submitted for consideration for peer-reviewed publication.

About the Intellis™ Platform
The Intellis platform offers the world's smallest implantable neurostimulator. It is powered by proprietary Overdrive™ battery technology and was designed to overcome limitations with other SCS systems, optimized for a wide range of energy demands and provides effective long-term pain relief for patients. The neurostimulator also features SureScan™ MRI technology, allowing access to MRI anywhere in the body under certain conditions, and AdaptiveStim™ technology, which automatically adjusts stimulation based on the patient's needs and preferences in different body positions to ensure the patient receives the right dose of stimulation at the right location.

About Medtronic Pain Therapies
Medtronic has more than a 40-year history of developing innovative medical devices that have been shown to alleviate pain in different disease states and has a broad portfolio of device-delivered therapies that are alternatives or adjuncts to oral opioids. 4 Medtronic strives to be at the forefront of medical device innovation and to develop high-quality pain therapies that reduce pain and improve quality of life. While Medtronic pain therapies do not treat opioid addiction, we are committed to leveraging our capabilities and product portfolio in partnership with stakeholders — patients, providers, payers, regulators, elected officials, patient advocacy groups and employers — to address the unmet needs of pain patients and to support efforts to prevent opioid misuse due to chronic intractable pain.

About Medtronic
Medtronic plc ( www.medtronic.com ), headquartered in Dublin, Ireland , is among the world's largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

References

  1. Fishman M, Cordner H, Justiz R, et al. Randomized Controlled Clinical Trial to Study the Effects of SGX-SCS in Treating Intractable Chronic Low Back Pain: 3 Month Results. North American Neuromodulation Society (NANS); 2020; Las Vegas, Nevada .
  2. Fishman M, Cordner H, Justiz R, et al. Randomized Controlled Clinical Trial to Study the Effects of Differential Target Multiplexed™ SCS (DTM TM SCS) in Treating Intractable Chronic Low Back Pain: Long-term Follow-Up Results. Presented at: North American Neuromodulation Society 24 th Annual Meeting. Jan 15-16, 2021 . Virtual.
  3. Vallejo R, Kelley CA, Gupta A, Smith WJ, Vallejo A, Cedeño DL. Modulation of neuroglial interactions using differential target multiplexed spinal cord stimulation in an animal model of neuropathic pain. Mol Pain. 2020 Jan-Dec;16:1744806920918057. http://dx.doi.org/10.1177/1744806920918057
  4. Vallejo R, Tilley DM, Vogel L, Benyamin R. The role of glia and the immune system in the development and maintenance of neuropathic pain. Pain Pract. 2010 May-Jun;10(3):167-84.
  5. Cedeno DL, Smith WJ, Kelley CA, Vallejo R. Spinal cord stimulation using differential target multiplexed programming modulates neural cell-specific transcriptomes in an animal model of neuropathic pain. Mol Pain. 2020;16:1744806920964360. http://dx.doi.org/10.1177/1744806920964360

Contacts:

Jeff Trauring

Ryan Weispfenning

Public Relations

Investor Relations

+1-763-505-0159

+1-763-505-4626

Medtronic plc (PRNewsfoto/Medtronic plc)

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Johnson & Johnson Ends Global Sales of Cancer-Causing Baby Powder Amid Increased Scrutiny from Consumer Litigation, Science

Courts continue to scrutinize J&J's controversial bankruptcy ploy to avoid liability

Legal experts say the decision by Johnson & Johnson (NYSE: JNJ) to halt future sales and distribution of talc-based products worldwide, including its iconic Johnson's Baby Powder, points to mounting pressure on the company to resolve tens of thousands of legal claims brought by ovarian cancer and mesothelioma victims.

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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.

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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-STAT™ 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-STAT™ 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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