What changed in this filing

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Item 2. Management’s Discussion and Analysis

2023-01-06 compared with 2022-10-11 · 101 added, 89 removed, 129 unchanged (60% of the section changed)

41 unchanged sentences

On August 30, 2022, the Company repaid all amounts outstanding under its then existing credit agreement and entered into a new Credit Agreement.

The new Credit Agreement provides for a $75.0 million Revolving Facility and a $30.0 million Delayed Draw Term Loan as of August 31, 2022, $25.0 million was drawn on the Revolving Facility and $25.0 million was drawn on the Delayed Draw Term Loan .

The new Credit Agreement provides for a $75.0 million Revolving Facility and a $30.0 million Delayed Draw Term Loan as of November 30, 2022, $25.0 million was drawn on the Revolving Facility and $25.0 million was drawn on the Delayed Draw Term Loan.

See Note 7 "Long-Term Debt" set forth in the Notes to the consolidated financial statements.

1 unchanged sentence

In evaluating the operating performance of our business, management focuses on company-wide and segment revenue and gross margin and company-wide operating income, earnings per share and cash flow from operations.

A summary of these key financial metrics for the three months ended August 31, 2022 compared to the three months ended August 31, 2021 are as follows:

Three months ended August 31, 2022:

A summary of these key financial metrics for the three and six months ended November 30, 2022 compared to the three and six months ended November 30, 2021 are as follows:

Three months ended November 30, 2022:

• Revenue increased by 9.1% to $85.4 million.

• Med Tech growth of 29.6% while Med Device declined 1.1%.

• Gross profit decreased 20 bps to 51.9%.

• Med Tech gross profit decreased 220 bps to 63.2% and Med Device gross profit decreased 70 bps to 47.5%.

• Med Tech growth of 29.7% and Med Device growth of 2.6%.

• Gross profit increased 100 bps to 52.8%.

• Med Tech gross profit decreased 290 bps to 63.7% and Med Device gross profit increased 130 bps to 48.4%.

• Net loss increased by $0.1 million to $8.5 million.

• Loss per share was consistent at a loss of $0.21.

Six months ended November 30, 2022:

• Revenue increased by 7.5% to $167.0 million.

• Med Tech growth of 29.7% and Med Device growth of 0.7%.

• Gross profit increased 30 bps to 52.3%.

• Med Tech gross profit decreased 250 bps to 63.5% and Med Device gross profit increased 20 bps to 47.9%.

• Net loss increased by $6.2 million to $21.5 million.

• Loss per share increased by $0.16 to a loss of $0.55.

Our Med Tech revenue, comprised of Auryon, the thrombus management platform and NanoKnife grew 29.6% in the first quarter of fiscal year 2023.

The growth in Auryon, the thrombus management platform and NanoKnife disposables was partially offset by decreased NanoKnife capital sales.

Our Med Device revenue declined 1.1% in the first quarter of fiscal year 2023 driven by the backlog in Vascular Access products and continued pressures from reductions in Oncology procedure volumes due to challenges resulting from the COVID-19 pandemic, a trend that may continue.

Our Med Tech revenue, comprised of Auryon, the thrombus management platform and NanoKnife, grew 29.7% in the second quarter of fiscal year 2023.

The growth in Auryon and NanoKnife capital and disposables was partially offset by decreased thrombus management platform sales.

Our Med Device revenue grew 2.6% in the second quarter of fiscal year 2023

driven by growth in Core, Dialysis, Ports and Microwave products, partially offset by the backlog in Vascular Access products and continued pressures from reductions in Oncology procedure volumes due to challenges resulting from the COVID-19 pandemic, a trend that may continue.

Results of Operations

For the three months ended August 31, 2022, the Company reported a net loss of $13.0 million, or a loss of $0.33 per diluted share, on net sales of $81.5 million, compared with a net loss of $7.0 million, or a loss of $0.18 per diluted share, on net sales of $77.0 million during the same quarter of the prior year.

For the three months ended November 30, 2022, the Company reported a net loss of $8.5 million, or a loss of $0.21 per diluted share, on net sales of $85.4 million, compared with a net loss of $8.4 million, or a loss of $0.21 per diluted share, on net sales of $78.3 million during the same quarter of the prior year.

For the six months ended November 30, 2022, the Company reported a net loss of $21.5 million, or a loss of $0.55 per diluted share, on net sales of $167.0 million, compared with a net loss of $15.3 million, or a loss of $0.39 per diluted share, on net sales of $155.3 million during the same quarter of the prior year.

Net sales - Net sales are derived from the sale of products and related freight charges, less discounts, rebates and returns.

Three Months Ended

(in thousands) Aug 31, 2022 Aug 31, 2021 % Change

Three Months Ended Six Months Ended

(in thousands) Nov 30, 2022 Nov 30, 2021 % Change Nov 30, 2022 Nov 30, 2021 % Change

Med Tech $ 24,502 $ 18,886 29.7% $ 47,318 $ 36,493 29.7%

1 unchanged sentence

Total $ 85,429 $ 78,280 9.1% $ 166,966 $ 155,251 7.5%

Three Months Ended

(in thousands) Aug 31, 2022 Aug 31, 2021 % Change

Three Months Ended Six Months Ended

(in thousands) Nov 30, 2022 Nov 30, 2021 % Change Nov 30, 2022 Nov 30, 2021 % Change

Net Sales by Geography

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Total $ 85,429 $ 78,280 9.1% $ 166,966 $ 155,251 7.5%

For the three months ended August 31, 2022, net sales increased $4.6 million to $81.5 million compared to the same period in the prior year.

At August 31, 2022, the Company had a backlog of $7.1 million, a decrease of $1.3 million from May 31, 2022.

The Med Tech segment net sales increased $5.2 million for the three months ended August 31, 2022 compared to the same period in the prior year period.

The change in sales from the prior year was primarily driven by:

• Increased Auryon sales of $2.9 million;

• Growth in the thrombus management platform of $2.4 million .

Increased sales in the mechanical thrombectomy platform of $2.3 million was driven by AngioVac and the launch of the AlphaVac product in the second quarter of fiscal year 2022;

• Decreased NanoKnife sales of $0.1 million, which was driven by decreased capital sales internationally.

This decrease was partially offset by a $0.3 million increase in disposable sales in the U.S.

and internationally.

The Med Device segment net sales decreased $0.6 million for the three months ended August 31, 2022 compared to the same period in the prior year period.

The change in sales from the prior year was primarily driven by:

• The backlog of $7.1 million at August 31, 2022, which primarily impacted sales of Core and Vascular Access products;

• Decreased sales of Venous, Midlines, PICCs, Ports, Radio Frequency A blation and BioSentry of $0.5 million, $0.4 million, $0.6 million, $0.6 million, $0.4 million and $0.3 million, respectively.

These decreases were partially offset by increased Dialysis (despite the impact of the backlog), Core and Microwave sales of $1.2 million, $0.9 million and $0.3 million, respectively.

Three Months Ended

(in thousands) Aug 31, 2022 Aug 31, 2021 % Change

For the three months ended November 30, 2022, net sales increased $7.1 million to $85.4 million compared to the same period in the prior year.

For the six months ended November 30, 2022, net sales increased $11.7 million to $167.0 million compared to the same period in the prior year.

At November 30, 2022, the Company had a backlog of $5.0 million, a decrease of $2.1 million from August 31, 2022.

The Med Tec h segment net sales increased $5.6 million and $10.8 million fo r the three and six months ended November 30, 2022 compared to the same periods in the prior year, respectively.

The change in sales for both periods was primarily driven by:

• Increased Auryon sales of $3.8 million and $6.7 million compared to the same periods in the prior year, respectively;

• Growth in the thrombus management platform of $2.4 million for the six months ended November 30, 2022 compared to the same period in the prior year, while the thrombus management platform was flat for the three months ended November 30, 2022 compared to the same period in the prior year.

Increased sales in the mechanical thrombectomy platform of $2.2 million f or the six months ended November 30, 2022 compared to the same period in the prior year, was driven by the AlphaVac product;

• Increased NanoKnife sales of $1.8 million and $1.7 million compared to the same periods in the prior year, respectively , which was primarily driven by increased probe sales domestically and internationally.

The Me d Device segment net sales increased $1.5 million and $0.9 million for the three and six months ended November 30, 2022 compared to the same periods in the prior year, respectively.

The change in sales for both periods was primarily driven by:

• The backlog of $5.0 million at November 30, 2022, which primarily impacted sales of Core and Vascular Access products;

• Increased sales of Core, Dialysis and Ports, despite the impact of the backlog, along with increased Microwave sales for the three months ended November 30, 2022 compared to the same period in the prior year of $1.9 million, $1.6

million, $0.6 million and $0.3 million, respectively.

These increases were partially offset by decreased Venous, PICCs and other Oncology sales for the three months ended November 30, 2022 compared to the same period in the prior year of $1.2 million, $0.8 million and $0.7 million, respectively;

• Increased sales of Core and Dialysis, despite the impact of the backlog, along with increased Microwave sales for the six months ended November 30, 2022 compared to the same period in the prior year of $2.8 million, $2.8 million and $0.6 million, respectively.

These increases were partially offset by decreased Venous, PICCs, Midlines and other Oncology and Vascular Access sales for the six months ended November 30, 2022 compared to the same period in the prior year of $1.7 million, $1.4 million, $0.4 million and $1.5 million, respectively.

Three Months Ended Six Months Ended

(in thousands) Nov 30, 2022 Nov 30, 2021 % Change Nov 30, 2022 Nov 30, 2021 $ Change

Med Tech $ 15,614 $ 12,578 24.1 % $ 30,043 $ 24,095 24.7 %

5 unchanged sentences

Gross profit - Gross profit consists of net sales less the cost of goods sold, which includes the costs of materials, products purchased from third parties and sold by us, manufacturing personnel, royalties, freight, business insurance, depreciation of property and equipment and other manufacturing overhead, exclusive of intangible amortization.

Total Company gross profit increased by $2.2 million for the three months ended August 31, 2022 compared to the same period in the prior year.

The change from the prior year was primarily driven by:

• Sales volume, which positively impacted gross profit by $2.7 million;

• Net productivity, which positively impacted gross profit by $2.0 million;

• Pricing and mix, which positively impacted gross profit by $0.4 million;

• Inflationary costs on raw materials, labor shortages and freight costs, which negatively impacted gross profit by $2.2 million;

• Depreciation on placement units of $0.7 million.

The Med Tech segment gross profit increased by $2.9 million for the three months ended August 31, 2022 compared to the same period in the prior year.

The change from the prior year was primarily driven by:

• Sales volume, which positively impacted gross profit by $3.9 million;

• Net productivity, which positively impacted gross profit by $0.7 million;

• Pricing pressures and mix, which negatively impacted gross profit by $1.2 million;

• Inflationary costs on raw materials, labor shortages and freight costs, which negatively impacted gross profit by $0.2 million;

• Depreciation on Auryon and NanoKnife placement units of $0.4 million.

The Med Device segment gross profit decreased by $0.7 million for the three months ended August 31, 2022 compared to the same period in the prior year.

The change from the prior year was primarily driven by:

• Net productivity, which positively impacted gross profit by $1.5 million was driven by the additional manufacturing capacity with the Costa Rica plant;

• Price and mix, which positively impacted gross profit by $0.3 million;

• Sales volume, which negatively impacted gross profit by $0.4 million;

• Inflationary costs on raw materials, labor shortages and freight costs, which negatively impacted gross profit by $2.0 million.

Total Company gross profit increased by $4.5 million and $6.7 million for the three months and six months ended November 30, 2022 compared to the same periods in the prior year.

The change for both periods was primarily driven by:

• Sales volume, which positively impacted gross profit by $4.2 million and $6.9 million, respectively;

• Production volume, mix and other incentives which positively impacted gross profit by $2.8 million and $5.5 million, respectively;

• Pricing, which negatively impacted gross profit by $1.9 million and $3.3 million, respectively;

• Inflationary costs on raw materials, labor shortages and freight costs, which negatively impacted gross profit by $1.1 million for the six months ended November 30, 2022;

• Depreciation on placement units of $0.5 million and $1.2 million, respectively.

The Med Tech segment gross profit increased by $3.0 million and $5.9 million for the three and six months ended November 30, 2022 compared to the same periods in the prior year.

The change for both periods was primarily driven by:

• Sales volume, which positively impacted gross profit by $4.6 million and $8.6 million, respectively;

• Production volume, overhead, manufacturing and other incentives which positively impacted gross profit by $1.1 million and $1.9 million, respectively;

• Pricing pressures and mix, which negatively impacted gross profit by $2.4 million and $3.8 million, respectively;

• Depreciation on placement units of $0.3 million and $0.7 million, respectively.

The Med Device segment gross profit increased by $1.5 million and $0.7 million for the three and six months ended November 30, 2022 compared to the same periods in the prior year.

The change for both periods was primarily driven by:

• Sales volume, which positively impacted gross profit by $0.5 million and $0.1 million, respectively;

• Production volume, manufacturing and other incentives which positively impacted gross profit by $2.5 million and $3.7 million, respectively;

• Pricing pressures and mix, which negatively impacted gross profit by $0.5 million and $0.8 million, respectively;

• Inflationary costs on raw materials, labor shortages and freight costs, which negatively impacted gross profit by $1.0 and $2.1 million, respectively;

• Depreciation on placement units of $0.1 million and $0.2 million, respectively.

Operating Expenses, and Other Income (expense)

Three Months Ended

(in thousands) Aug 31, 2022 Aug 31, 2021 % Change

Three Months Ended Six Months Ended

(in thousands) Nov 30, 2022 Nov 30, 2021 % Change Nov 30, 2022 Nov 30, 2021 % Change

Research and development $ 6,838 $ 8,199 (16.6) % $ 15,171 $ 15,593 (2.7) %

5 unchanged sentences

Research and development expense - Research and development (“R&D”) expense includes internal and external costs to develop new products, enhance existing products, validate new and enhanced products, and manage clinical, regulatory and medical affairs.

R&D expense increased $0.9 million for the three months ended August 31, 2022 compared to the same period in the prior year.

The change from the prior year was primarily driven by:

• The timing of certain projects and clinical spend associated with the ongoing clinical trials, which increased R&D expense by $0.9 million.

R& D expense decreased $1.4 million and $0.4 million for t he three and six months ended November 30, 2022 compared to the same periods in the prior year, respectively.

The change for both periods was primarily driven by:

• The timing of certain projects and clinical spend associated with the ongoing clinical trials, which decreased R&D expense by $1.4 million and $0.5 million, respectively.

Sales and marketing expense - Sales and marketing (“S&M”) expense consists primarily of salaries, commissions, travel and related business expenses, attendance at medical society meetings, product promotions and marketing activities.

S&M expense increased $2.1 million for the three months ended August 31, 2022 compared to the same period in the prior year.

The change from the prior year was primarily driven by:

• Additional headcount from the build-out of the Auryon and mechanical thrombectomy sales and marketing teams, which increased compensation and benefits expense by $1.2 million;

• Travel, meeting and tradeshow expenses, which increased $1.2 million and was partially offset by decreased facilities and depreciation expense of $0.2 million.

S&M expense increased $2.4 million and $4.5 million for t he three and six months ended November 30, 2022 compared to the same periods in the prior year, respectively.

The change for both periods was primarily driven by:

• Additional headcount from the build-out of the Auryon and mechanical thrombectomy sales and marketing teams, which increased compensation and benefits expense by $1.2 million and $2.5 million, respectively;

• Travel, meeting and tradeshow expenses, which increased $1.3 million and $2.7 million, respectively, and was partially offset by decreased facilities, depreciation and other expenses of $0.3 million and $0.6 million, respectively.

General and administrative expense - General and administrative (“G&A”) expense includes executive management, finance, information technology, human resources, business development, legal, and the administrative and professional costs associated with those activities.

G&A expense increased $1.2 million for the three months ended August 31, 2022 compared to the same period in the prior year.

The change from the prior year was primarily driven by:

• Compensation and benefits and travel expenses, which increased $0.6 million and $0.2 million, respectively;

• Other outside consultant spend for legal and IT, which increased $0.4 million.

Three Months Ended

(in thousands) Aug 31, 2022 Aug 31, 2021 $ Change

G&A e xpense increased $1.2 million and $2.3 million for th e three and six months ended November 30, 2022 compared to the same periods in the prior year, respectively.

The change for both periods was primarily driven by:

• Compensation and benefits and travel expenses, which increased $0.6 million for the six months ended November 30, 2022 and decreased $0.2 million for the three months ended November 30, 2022;

• Other outside consultant spend for legal and IT which increased $1.2 million and $1.6 million, respectively.

Three Months Ended Six Months Ended

(in thousands) Nov 30, 2022 Nov 30, 2021 $ Change Nov 30, 2022 Nov 30, 2021 $ Change

Amortization of intangibles $ 4,808 $ 4,889 $ (81) $ 9,645 $ 9,710 $ (65)

5 unchanged sentences

Change in fair value of contingent consideration - Represents changes in contingent consideration driven by changes to estimated future payments on earn-out liabilities created through acquisitions and amortization of present value discounts on long-term contingent consideration.

• The change in the fair value for the three months ended August 31, 2022 is related to the Eximo contingent consideration.

• The change in the fair value for the three and six months ended November 30, 2022 is related to the Eximo contingent consideration and the increased probability of achieving the revenue milestones.

Acquisition, restructuring and other items, net - Represents costs associated with mergers and acquisitions, restructuring expenses, legal costs that are related to litigation that is not in the ordinary course of business, legal settlements and other one-time items.

Acquisition, restructuring and other items, net, increased by $3.1 million for the three months ended August 31, 2022, compared to the same period in the prior year.

The change from the prior year was primarily driven by:

Acquisition, restructuring and other item s, net, increased by $0.8 million and $3.9 million for the three and six months ended November 30, 2022, compared to the same periods in the prior year, respectively.

The change for both periods was primarily driven by:

• Manufacturing relocation expense related to the move of certain manufacturing lines to Costa Rica, which increased $0.5 million and $0.7 million, respectively;

• Legal expense, re lated to litigation that is outside of the normal course of business, which increased $0.4 million and $0.1 million, respectively;

• Other expenses (mainly severance associated with organizational changes), which decreased $0.3 million for the six months ended November 30, 2022;

• The payment to the Israeli Innovation Authority of $3.5 million related to grant funds that were provided to Eximo to develop the Auryon laser prior to the acquisition in the second quarter of fiscal year 2020.

These grant funds were fully repaid in the first quarter of fiscal year 2023 to satisfy the obligation which was otherwise being paid as a royalty based on a percentage of sales.

• Manufacturing relocation expense related to the move of certain manufacturing lines to Costa Rica of $0.1 million;

• Legal expense, re lated to litigation that is outside of the normal course of business, which decreased $0.2 million;

• Other expenses (mainly severance associated with organizational changes), which decreased $0.3 million.

Other expense, net - Other expenses include interest expense, foreign currency impacts, bank fees, and amortization of deferred financing costs.

• Other expense, net remained consistent with the prior year.

• The change in other expe nse of $0.8 million for both the three and six months ended November 30, 2022 compared to the same periods in the prior year, is primarily due to increased interest expense of $0.5 million and $0.7 million, respectively and unrealized foreign currency fluctuations of $0.3 million and $0.1 million, respectively.

Income Tax Benefit

Three Months Ended

(in thousands) Aug 31, 2022 Aug 31, 2021

Three Months Ended Six Months Ended

(in thousands) Nov 30, 2022 Nov 30, 2021 Nov 30, 2022 Nov 30, 2021

Income tax benefit $ (0.6) $ (0.5) $ (1.4) $ (2.1)

Effective tax rate including discrete items 6.2 % 5.8 % 6.2 % 12.3 %

Our effective tax rate including discrete items for the three-month periods ended August 31, 2022 and 2021 was 6.2% and 19.0%, respectively.

Our effective tax rate including discrete items for the three months ended November 30, 2022 and 2021 was 6.2% and 5.8%, respectively.

Our effective tax rate including discrete items for the six months ended November 30, 2022 and 2021 was 6.2% and 12.3%, respectively.

In fiscal year 2023, the Company’s effective tax rate differs from the U.S.

4 unchanged sentences

We are closely monitoring receivables and payables.

Our cash and cash equivalents totaled $24.6 million as of August 31, 2022, compared with $28.8 million as of May 31, 2022.

As of August 31, 2022 and May 31, 2022, total debt outstanding related to the Credit Agreement was $50.0 million ($25.0 million on the Revolving Facility and $25.0 million on the Delayed Draw Term Loan) and $25.0 million, respectively.

The fair value of contingent consideration liability as of August 31, 2022 and May 31, 2022, was $17.2 million and $16.9 million, respectively.

Our cash and cash equivalents totaled $29.9 million as of November 30, 2022, compared with $28.8 million as of May 31, 2022.

As of November 30, 2022 and May 31, 2022, total debt outstanding related to the Credit Agreement was $50.0 million ($25.0 million on the Revolving Facility and $25.0 million on the Delayed Draw Term Loan) and $25.0 million, respectively.

The fair value of contingent consideration liability as of November 30, 2022 and May 31, 2022, was $18.8 million and $16.9 million, respectively.

The table below summarizes our cash flows:

Three Months Ended

(in thousands) Aug 31, 2022 Aug 31, 2021

Six Months Ended

(in thousands) Nov 30, 2022 Nov 30, 2021

Cash provided by (used in):

4 unchanged sentences

Net change in cash and cash equivalents $ 1,032 $ (13,870)

During the quarters ended August 31, 2022 and 2021, cash flows consisted of the following:

During the quarters ended November 30, 2022 and 2021, cash flows consisted of the following:

Cash used in operating activities

Three months ended August 31, 2022 and 2021:

Six months ended November 30, 2022 and 2021:

• Net loss of $21.5 million and $15.3 million, respectively, plus the non-cash items, primarily driven by depreciation and amortization and stock based compensation, along with the changes in working capital below, contributed to cash used in operations of $17.2 million and $7.0 million, respectively, for these periods.

• For the period ended August 31, 2022, working capital was unfavorably impacted by decreased accounts payable, accrued liabilities and other liabilities of $9.0 million, mainly driven by the payment of annual incentive compensation in the first fiscal quarter, along with increased accounts rec eivable, inventory and prepaid expenses of $1.4 million, $6.2 million and $5.7 million, respectively.

• For the period ended August 31, 2021, working capital was unfavorably impacted by decreased accounts payable, accrued liabilities and other liabilities of $6.3 million, mainly driven by the payment of annual incentive compensation in the first fiscal quarter, along with increased inventory of $0.7 million.

• For the period ended November 30, 2022, working capital was unfavorably impacted by decreased accounts payable, accrued liabilities and other liabilities of $2.8 million, along with increased accounts rec eivable, inventory and prepaid expenses of $1.0 million, $11.8 million and $3.9 million, respectively.

• For the period ended November 30, 2021, working capital was unfavorably impacted by decreased accounts payable, accrued liabilities and other liabilities of $4.5 million, along with increased receivables of $2.9 million.

Cash used in investing activities

Three months ended August 31, 2022 and 2021:

Six months ended November 30, 2022 and 2021:

• $2.1 million and $2.2 million, respectively, of cash was used for fixed asset additions;

3 unchanged sentences

Cash provided by financing activities

Three months ended August 31, 2022 and 2021:

Six months ended November 30, 2022 and 2021:

• $70.0 million in proceeds on long-term debt less the repayment of $45.0 million associated with the new Credit Agreement in the first quarter of fiscal year 2023.

11 unchanged sentences

The amount that we can borrow under our Credit Agreement is directly based on our leverage ratio.

The interest rate at August 31, 2022 applicable to each was 4.06%.

The Company was in compliance with the Credit Agreement covenants as of August 31, 2022.

The interest rate at November 30, 2022 applicable to each was 5.59%.

The Company was in compliance with the Credit Agreement covenants as of November 30, 2022.

In the first quarter of fiscal year 2023 and in connection with the new Credit Agreement, the Company drew $25.0 million on the Revolving Facility.

6 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis