Knight Therapeutics Reports First Quarter 2021 Results

Knight Therapeutics Inc. (TSX: GUD) ("Knight" or "the Company"), a leading pan-American (ex-US) specialty pharmaceutical company, today reported financial results for its first quarter ended March 31, 2021. All currency amounts are in thousands except for share and per share amounts. All currencies are Canadian unless otherwise specified.

Q1 2021 Highlights

Financials

  • Revenues were $46,069, an increase of $230 or 1% over prior year.
  • Gross margin generated of $20,580 or 45% compared to $19,860 or 43% in prior year.
  • Adjusted EBITDA 1 was $5,580, an increase of $2,383 or 75% over prior year.
  • Interest income generated of $1,998 a decrease of $2,651 or 57% over prior year.
  • Net income was $3,558 compared to net loss of $9,477 in prior year.
  • Cash inflow from operations was $17,207 compared to cash outflow of $21,167 in prior year.

Corporate Developments

  • Promoted Amal Khouri to Chief Business Officer.
  • Purchased 3,557,340 common shares through a Normal Course Issuer Bid ("NCIB") for an average cost of $18,592.

Products

  • Launched Ibsrela™ in Canada for the treatment of Irritable Bowel Syndrome with Constipation ("IBS-C").

Strategic Investments

  • Disposed of 315,600 common shares of Medexus for total proceeds of $2,624.
  • Received distributions of $4,336 from strategic fund investments and realized a gain of $3,031.

Key Subsequent Events

  • Entered into a definitive agreement with Novartis to acquire the exclusive rights to manufacture, market and sell Exelon® in Canada and LATAM for an upfront payment of USD 168,000 ($211,260 2 ) and a milestone payment of up to USD 12,000 ($15,090 2 ).
  • Shareholders re-elected James C. Gale, Jonathan Ross Goodman, Samira Sakhia, Robert N. Lande, Michael J. Tremblay, Nicolás Sujoy and Janice Murray on the Board of Directors.
  • Announced leadership change with Samira Sakhia assuming role of CEO and Jonathan Goodman assuming role of Executive Chairman effective September 1, 2021.
  • Purchased 512,271 common shares through its NCIB for an aggregate cost of $2,695.

"We are continuing to execute on multiple fronts. I am excited to report that our key launch brands in Latin America, including Cresemba®, Halaven®, Lenvima®, Trelstar® and Nerlynx® in Canada grew 116% compared to the prior year quarter.   We continue to progress on our integration activities and have commenced implementation of our ERP, CRM and HR and learning management systems. On the business development front, we executed on another transformational transaction with the acquisition of Exelon® from Novartis for Canada and Latin America, said Samira Sakhia, President and Chief Operating Officer of Knight Therapeutics Inc. "I am humbled and honored to be leading talented Knights in Canada and across Latin America as we continue to execute on our strategy of acquiring, in-licensing and developing innovative medicines and high quality treatments for Latin America and Canada."

1
A   djusted EBITDA   is   not defined term   s   under IFRS, refer to   the definition   s   below for additional details   .
2 Converted   to CAD using the closing   foreign exchange rate, actual amount in CAD will vary depending on the exchange rate on the close of the transaction


SELECT FINANCIAL RESULTS & BALANCE SHEET ITEMS

[In thousands of Canadian dollars]

Change
Q1-21 Q1-20 $ 1 % 2
Revenues 46,069 45,839 230 1 %
Gross margin 20,580 19,860 720 4 %
Selling and marketing 7,613 10,114 2,501 25 %
General and administrative 7,082 8,418 1,336 16 %
Research and development 2,818 2,749 (69 ) 3 %
Amortization of intangible assets 5,302 6,039 737 12 %
Operating loss (2,235 ) (7,460 ) 5,225 70 %
Interest income (1,998 ) (4,649 ) (2,651 ) 57 %
Interest expense 660 1,147 487 42 %
Foreign exchange loss 4,201 4,907 706 14 %
Net income (loss) 3,558 (9,477 ) 13,035 N/A
Basic net earnings (loss) per share 0.028 (0.013 ) 0.041 N/A
Adjusted EBITDA 3 5,580 3,197 2,383 75 %
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 Adjusted EBITDA is a non-IFRS measure, refer to section "Non-IFRS measure: EBITDA and Adjusted EBITDA" for additional details


Change
03-31-21 12-31-20 $ % 1
Cash, cash equivalents and marketable securities 382,381 392,225 (9,844 ) 3 %
Trade and other receivables 104,310 116,510 (12,200 ) 10 %
Inventory 55,044 56,505 (1,461 ) 3 %
Financial assets 193,922 193,955 (33 ) 0 %
Accounts payable and accrued liabilities 45,693 44,828 865 2 %
Bank loans 38,192 51,770 (13,578 ) 26 %
1 Percentage change is presented in absolute values

Revenue: For the quarter ended March 31, 2021, revenues increased by $230 or 1% as a result of an increase in sales from new product launches, partially offset by the depreciation in the LATAM currencies. Excluding the impact of hyperinflation and under constant currency, revenues would have increased by $4,123, which is mainly attributable to the launch of Cresemba®, Lenvima®, Halaven®, Nerlynx® and certain BGx products as well as Trelstar®, which Knight began commercializing in April 2020.

Gross margin: For the quarter ended March 31, 2021, the gross margin increased from 43% to 45% compared to the same period in the prior year due to lower inventory provision and product mix, partially offset by re-negotiation of certain license agreements and the depreciation of the LATAM currencies. The gross margin would have been 47%, an increase of 2%, from 45% after excluding the adjustment of hyperinflation accounting in accordance with IAS 29.

Selling and marketing: The decrease of $2,501 or 25% for the quarter ended March 31, 2021 compared to the same period in the prior year is due to $1,133 of expected credit loss that was recorded in Q1 20 compared to none in Q1 21 and $783 due to the depreciation of the LATAM currencies.

General and administrative: For the quarter ended March 31, 2021, the general and administrative expenses decreased by $1,336 or 16% as compared to the same period in prior year driven by $671 in savings due to restructuring activities and $789 due to the depreciation of the LATAM currencies.

Amortization of intangible assets: For the quarter ended March 31, 2021, amortization of intangible assets decreased by $737, or 12%, mainly explained by the depreciation in the LATAM currencies partially offset by the amortization of intangible assets acquired during 2020.

Interest income: Interest income is the sum of interest income on financial instruments measured at amortized cost and other interest income. For the quarter, interest income was $1,998, a decrease of 57% or $2,651 compared to the same prior year period due to a decrease in interest rates, the average cash and marketable securities balances and a lower average loan balance.

Interest expense: The interest expense relates to interest incurred on bank loans. For the quarter ended March 31, 2021 interest expenses was $660, a decrease of $487 or 42% compared to the same period in the prior year due to decrease in the average loan balance outstanding.

Adjusted EBITDA : For the three-month period ended March 31, 2021, adjusted EBITDA was $5,580, an increase of $2,383 or 75% compared to the same period last year. The variance is explained by the above mentioned increase in gross margin and decrease in operating expenses.

Net income or loss: For the quarter ended March 31, 2021, net income was $3,558 compared to a net loss of $9,477 for the same period last year. The variance mainly resulted from the above-mentioned items as well as a net gain on the revaluation of financial assets measured at fair value through profit or loss of $9,473 in the first quarter of 2021 versus a loss of $6,730 in the prior year period.

Cash, cash equivalents and marketable securities : As at March 31, 2021, Knight had $382,381 in cash, cash equivalents and marketable securities, a decrease of $9,844 or 3% as compared to December 31, 2020. The variance is primarily due to cash outflows related to the shares repurchased through NCIB, the bank loans repaid by Knight offset by cash generated from operating activities.

Financial assets: There is no significant variance for financial assets. However, given the nature of the fund investments there could be significant fluctuations in the fair value of the underlying assets. More specifically, an investment held within Sectoral Asset Management ("Sectoral") fund, Atea Pharmaceutics Inc ("Atea"), announced in October 2020, the closing of its initial public offering at a public offering price of USD 24 per share. The shares held by Sectoral are subject to a 180-day lockup period. As at March 31, 2021, Atea's share price closed at USD 61.75 compared to USD 41.78 as at December 31, 2020. As at May 12, 2021, Atea's share price closed at USD 19.74 Should the share price of Atea remain at this level, the Company would record a loss of approximately $15.2M.

Bank Loans: As at March 31, 2021, bank loans were at $38,192, a decrease of $13,578 as compared to the prior period, mainly due to loan repayment of $8,848 and a further decrease of $4,854 due to the foreign exchange revaluation.

Product Updates

On March 1, 2021 the Company launched Ibsrela™ (tenapenor) for the treatment of IBS-C. The Company entered into an exclusive licensing agreement with Ardelyx to commercialize Ibsrela™ in Canada in March 2018. Ibsrela™ is a first-in-class small molecule treatment for IBS-C. Ardelyx received regulatory approval for Ibsrela™ from the US FDA in September 2019. On April 17, 2020, the Company announced that Ibsrela™ was approved by Health Canada.

On April 23, 2021, the Company announced that it has entered into a definitive agreement to acquire the exclusive rights to manufacture, market and sell Exelon®, indicated for the symptomatic treatment of mild to moderately severe dementia in people with Alzheimer's disease, in Canada and Latin America ("Territory"). In addition, the Company obtained an exclusive license to use the intellectual property and the Exelon trademark in the Territory. At closing, Knight will pay USD 168,000 ($211,260 1 ) in cash and may pay up to USD 12,000 ($15,090 1 ) upon the achievement of certain conditions. For the year ended December 31, 2020, Exelon® sales in the Territory were approximately USD 47,000.

The closing of this transaction is subject to the completion of the anti-trust clearance process in Brazil. In conjunction with closing, Knight will enter into a transition service agreement until transfer of marketing authorization, on a country by country basis during which Knight will receive a net profit transfer. Knight will begin distributing Exelon upon transfer of marketing authorization, on a country by country basis.

NCIB

On July 10, 2020, the Company announced that the Toronto Stock Exchange approved its notice of intention to launch an additional NCIB (‘2020 NCIB"). Under the terms of the 2020 NCIB, Knight may purchase for cancellation up to 10,856,710 common shares of the Company which represented 10% of its public float as at July 6, 2020. The 2020 NCIB commenced on July 14, 2020 and will end on the earlier of July 13, 2021 or when the Company completes its maximum purchases under the 2020 NCIB. Furthermore, Knight entered into an agreement with a broker to facilitate purchases of its common shares under the 2020 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. During the three-month period ended March 31, 2021, the Company purchased 3,557,340 common shares, for an aggregate cash consideration of $18,592, of which $44 remains to be settled as at March 31, 2021. Subsequent to the quarter, the Company purchased an additional 512,271 common shares, for an aggregate cash consideration of $2,695.

1 Converted using the March 31, 2021 closing foreign exchange rate, actual amount in CAD will vary depending on the exchange rate on the close of the transaction.


Conference Call Notice

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

Date: Friday, May 14, 2021
Time: 8:30 a.m. ET
Telephone: : Toll Free 888-506-0062 or International 973-528-001
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


About Knight Therapeutics Inc.

Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing innovative pharmaceutical products for Canada and Latin America. Knight owns Biotoscana Investments S.A., a pan-Latin American specialty pharmaceutical company. Knight Therapeutics Inc.'s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at www.gud-knight.com or www.sedar.com .

Forward-Looking Statement

This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2020 as filed on www.sedar.com . Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information or future events, except as required by law.

CONTACT INFORMATION:

Investor Contact:
Knight Therapeutics Inc.
Samira Sakhia Arvind Utchanah
President & Chief Operating Officer Chief Financial Officer
T: 514.484.4483 ext.122 T. 514.484.4483 ext. 115
F: 514.481.4116 F. 514.481.4116
Email: info@knighttx.com Email: info@knighttx.com
Website: www.gud-knight.com Website: www.gud-knight.com



IMPACT OF HYPERINFLATION

[In thousands of Canadian dollars]

The Company applies IAS 29, Financial Reporting in Hyperinflation Economies, as the Company's Argentine subsidiaries used the Argentine Peso as their functional currency. IAS 29 requires that the financial statements of an entity whose functional currency is the currency of a hyperinflationary economy be adjusted based on an appropriate general price index to express the effects of inflation. If the Company did not apply IAS 29, the effect on the Company's operating income would be as follows:

Q1-21

Reported
under IFRS

Excluding impact
of IAS 29

Variance
$ 1 % 2
Revenues 46,069 46,082 (13 ) 0 %
Cost of goods sold 25,489 24,376 (1,113 ) 5 %
Gross margin 20,580 21,706 (1,126 ) 5 %
Gross margin (%) 45   % 47   %
Expenses
Selling and marketing 7,613 7,614 1 0 %
General and administrative 7,082 6,874 (208 ) 3 %
Research and development 2,818 2,770 (48 ) 2 %
Amortization of intangible assets 5,302 5,086 (216 ) 4 %
Operating loss (2,235 ) (638 ) (1,597 ) 250 %
1 A positive variance represents a positive impact to net income due to the application of IAS 29 and a negative variance represents a negative impact to net income due to the application of IAS 29
2 Percentage change is presented in absolute values



CONSTANT CURRENCY

[In thousands of Canadian dollars]

Financial results at constant currency allow results to be viewed without the impact of fluctuations in foreign currency exchange rates thereby facilitating the comparison of results period over period. The presentation of results under constant currency is considered to be a non-GAPP measure and does not have any standardized meaning under GAAP. As a result, the information presented may not be comparable to similar measures presented by other companies.

Financial results at constant currency are obtained by translating the prior period results at the average foreign exchange rates in effect during the current period. Furthermore, with respect to Argentina, for both Q1-20 and Q1-21, the Company excludes the impact of hyperinflation and translates the results at the average exchange rate in effect for each of the periods.

Q1-21 Q1-20 Variance Q1-20 Impact of FX on 2020
Excluding impact of IAS 29
Constant
Currency
$ 1
% 2 $ 1 % 2
Revenues 46,082 41,959 4,123 10 % 45,488 (3,529 ) 8 %
Cost of goods sold 24,376 22,045 (2,331 ) 11 % 25,015 2,970 12 %
Gross margin 21,706 19,914 1,792 9 % 20,473 (559 ) 3 %
Gross margin (%) 47   % 47   % 45%
Expenses
Selling and marketing 7,614 9,250 1,636 18 % 9,988 738 7 %
General and administrative 6,874 7,545 671 9 % 8,334 789 9 %
Research and development 2,770 2,632 (138 ) 5 % 2,721 89 3 %
Amortization of intangible assets 5,086 5,112 26 1 % 5,559 447 8 %
Operating loss (638 ) (4,625 ) 3,987 86 % (6,129 ) 1,504 25 %
EBITDA 5,160 1,018 4,142 407 % 1,217 (199 ) 16 %
Adjusted EBITDA 5,580 2,395 3,185 133 % 3,197 (802 ) 25 %
1 A positive variance represents a positive impact to net income and a negative variance represents a negative impact to net income
2 Percentage change is presented in absolute values


RECONCILIATION TO ADJUSTED EBITDA
[In thousands of Canadian dollars]

Non-IFRS measures: EBITDA and Adjusted EBITDA

The Company discloses non-IFRS measures that do not have standardized meanings prescribed by IFRS. The Company believes that shareholders, investment analysts and other readers find such measures helpful in understanding the Company's financial performance and in interpreting the effect of the GBT Transaction on the Company. Non-IFRS financial measures do not have any standardized meaning prescribed by IFRS and may not have been calculated in the same way as similarly named financial measures presented by other companies.

The Company uses the following non-IFRS measures:

EBITDA: Operating loss adjusted to exclude amortization and impairment of intangible assets, depreciation, PPA accounting adjustments, and the impact of IAS 29 (accounting under hyperinflation) but to include costs related to leases. In addition, EBITDA does not reflect the portion of GBT's results attributable to the non-controlling interests.

Adjusted EBITDA: EBITDA adjusted for acquisition costs and non-recurring expenses.

Adjustments include the following:

  • With the adoption of IFRS 16, the lease payments of Knight are not reflected in operating expenses. The IFRS 16 adjustment approximates the cash outflow related to leases of Knight.
  • Acquisition costs relate to costs incurred on legal, consulting and advisory fees for the acquisition of GBT and products.
  • Other non-recurring expenses relate to expenses incurred by Knight that are not due to, and are not expected to occur in, the ordinary course of business. For the quarter ended March 31, 2021, Knight recorded one-time costs of $70 related to restructuring activities including severance to certain employees as part of restructuring and integration of GBT.

For the three-month period ended March 31, the Company calculated EBITDA and adjusted EBITDA as follows:

Q1-21 Q1-20
Operating loss (2,235 ) (7,460 )
Adjustments to operating loss:
Amortization of intangible assets 5,302 6,039
Depreciation of property, plant and equipment and ROU assets 1,406 1,724
Lease costs (IFRS 16 adjustment) (694 ) (834 )
Impact of PPA accounting 632
Impact of IAS 29 1,381 1,116
EBITDA 5,160 1,217
Acquisition and transaction costs 350 216
Other non-recurring expenses 70 1,764
Adjusted EBITDA 5,580 3,197



INTERIM CONSOLIDATED BALANCE SHEETS

[In thousands of Canadian dollars]
[Unaudited]



As at
March 31, 2021 December 31, 2020
ASSETS
Current
Cash and cash equivalents 271,218 229,592
Marketable securities 111,163 147,316
Trade receivables 52,682 62,515
Other receivables 10,046 12,413
Inventories 55,044 56,505
Prepaids and deposits 2,007 2,214
Other current financial assets 40,069 34,431
Income taxes receivable 7,855 7,115
Total current assets 550,084 552,101
Marketable securities 15,317
Prepaids and deposits 2,875 4,208
Right-of-use assets 3,623 4,035
Property, plant and equipment 22,476 22,127
Investment properties 1,414 1,539
Intangible assets 146,227 156,547
Goodwill 74,091 77,725
Other financial assets 153,853 159,524
Deferred income tax assets 2,137 2,432
Other long-term receivables 41,582 41,582
448,278 485,036
Assets held for sale 2,433 2,539
Total assets 1,000,795 1,039,676




INTERIM CONSOLIDATED BALANCE SHEETS (continued)

[In thousands of Canadian dollars]
[Unaudited]

March 31, 2021 December 31, 2020
LIABILITIES AND EQUITY
Current
Accounts payable and accrued liabilities 45,385 44,512
Lease liabilities 1,530 1,875
Other liabilities 1,768 1,291
Automatic share purchase plan liability 31,272
Bank loans 38,192 51,770
Income taxes payable 14,390 13,559
Other balances payable 3,408 1,053
Total current liabilities 135,945 114,060
Accounts payable and accrued liabilities 308 316
Lease liabilities 2,174 2,543
Other balances payable 12,687 14,900
Deferred income tax liabilities 20,206 21,616
Total liabilities 171,320 153,435
Shareholders' Equity
Share capital 641,461 694,351
Warrants 117 117
Contributed surplus 19,242 18,731
Accumulated other comprehensive loss (12,552 ) (1,503 )
Retained earnings 181,207 174,545
Total shareholders' equity 829,475 886,241
Total liabilities and   shareholders'   equity 1,000,795 1,039,676



INTERIM CONSOLIDATED STATEMENTS OF INCOME (LOSS)

[In thousands of Canadian dollars, except for share and per share amounts]
[Unaudited]

Three months ended March 31,  
2021 2020
Revenues 46,069 45,839
Cost of goods sold 25,489 25,979
Gross margin 20,580 19,860
Expenses
Selling and marketing 7,613 10,114
General and administrative 7,082 8,418
Research and development 2,818 2,749
Amortization of intangible assets 5,302 6,039
Operating loss (2,235 ) (7,460 )
Interest income on financial instruments measured at amortized cost (886 ) (3,383 )
Other interest income (1,112 ) (1,266 )
Interest expense 660 1,147
Other income (112 ) (25 )
Net (gain) loss on financial instruments measured at fair value through profit or loss (9,473 ) 6,730
Net loss on mandatory tender offer liability 487
Realized gain on sale of asset held for sale (2,948 )
Realized gain on automatic share purchase plan (2,869 )
Foreign exchange loss 4,201 4,907
Loss on hyperinflation 60 277
Income (loss) before income taxes 4,427 (10,517 )
Income tax
Current 648 3,001
Deferred 221 (4,041 )
Income tax expense (recovery) 869 (1,040 )
Net income (loss) for the period 3,558 (9,477 )
Attributable to:
Shareholders of the Company 3,558 (1,709 )
Non-controlling interests (7,768 )
Attributable to shareholders of the Company
Basic earnings (loss) per share 0.03 (0.01 )
Diluted earnings (loss) per share 0.03 (0.01 )
Weighted average number of common shares outstanding
Basic 128,841,383 135,144,152
Diluted 128,843,728 135,436,500




INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS

[In thousands of Canadian dollars]
[Unaudited]

Three months ended March 31,  
2021 2020
OPERATING ACTIVITIES
Net income (loss) for the period 3,558 (9,477 )
Adjustments reconciling net income to operating cash flows:
Depreciation and amortization 6,708 7,763
Net (gain) loss on financial instruments (9,473 ) 6,730
Unrealized foreign exchange loss 4,657 4,907
Other operating activities 1,452 (8,457 )
6,902 1,466
Changes in non-cash working capital and other items 10,628 (22,472 )
Interest payments on bank loans (323 ) (161 )
Cash inflow (outflow) from operating activities 17,207 (21,167 )
INVESTING ACTIVITIES
Purchase of marketable securities (31,792 ) (13,415 )
Proceeds on maturity of marketable securities 83,156 76,446
Proceeds from distribution of funds 4,336 2,090
Other investing activities 220 70,909
Cash inflow from investing activities 55,920 136,030
FINANCING ACTIVITIES
Repurchase of common shares through Normal Course Issuer Bid (18,549 ) (13,311 )
Principal repayment on bank loans (8,848 ) (731 )
Other financing activities (630 ) 11,168
Cash outflow from financing activities (28,027 ) (2,874 )
Increase in cash and cash equivalents during the period 45,100 111,989
Cash and cash equivalents, beginning of the period 229,592 174,268
Net foreign exchange difference (3,474 ) 685
Cash and cash equivalents, end of the period 271,218 286,942
Cash and cash equivalents 271,218 286,942
Short-term marketable securities 111,163 246,575
Long-term marketable securities 59,061
Total cash, cash equivalents and marketable securities 382,381 592,578

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Medtronic Affera pulsed field ablation technologies continue to demonstrate promising evidence for atrial fibrillation patients

Medtronic Affera pulsed field ablation technologies continue to demonstrate promising evidence for atrial fibrillation patients

  • One-year clinical trial data for the next-generation, investigational, Sphere-360™ single-shot PFA catheter show impressive safety, performance, and efficiency results for paroxysmal Afib
  • Dual-energy (RF/PF), focal Sphere-9™ catheter demonstrates efficacy for linear ablation in persistent AFib
  • Medtronic continues legacy of leadership in innovation, showcasing arrhythmia management portfolio at Heart Rhythm Society annual meeting

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced positive clinical outcomes from two studies in atrial fibrillation (AFib) patients treated with the Affera™ family of technologies, including the next-generation Sphere-360™ single-shot pulsed field ablation (PFA) catheter and the groundbreaking Sphere-9™ combination mapping and dual-energy focal PFA catheter. Data were presented in High Impact Science Sessions at the Heart Rhythm Society 2025 Annual Meeting in San Diego ; the Sphere-360 study was simultaneously published in the Heart Rhythm Journal .

(PRNewsfoto/Medtronic plc)

Sphere-360 Study Safety and Performance

Sphere-360 is an investigational, first-of-its-kind, single-shot PFA mapping and ablation catheter for treatment of paroxysmal atrial fibrillation (PAF). Results for Sphere-360 at one year, in a prospective, single-arm, multi-center trial performed in European centers, demonstrated freedom from arrhythmia recurrence in 88% of patients, with chronically durable pulmonary vein isolation (PVI) in 98% of targeted veins and no reported safety events in a sub-group treated with the most optimized waveform. The Sphere-360 catheter has a large, conformable lattice design that can be modified into various shapes, is seamlessly integrated with the Affera Mapping and Ablation System and utilizes an 8.5 Fr sheath – the smallest in any single-shot PFA technology.

"The Affera technology is a sophisticated ecosystem, including an advanced, intuitive mapping system and catheters that are seamlessly integrated to offer treatment options for different cardiac arrhythmias. It is encouraging to see the promising results for Sphere-360, which can easily create circumferential lesions without the need for catheter rotation," said Vivek Reddy , M.D., Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City . "The study results showed Sphere-360 has a promising safety and performance profile with zero serious adverse events observed. Upon approval, Sphere-360 will be a valuable addition to Medtronic's Affera system, which has been a game changer for Afib treatment and physician workflow."

Medtronic intends to begin its U.S. pivotal trial for the Sphere-360 catheter later this calendar year. Worldwide, Sphere-360 is currently investigational and not approved for sale or distribution.

Sphere-9 for Linear Ablation

Additionally, in a sub-analysis from the Sphere Per-AF IDE study , results demonstrated that the Sphere-9 catheter can be used safely and effectively to create linear lesions in persistent AF patients. Linear ablation is often used in conjunction with PVI to improve the chances of restoring a normal heart rhythm without recurrence in persistent AF patients. The Sphere Per-AF IDE study evaluated the safety, efficacy and efficiency of Affera and Sphere-9 in persistent AF and led to the FDA approval of Affera in October 2024 .

"True to our Medtronic mission for patients and legacy of innovation, we are delivering our best-in-class technologies to physicians and improving care for AFib patients, and we are not slowing down," said Rebecca Seidel , president of the Cardiac Ablation Solutions business at Medtronic, which is part of the Cardiovascular portfolio. "These results signify another step forward and energize us as we continue to earn and build our leadership position in electrophysiology every day."

Medtronic is the only company with two PFA offerings for physicians and patients. The PulseSelect™ Pulsed Field Ablation System offers physicians a safe, single-shot solution for pulmonary vein isolation (PVI) and is now available in more than 30 countries. The Affera system together with the Sphere-9 catheter enables physician treatment flexibility with its wide area focal design and 9mm lattice tip that can used with an 8.5Fr sheath. Affera is available in Europe , Australia and New Zealand , with global expansion ongoing.

AFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide. 1 Afib is a progressive disease, often beginning as paroxysmal AFib (presents intermittently) and progressing to persistent (lasts for more than 7+ days without stopping). As the disease progresses, the risk of serious complications including heart failure, stroke and risk of death increases 2-5 .

For more information on the Affera PFA system and the Sphere-9 catheter, visit Medtronic.com.

About Medtronic

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .

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. Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.
  2. Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92.
  3. Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020.
  4. Wolf PA , Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.
  5. Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126

Dr. Reddy is a paid consultant for Medtronic.

Contacts:
Leslie Williamson
Public Relations
+1-612-227-5099

Ryan Weispfenning
Investor Relations
+1-763-505-4626

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SOURCE Medtronic plc

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Medtronic Expand URO U.S. clinical trial meets safety and effectiveness primary endpoints for Hugo robotic-assisted surgery system

Medtronic Expand URO U.S. clinical trial meets safety and effectiveness primary endpoints for Hugo robotic-assisted surgery system

Largest multi-center prospective Investigational Device Exemption (IDE) study for multi-port robotic-assisted urologic surgery   in the U.S. presented as a late-breaker at the American Urologic Association annual meeting

Company confirms Hugo RAS system submission to the U.S. Food and Drug Administration

Medtronic (NYSE: MDT), a global leader in healthcare technology, today announced that the Expand URO Investigational Device Exemption (IDE) clinical study, the largest such study for robotic-assisted urologic surgery ever conducted, met both primary safety and effectiveness endpoints. The prospective, multi-center, single-arm IDE study included 137 patients who underwent urologic procedures using the Hugo™ robotic-assisted surgery (RAS) system.

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Medtronic receives FDA approval for smallest-diameter, lumenless defibrillation lead, the OmniaSecure lead and announces investigational clinical study results

Medtronic receives FDA approval for smallest-diameter, lumenless defibrillation lead, the OmniaSecure lead and announces investigational clinical study results

Adding to the Medtronic portfolio of catheter-based lead solutions, the novel OmniaSecure defibrillation lead allows for precise delivery and placement in the right ventricle

Heart Rhythm 2025: Late-breaking clinical study results evaluating the OmniaSecure lead for investigational use in the LBBAP location show high defibrillation success

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Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump

Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced it has submitted 510(k) applications to the U.S. Food and Drug Administration (FDA) seeking clearance for an interoperable pump. FDA clearance of this pump would pave the way for system integration with a continuous glucose monitoring (CGM) sensor based on Abbott's most advanced CGM platform.

(PRNewsfoto/Medtronic plc)

The submissions included a 510(k) application for its MiniMed™ 780G pump as an alternate controller enabled (ACE) insulin pump and a separate 510(k) application for its SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC).

"We understand how meaningful these advancements are, and we're working with urgency to bring enhanced CGM options to our customers," said Que Dallara, EVP & president, Medtronic Diabetes. "This collaboration with Abbott marks an important step forward in providing innovative solutions and more choice for our customers."

This milestone follows the announcement last August that the companies will collaborate on an integrated system based on Abbott's most advanced CGM platform. Abbott will supply Medtronic with a CGM that will work exclusively with Medtronic smart dosing devices and software across both automated insulin delivery and smart multiple daily injections systems. These systems, including the Abbott CGM, will be sold exclusively by Medtronic.

More details will be shared when FDA clearance is secured.

About the Diabetes Business at Medtronic ( www.medtronicdiabetes.com )
Medtronic Diabetes is on a mission to alleviate the burden of diabetes by empowering individuals to live life on their terms, with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .

Any forward-looking statements, including, but not limited to, statements regarding the partnership between Medtronic and Abbott, strategic and other potential benefits of the partnership, Abbott's products and product candidates, and other statements about Medtronic managements' future expectations, beliefs, goals, plans or prospects, are subject to risks and uncertainties including, but not limited to, the ability to obtain regulatory approvals, and other risks and uncertainties such as those described in Medtronic's reports and other filings with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. Medtronic cautions investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and Medtronic undertakes no obligation to update or revise any of these statements except to the extent required by law.

Contacts:
Janet Cho
Public Relations
+1-818-403-7028

Ryan Weispfenning
Investor Relations
+1-763-505-4626

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-advances-abbott-cgm-partnership-with-fda-submission-of-interoperable-insulin-pump-302437337.html

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Orchestra BioMed Announces AVIM Therapy-Focused Satellite Symposium at HRS 2025 Annual Meeting

Orchestra BioMed Announces AVIM Therapy-Focused Satellite Symposium at HRS 2025 Annual Meeting

  • FDA recently granted Breakthrough Device Designation to AVIM therapy for use in patients with uncontrolled hypertension at increased cardiovascular risk
  • HRS Satellite Symposium will feature leading experts in electrophysiology, hypertension management and heart failure
  • Presentations will detail clinical results from prior studies demonstrating AVIM therapy's ability to immediately, substantially and persistently reduce systolic blood pressure, as well as improve cardiac function
  • Symposium will also feature presentation on the BACKBEAT global pivotal study Orchestra BioMed is currently enrolling in strategic collaboration with Medtronic, plc (NYSE: MDT)

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, "Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced it will host an industry-sponsored satellite symposium at the Heart Rhythm Society ("HRS") 2025 Annual Meeting, taking place April 24–27, 2025, in San Diego, California featuring recent advancements in the Company's atrioventricular interval modulation ("AVIM") therapy program. The April 25 th 6:45 am PT symposium titled " The Future of Cardiac Pacing: Unlocking the Potential of Atrioventricular Interval Modulation (AVIM) Therapy " will convene leading electrophysiologists, hypertension and heart failure specialists to discuss the unmet need in hypertension, AVIM therapy mechanism of action, and growing body of clinical evidence supporting this novel therapy for the treatment of patients with uncontrolled hypertension who have increased cardiovascular risk with or without an indication for a pacemaker.

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Orchestra BioMed Receives FDA Breakthrough Device Designation for AVIM Therapy

Orchestra BioMed Receives FDA Breakthrough Device Designation for AVIM Therapy

  • Breakthrough Device Designation ("BDD") applies to an estimated U.S. population of over 7.7 million patients with uncontrolled hypertension and increased cardiovascular risk
  • BDD also encompasses pacemaker-indicated patients with uncontrolled hypertension who are the focus of the BACKBEAT global pivotal study Orchestra BioMed is currently enrolling in strategic collaboration with Medtronic, plc (NYSE: MDT)
  • BDD status provides accelerated FDA engagement and reviews for AVIM therapy; it also supports potential pathways to secure higher reimbursement for AVIM-enabled devices in the future

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) ("Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Device Designation ("BDD") for atrioventricular interval modulation ("AVIM") therapy.

Specifically, the BDD is for an implantable system (i.e., a pacemaker) to deliver AVIM therapy using conduction system pacing to reduce blood pressure in patients with increased ten-year atherosclerotic cardiovascular disease ("ASCVD") risk, preserved left ventricular systolic function, and uncontrolled hypertension, despite the use of anti-hypertensive medications or in patients who may have intolerance to anti-hypertensive medications. Orchestra BioMed estimates that there are over 7.7 million patients in the U.S. that meet the criteria for the BDD for AVIM therapy. AVIM therapy is currently being evaluated under an FDA investigational device exemption ("IDE") in the BACKBEAT global pivotal study which is being conducted by Orchestra BioMed in collaboration with Medtronic. The BACKBEAT pivotal study is enrolling pacemaker-indicated patients with uncontrolled hypertension despite the use of anti-hypertensive medication, a key subpopulation under the BDD for which Orchestra BioMed believes AVIM therapy may offer optimal clinical benefit.

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