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Orthofix Medical Inc

For the period ended Jun 30, 2024. Filed Aug 6, 2024.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2024 · Filed Aug 6, 2024

OFIX$7.87-11.8%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2024-03-31; filed 2024-05-07.

0000950170-24-053966

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2024-06-30; filed 2024-08-06.

0000950170-24-091200

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 109 previous paragraphs and 149 current paragraphs.

55 unchanged; 38 reworded; 38 added; 16 removed; 0 previous and 18 current paragraphs rearranged.

Tables are not compared: 12 previous and 12 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (38)

Current report

Significant improvement in cash usage, paving the way for earlier than expected positive free cash flow for the second half of 2024

Current report

Announced appointments of four new executive team members, further strengthening the breadth and depth of the Company's leadership team

Current report

Net sales of $168.0 million, an increase of $10.1 million or 6.4%

Current report

Net sales of $329.3 million, an increase of $22.1 million or 7.2%

Current report

Net sales of $30.6 million, an increase of $1.5 million or 5.3%

Current report

International growth of $1.3 million, or 5.9% on a constant currency basis, primarily driven by recent product launches in Europe

Current report

Net sales of $57.9 million, an increase of $2.9 million or 5.2%

Current report

International growth of 1.9% on a constant currency basis, driven by recent product launches in Europe and offset by the timing of certain stocking distributor orders

Current report

Increase of $2.1 million driven by a reduction in certain inventory-related charges, primarily due to rationalization decisions made in the prior year related to the Merger

Current report

Increase of $2.8 million driven by a reduction in certain inventory-related charges, primarily due to rationalization decisions made in the prior year related to the Merger

Current report

Partially offset by a decrease of $2.9 million in other compensation expenses, including share-based compensation, primarily due to the realization of synergies following the Merger

Current report

Partially offset by a decrease of $2.6 million in other compensation expenses, including share-based compensation, primarily due to the realization of synergies following the Merger

Current report

Reduction in general and administrative expenses by the realization of Merger-related synergies, primarily from headcount

Current report

Decrease of $0.8 million driven by a favorable change in litigation and investigation related costs, including the release of a $2.5 million accrual in the second quarter of 2024

Current report

Reduction in general and administrative expenses by the realization of Merger-related synergies, primarily from headcount

Current report

Further offset by an increase of $1.1 million driven by an unfavorable change in litigation and investigation related costs

Current report

Partially offset by an increase in product development and clinical expenses

Current report

Partially offset by an increase in product development and clinical expenses

Current report

Acquisition-related amortization and remeasurement increased $4.1 million

Current report

Partially offset by a decrease of $0.3 million in amortization expense of intangible assets acquired in the Merger

Current report

Acquisition-related amortization and remeasurement increased $5.3 million

Current report

Partially offset by a decrease of $0.2 million in amortization expense of intangible assets acquired in the Merger

Current report

Decrease of $0.2 million of interest income resulting from the conversion of the convertible loan with Neo Medical into preferred equity securities in the second quarter of 2024

Current report

Decrease of $1.4 million associated with the impairment of certain investments measured at fair value

Current report

Decrease of $0.3 million of interest income resulting from the conversion of the convertible loan with Neo Medical into preferred equity securities in the second quarter of 2024

Current report

Decrease of $1.4 million associated with the impairment of certain investments measured at fair value

Current report

The decrease in tax expense compared to the prior year period is primarily due to withholding tax of $0.6 million that did not recur in the same period in 2024

Current report

The decrease in tax expense compared to the prior year period is partially attributable to amortization expense on long lived intangible assets offset by withholding tax in the prior year of $0.6 million that did not recur in 2024

Current report

Decrease of $2.1 million in debt issuance costs associated with the Financing Agreement with Blue Torch Financing LLC

Current report

Further offset by an increase in net proceeds of $0.2 million from the issuance of common shares and from the payment of a contingent consideration milestone of $0.9 million in the prior year
Removed paragraphs (16)

Previous report

First quarter net loss of $36 million; Non-GAAP adjusted EBITDA of $8 million, an increase of $4.5 million, a 220 basis point expansion over prior year

Previous report

Net sales of $161.3 million, an increase of $12.1 million or 8.1%

Previous report

Net sales of $27.3 million, an increase of $1.3 million or 5.1%

Previous report

International sales were flat compared to prior year due to healthcare provider strikes in the UK and timing of certain stocking distributors' orders

Previous report

Acquisition-related amortization and remeasurement increased $1.3 million

Previous report

Offset by a decrease of $0.6 million attributable to an early termination prepayment penalty associated with the payoff of the assumed indebtedness of SeaSpine as of the close of the Merger recorded in 2023

Previous report

The Company has two reporting segments: Global Spine and Global Orthopedics. The primary metric used in managing the Company is adjusted earnings before interest, tax, depreciation, and amortization ("Adjusted EBITDA", a non-GAAP financial measure) (which is described further in Note 11 to the Notes to the Unaudited Condensed Consolidated Financial Statements contained herein).

Previous report

The following table presents adjusted EBITDA by segment and reconciles consolidated adjusted EBITDA to loss before income taxes:

Previous report

Partially offset by $1.5 million in debt issuance costs and other financing activities

Previous report

Adjusted EBITDA represents earnings before interest income (expense), income taxes, depreciation, and amortization and excludes the impact of share-based compensation, gains and losses related to changes in foreign exchange rates, charges related to the SeaSpine merger and other strategic investments, acquisition-related fair value adjustments, interest and gains and losses on investments, litigation and investigation costs, charges related to initial compliance with regulations set forth by the European Union Medical Device Regulation, and succession charges. Adjusted EBITDA is the primary metric used by our Chief Operating Decision Maker in managing the business.
Reworded paragraphs (38)

Previous wording

Notable financial metrics in the first quarter of 2024 and recent achievements include the following:

Current wording

Notable financial metrics in the second quarter of 2024 and recent achievements include the following:

Previous wording

Net sales of $188.6 million, an increase of 7.7% on a reported and 7.5% on a constant currency basis over prior year

Current wording

Second quarter 2024 net sales of $198.6 million, an increase of 6% on a reported and constant currency basis compared to second quarter 2023

Previous wording

Bone Growth Therapies net sales growth of 10.0%, marking five consecutive quarters with double-digit net sales increases

Current wording

Bone Growth Therapies net sales growth of 12% compared to second quarter 2023, marking six consecutive quarters with double-digit net sales increases

Previous wording

U.S. Spine Fixation net sales growth of 16%, driven by distribution expansion and further penetration in existing accounts

Current wording

U.S. Spine Fixation net sales growth of 12%, driven by distribution expansion and further penetration in existing accounts

Previous wording

Global Orthopedics net sales growth of 5% on a reported basis, primarily driven by U.S. Orthopedic net sales growth of 23%

Current wording

Global Orthopedics net sales growth of 5% on a reported basis and 6% on a constant currency basis compared to second quarter 2023

Previous wording

The following tables provide net sales by major product category by reporting segment:

Current wording

Our operations are managed through two reporting segments: Global Spine and Global Orthopedics. The following tables provide net sales by product category by reporting segment:

Previous wording

Bone Growth Therapies net sales increased $4.8 million, or 10.0%, largely driven by (i) an increase in gross order volumes resulting from our continued investment in our direct sales channel for both the spine and fracture markets and (ii) continued growth and adoption of our AccelStim, which is used in the healing of fresh and nonunion fractures

Current wording

Bone Growth Therapies net sales increased $6.5 million, or 12.3%, largely driven by (i) an increase in gross order volumes resulting from our continued investment in our direct sales channel for both the spine and fracture markets, (ii) capitalization of cross-selling opportunities, and (iii) continued growth and adoption of AccelStim, which is used in the healing of fresh and nonunion fractures

Previous wording

Spinal Implants, Biologics, and Enabling Technologies net sales increased $7.3 million, or 7.2%, primarily due to increased sales growth from new and existing high-volume distribution partners, particularly within Spinal Implants, which saw growth in each of our cervical, interbody, and thoracolumbar franchises

Current wording

Spinal Implants, Biologics, and Enabling Technologies net sales increased $3.6 million, or 3.4%, primarily due to increased sales growth from new and existing high-volume distribution partners, particularly within Spinal Implants and Biologics, which saw growth in each of our cervical, interbody, thoracolumbar, and demineralized bone matrices franchises

Previous wording

U.S. growth of $1.5 million or 22.9%, largely due to investments made in recent product launches, commercial execution within our sales channel, and from our comprehensive surgeon education program

Current wording

U.S. growth of $2.0 million, or 14.7%, largely due to investments made in recent product launches, commercial execution within our sales channel, and from our comprehensive surgeon education program

Previous wording

Increase of $0.3 million due to movement in foreign currency exchange rates, which had a favorable impact on net sales in 2024

Current wording

Increase of $0.1 million due to movement in foreign currency exchange rates, which had a favorable impact on net sales in 2024

Previous wording

Increase of $8.6 million driven by a reduction of amortization of the inventory fair value step-up recognized in the Merger, which is being amortized over the expected sales cycles of the acquired inventory

Current wording

Increase of $6.4 million driven by a reduction of amortization of the inventory fair value step-up recognized in the Merger, which is being amortized over the expected sales cycles of the acquired inventory

Previous wording

Increase of $3.4 million in variable compensation expenses, including commissions, largely resulting from changes in sales volume and sales mix; this increase was partially offset by realization of synergies achieved following the Merger

Current wording

Increase of $2.5 million in variable compensation expenses, including commissions, largely resulting from changes in sales volume and sales mix

Previous wording

Increase of $2.9 million in depreciation expense related to an increase in deployed instrumentation to support increased sales demand

Current wording

Increase of $1.4 million in depreciation expense related to an increase in deployed instrumentation to support increased sales demand

Previous wording

Decrease of $3.6 million in share-based compensation expense primarily due to accelerated vesting of certain equity-based awards as a result of the Merger recorded in 2023

Current wording

Decrease of $1.7 million in share-based compensation expense primarily due to accelerated vesting of certain equity-based awards as a result of the Merger recorded in 2023

Previous wording

Decrease in integration-related expenses of $16.2 million compared to prior year comprised professional and advisor fees and severance and retention costs. In addition, general and administrative expenses were further reduced by the realization of Merger-related synergies

Current wording

Decrease in integration-related expenses of $1.1 million compared to prior year comprised professional and advisor fees and severance and retention costs. In addition, general and administrative expenses were further reduced by the realization of Merger-related synergies

Previous wording

Partially offset by an increase of $2.2 million in succession charges as a result of recent changes in executive leadership positions

Current wording

Partially offset by an increase of $5.1 million in succession charges as a result of recent changes in executive leadership positions

Previous wording

Decrease of $2.3 million in costs to comply with the European Union Medical Device Regulations

Current wording

Decrease of $1.7 million in costs to comply with the European Union Medical Device Regulations

Previous wording

Decrease of $1.4 million related to merger and integration-related expenses, primarily related to severance and retention costs. In addition, research and development expenses were further reduced by the realization of Merger-related synergies. This was partially offset by an increase in our clinical spend related to the ongoing clinical study for the M6-C artificial disc

Current wording

Decrease of $0.4 million related to merger and integration-related expenses, primarily related to severance and retention costs. In addition, research and development expenses were further reduced by the realization of Merger-related synergies.

Previous wording

Increase of $1.2 million recognized in 2024 associated with the remeasurement of a contingent consideration obligation with Lattus Spine LLC assumed in the Merger

Current wording

Increase of $4.4M recognized in 2024 associated with the remeasurement of a contingent consideration obligation with Lattus Spine LLC assumed in the Merger

Previous wording

Increase of $3.6 million attributable to an increase in outstanding indebtedness as part of our Financing Agreement in 2024 compared to prior year

Current wording

Increase of $3.5 million attributable to an increase in outstanding indebtedness as part of our Financing Agreement in 2024 compared to prior year

Previous wording

Decrease of $2.2 million associated with changes in foreign currency exchange rates, as we recorded a non-cash remeasurement loss of ($1.6 million) in 2024 compared to a gain of $0.6 million in 2023

Current wording

Decrease of $3.3 million associated with changes in foreign currency exchange rates, as we recorded a non-cash remeasurement loss of ($2.4 million) in 2024 compared to a gain of $0.9 million in 2023

Previous wording

Partially offset by a $0.3 million increase associated with the reversal of expected credit loss recognized on the Neo Medical convertible loan

Current wording

Partially offset by a $0.3 million increase associated with the reversal of a previously recognized estimate of expected credit losses recognized on the Neo Medical convertible loan

Previous wording

The primary factor affecting our tax expense for the first quarter of 2024 was tax amortization on certain acquired intangibles

Current wording

The primary factor affecting our tax expense through the second quarter of 2024 compared to the prior year period was tax amortization on certain acquired intangibles and financial statement losses not benefitted

Previous wording

The increase in tax expense compared to the prior year period was primarily a result of changes in valuation allowances and tax amortization on certain acquired intangibles

Current wording

The primary factor affecting our tax expense through the second quarter of 2024 compared to the prior year period was tax amortization on certain acquired intangibles and financial statement losses not benefitted

Previous wording

Cash, cash equivalents, and restricted cash at March 31, 2024, totaled $29.5 million compared to $37.8 million at December 31, 2023. The following table presents the net change in cash, cash equivalents, and restricted cash for the three months ended March 31, 2024, and 2023, respectively:

Current wording

Cash, cash equivalents, and restricted cash at June 30, 2024, totaled $28.9 million compared to $37.8 million at December 31, 2023. The following table presents the net change in cash, cash equivalents, and restricted cash for the six months ended June 30, 2024, and 2023, respectively:

Previous wording

Cash flows from operating activities increased $15.4 million

Current wording

Cash flows from operating activities increased $29.9 million

Previous wording

Unfavorable change of $7.7 million associated with non-cash gains and losses, largely related to amortization of the inventory fair value step up recognized in the Merger, share-based compensation expense, depreciation and amortization expenses, changes in the fair value of contingent consideration, provisions for expected credit losses, and inventory reserve expenses

Current wording

Unfavorable change of $6.5 million associated with non-cash gains and losses, such as for the amortization of the inventory fair value step-up recognized in the Merger, inventory reserve expenses, remeasurement of contingent consideration obligations, and share-based compensation expense

Previous wording

Unfavorable change of $1.8 million relating to changes in working capital accounts, primarily attributable to changes in inventories, accounts receivable, and other current liabilities

Current wording

Favorable change of $5.6 million relating to changes in working capital accounts, primarily attributable to changes in inventories, trade accounts payable, and other current assets

Previous wording

Two of our primary working capital accounts are accounts receivable and inventory. Days sales in receivables were 61 days at March 31, 2024, compared to 58 days at March 31, 2023 (calculated using first quarter net sales and ending accounts receivable). Inventory turns improved to 1.2 times as of March 31, 2024 compared to 0.7 times as of March 31, 2023.

Current wording

Two of our primary working capital accounts are accounts receivable and inventory. Days sales in receivables were 57 days at June 30, 2024, compared to 55 days at June 30, 2023 (calculated using second quarter net sales and ending accounts receivable). Inventory turns improved to 1.2 times as of June 30, 2024 compared to 0.9 times as of June 30, 2023 (calculated using trailing twelve month cost of goods sold and ending net inventories).

Previous wording

Cash flows from investing activities decreased $28.0 million

Current wording

Cash flows from investing activities decreased $24.8 million

Previous wording

Partially offset by a decrease in spend of $1.0 million in capital expenditures and $0.5 million in other investing activities in 2024 compared to 2023

Current wording

Partially offset by a decrease in spend of $4.1 million in capital expenditures and $0.5 million in other investing activities

Previous wording

Cash flows from financing activities increased $5.5 million

Current wording

Cash flows from financing activities decreased $0.1 million

Previous wording

Increase of $6.9 million associated with net borrowing activities related to our credit facilities and from our assumption of SeaSpine's outstanding indebtedness at the time of the Merger

Current wording

Offset by an increase of $0.9 million associated with net borrowing activities related to our credit facilities and from our assumption of SeaSpine's outstanding indebtedness at the time of the Merger

Previous wording

Under the terms of a contingent consideration obligation in a purchase agreement assumed in the Merger, we may be required to make installment payments at certain dates based on future net sales of certain products (the "Lateral Products"). The estimated fair value of the contingent consideration arrangement as of March 31, 2024, was $9.7 million; however, the actual amount ultimately paid could be higher or lower than the estimated fair value of the contingent consideration. As of March 31, 2024, we classified the remaining contingent consideration liability within other long-term liabilities. For additional discussion of this matter, see Note 7 of the Notes to the Unaudited Condensed Consolidated Financial Statements.

Current wording

Under the terms of a contingent consideration obligation in a purchase agreement assumed in the Merger, we may be required to make installment payments at certain dates based on future net sales of certain products (the "Lateral Products"). The estimated fair value of the contingent consideration arrangement as of June 30, 2024, was $12.7 million; however, the actual amount ultimately paid could be higher or lower than the estimated fair value of the contingent consideration. As of June 30, 2024, we classified the remaining contingent consideration liability of $5.9 million and $6.8 million within other current liabilities and other long-term liabilities, respectively. For additional discussion of this matter, see Note 7 of the Notes to the Unaudited Condensed Consolidated Financial Statements.

Previous wording

In May 2022, we achieved FDA approval pertaining to the acquired technology, triggering a contingent consideration milestone obligation of $3.5 million. Of this amount, $1.5 million was paid in 2022, $1.0 million was paid in May 2023, and $1.0 million was accrued within other current liabilities as of March 31, 2024.

Current wording

In May 2022, we achieved FDA approval pertaining to the acquired technology, triggering a contingent consideration milestone obligation of $3.5 million. Of this amount, $1.5 million was paid in 2022, $1.0 million was paid in May 2023, and $1.0 million was paid subsequent to the reporting period in July 2024.
Rearranged current paragraphs (18)

Current report — wording carried from elsewhere

Bone Growth Therapies net sales increased $11.2 million or 11.2%, driven by (i) an increase in gross order volumes resulting from our continued investment in our direct sales channel for both the spine and fracture markets, (ii) capitalization of cross-selling opportunities, and (iii) continued growth and adoption of AccelStim

Current report — wording carried from elsewhere

Spinal Implants, Biologics, and Enabling Technologies net sales increased $10.9 million, or 5.3%, primarily due to increased sales growth from new and existing high-volume distribution partners, particularly within Spinal Implants and Biologics, which saw growth in each of our cervical, interbody, thoracolumbar, and demineralized bone matrices franchises

Current report — wording carried from elsewhere

U.S. growth of $0.5 million, or 7.2%, largely due to investments made in recent product launches and commercial execution within our sales channel and from our comprehensive surgeon education program

Current report — wording carried from elsewhere

Partially offset by a decrease of $0.3 million due to movement in foreign currency exchange rates, which had an unfavorable impact on net sales in the second quarter of 2024

Current report — wording carried from elsewhere

Increase in gross profit driven primarily by net sales growth across all principal product categories

Current report — wording carried from elsewhere

Increase of $15.0 million driven by a reduction of amortization of the inventory fair value step-up recognized in the Merger, which is being amortized over the expected sales cycles of the acquired inventory

Current report — wording carried from elsewhere

Increase of $5.3 million in variable compensation expenses, including commissions, largely resulting from changes in sales volume and sales mix

Current report — wording carried from elsewhere

Increase of $4.3 million in depreciation expense related to an increase in deployed instrumentation to support increased sales demand

Current report — wording carried from elsewhere

Decrease in integration-related expenses of $17.2 million compared to prior year comprised professional and advisor fees and severance and retention costs.

Current report — wording carried from elsewhere

Decrease of $5.3 million in share-based compensation expense primarily due to accelerated vesting of certain equity-based awards as a result of the Merger recorded in 2023

Current report — wording carried from elsewhere

Partially offset by an increase of $7.3 million in succession charges as a result of recent changes in executive leadership positions

Current report — wording carried from elsewhere

Decrease of $4.0 million in costs to comply with the European Union Medical Device Regulations

Current report — wording carried from elsewhere

Decrease of $1.8 million related to merger and integration-related expenses, primarily related to severance and retention costs. In addition, research and development expenses were further reduced by the realization of Merger-related synergies.

Current report — wording carried from elsewhere

Increase of $5.5M recognized in 2024 associated with the remeasurement of a contingent consideration obligation with Lattus Spine LLC assumed in the Merger

Current report — wording carried from elsewhere

Decrease of $1.1 million associated with changes in foreign currency exchange rates, as we recorded a non-cash remeasurement loss of ($0.9 million) in the second quarter of 2024 compared to a gain of $0.3 million in the second quarter of 2023

Current report — wording carried from elsewhere

Interest expense, net increased $6.9 million

Current report — wording carried from elsewhere

Increase of $6.7 million attributable to an increase in outstanding indebtedness as part of our Financing Agreement in 2024 compared to prior year

Current report — wording carried from elsewhere

Other income (expense), net decreased $4.4 million