RTI SURGICAL HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share data)
1.
|
Operations and Organization
|
RTI Surgical Holdings, Inc. and Subsidiaries (defined as the “Company” for matters occurring after March 8, 2019) is a global surgical implant company that designs, develops, manufactures and distributes biologic, metal and synthetic implants. The Company’s implants are used in orthopedic, spine, sports medicine, plastic surgery, trauma and other surgical procedures to repair and promote the natural healing of human bone and other human tissues and improve surgical outcomes. The Company manufactures metal and synthetic implants and processes donated human musculoskeletal and other tissue and bovine and porcine animal tissue in producing allograft and xenograft implants using its proprietary BIOCLEANSE®, TUTOPLAST® and CANCELLE® SP sterilization processes. The Company processes tissue at its facilities in Alachua, Florida and Neunkirchen, Germany and manufactures metal and synthetic implants in Marquette, Michigan and Greenville, North Carolina, respectively, and has a distribution and research center in Wurmlingen, Germany. The Company is accredited in the U.S. by the American Association of Tissue Banks and the Company is a member of AdvaMed. The Company’s implants are distributed directly to hospitals and free-standing surgery centers throughout the U.S. and in over 50 countries worldwide with the support of both its and third-party representatives as well as through larger purchasing companies.
The accompanying unaudited condensed consolidated financial statements include all adjustments, consisting of normal recurring accruals, which the Company considers necessary for a fair presentation of the results of operations for the periods shown. The condensed consolidated financial statements have been prepared in accordance with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X, and, therefore, do not include all information and footnotes necessary for a fair presentation of condensed consolidated financial position, results of operations, comprehensive loss and cash flows in conformity with accounting principles generally accepted in the United States of America (“GAAP”). All intercompany balances and transactions have been eliminated in consolidation. The results of operations for any interim period are not necessarily indicative of the results to be expected for the full year. For further information, refer to the condensed consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018.
The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, RTI Surgical, Inc. (defined as “Legacy RTI” for matters occurring after March 8, 2019, and as the “Company” for matters occurring before March 8, 2019), Paradigm Spine, LLC (“Paradigm”), Pioneer Surgical Technology, Inc. (“Pioneer Surgical”), Tutogen Medical, Inc. (“TMI”), and Zyga Technology, Inc. (“Zyga”). The condensed consolidated financial statements also include the accounts of RTI Donor Services, Inc. (“RTIDS”), which is a controlled entity. Prior to the completion of the acquisition of Paradigm, the financial statements were that of RTI Surgical Inc. and subsidiaries. Subsequently, RTI Surgical Holdings, Inc. and Subsidiaries is the successor reporting company. See Note 6 for further discussion.
3.
|
Recently Issued and Adopted Accounting Standards
|
In May 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Codification (“ASU”) No. 2019-05 Financial Instruments — Credit Losses (Topic 326) which provides relief to certain entities adopting ASU 2016-13 (discussed below). The amendments accomplish those objectives by providing entities with an option to irrevocably elect the fair value option in Subtopic 825-10, applied on an instrument-by-instrument basis for eligible instruments, that are within the scope of Subtopic 326-20, upon adoption of Topic 326. The fair value option election does not apply to held-to-maturity debt securities. ASU 2019-05 has the same transition as ASU 2016-13 and is effective for periods beginning after December 15, 2019, with adoption permitted after this update. The Company is currently evaluating the impact of this new standard on its condensed consolidated financial statements.
In April 2019, the FASB issued ASU No. 2019-04 Codification Improvements to Topic 326, Financial Instruments — Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments, which provides updates and clarifications to three previously-issued ASUs: 2016-01 Financial Instruments — Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities; 2016-13 Financial Instruments — Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, described further above and which the Company has not yet adopted; and 2017-12 Derivatives and Hedging (Topic 815): Targeted Improvements to Accounting for Hedging Activities, which the Company early adopted effective January 1, 2018. The updates related to ASU 2016-13 have the same transition as ASU 2016-13 and are effective for periods beginning after December 15, 2019, with adoption permitted after the issuance of ASU 2019-04. The updates related to ASU 2017-12 are effective for the Company on January 1, 2020. The updates related to ASU 2016-01 are effective for fiscal years beginning after December 15, 2019. The Company is currently evaluating the impact of this new standard on its condensed consolidated financial statements.
6
In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments — Credit Losses. ASU 2016-13 introduces a new model for estimating credit losses for certain types of financial instruments, including loans receivable, held-to-maturity debt securities, and net investments in direct financing leases, amongst other financial instruments. ASU 2016-13 also modifies the impairment model for available-for-sale debt securities and expands the disclosure requirements regarding an entity’s assumptions, models, and methods for estimating the allowance for losses. ASU 2016-13 is effective for periods beginning after December 15, 2019, with adoption permitted for fiscal years beginning after December 15, 2018. Retrospective adjustments shall be applied through a cumulative-effect adjustment to retained earnings. The Company is currently evaluating the impact of this new standard on its condensed consolidated financial statements.
In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), which supersedes existing guidance on accounting for leases in “Leases (Topic 840).” ASU 2016-02 establishes a right-of-use (“ROU”) model that requires operating leases be recorded on the balance sheet through recognition of a liability for the discounted present value of future lease payments and a corresponding ROU asset. The ROU asset recorded at commencement of the lease represents the right to use the underlying asset over the lease term in exchange for the lease payments. Leases with an initial term of 12 months or less and do not have an option to purchase the underlying asset that is deemed reasonably certain to exercise are not recorded on the balance sheet; rather, rent expense for these leases is recognized on a straight-line basis over the lease term. Leases are classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the income statement.
Effective January 1, 2019, the Company adopted the new lease accounting standard using the optional transition method which allowed us to continue to apply the guidance under the lease standard in effect at the time in the comparative periods presented. In addition, the Company elected the package of practical expedients, which allowed us to not reassess whether any existing contracts contain a lease, to not reassess historical lease classification as operating or finance leases, and to not reassess initial direct costs. The Company has not elected the practical expedient to use hindsight to determine the lease term for its leases at transition. The Company has also elected the practical expedient allowing us to not separate the lease and non-lease components for all classes of underlying assets. Adoption of this standard resulted in the recording of operating lease ROU assets and corresponding operating lease liabilities of $3,164 and $3,155, respectively, as of January 1, 2019 with no impact on accumulated deficit. Financial position for reporting periods beginning on or after January 1, 2019, are presented under the new guidance, while prior period amounts are not adjusted and continue to be reported in accordance with previous guidance. Note disclosures required in Topic 842 are reported in Note 4, Leases.
The Company’s leases are classified as operating leases and includes office space, automobiles, and copiers. The Company does not have any finance leases and the Company’s operating leases do not have any residual value guarantees, restrictions or covenants. The Company does not have any leases that have not yet commenced as of September 30, 2019. The majority of our leases have remaining lease terms of 1 to 14 years, some of which include options to extend or terminate the leases. The option to extend is only included in the lease term if the Company is reasonably certain of exercising that option. Operating lease ROU assets are presented within other assets-net on the condensed consolidated balance sheet. The current portion of operating lease liabilities are presented within accrued expenses, and the non-current portion of operating lease liabilities are presented within other long-term liabilities on the condensed consolidated balance sheet.
A subset of the Company’s automobile and copier leases contain variable payments. The variable lease payments for such automobile leases are based on actual mileage incurred at the standard contractual rate. The variable lease payments for such copier leases are based on actual copies incurred at the standard contractual rate. The variable lease costs for all leases are immaterial.
The components of operating lease expense were as follows:
|
For the Three
Months Ended
|
|
|
For the Nine
Months Ended
|
|
|
September 30, 2019
|
|
|
September 30, 2019
|
|
Operating lease cost
|
$
|
437
|
|
|
$
|
1,221
|
|
Short-term operating lease cost
|
|
—
|
|
|
|
36
|
|
Total operating lease cost
|
$
|
437
|
|
|
$
|
1,257
|
|
Supplemental cash flow information related to operating leases was as follows:
7
|
For the Three
Months Ended
|
|
|
For the Nine
Months Ended
|
|
|
September 30, 2019
|
|
|
September 30, 2019
|
|
Cash paid for amounts included in the measurement
of lease liabilities
|
$
|
432
|
|
|
$
|
1,123
|
|
ROU assets obtained in exchange for lease obligations
|
|
—
|
|
|
|
34
|
|
Supplemental balance sheet information related to operating leases was as follows:
|
|
|
|
Balance at
|
|
|
|
Balance Sheet Classification
|
|
September 30, 2019
|
|
Assets:
|
|
|
|
|
|
|
Right-of-use assets
|
|
Other assets - net
|
|
$
|
3,110
|
|
Liabilities:
|
|
|
|
|
|
|
Current
|
|
Accrued expenses
|
|
$
|
1,376
|
|
Noncurrent
|
|
Other long-term liabilities
|
|
|
1,815
|
|
Total operating lease liabilities
|
|
|
|
$
|
3,191
|
|
|
|
|
|
|
|
|
As of September 30, 2019, the weighted-average remaining lease term was 4.7 years. The Company’s lease agreements do not provide a readily determinable implicit rate nor is it available to the Company from its lessors. Instead, the Company estimates its incremental borrowing rate based on information available at lease commencement in order to discount lease payments to present value. The weighted-average discount rate of the Company’s operating leases was 4.7%, as of September 30, 2019.
As of September 30, 2019, maturities of operating lease liabilities were as follows:
|
|
Balance at
|
|
Maturity of Operating Lease Liabilities
|
|
September 30, 2019
|
|
2019 (remaining)
|
|
$
|
434
|
|
2020
|
|
|
1,351
|
|
2021
|
|
|
559
|
|
2022
|
|
|
221
|
|
2023
|
|
|
160
|
|
2024 and beyond
|
|
|
875
|
|
Total future minimum lease payments
|
|
|
3,600
|
|
Less imputed interest
|
|
|
(409
|
)
|
Total
|
|
$
|
3,191
|
|
|
|
|
|
|
As previously disclosed in our 2018 Annual Report on Form 10-K, which followed the lease accounting prior to adoption of ASC 842, future commitments relating to operating leases for the five years and period thereafter as of December 31, 2018 were as follows:
|
|
Balance at
|
|
Maturity of Operating Lease Liabilities
|
|
December 31,
2018
|
|
2019
|
|
$
|
1,374
|
|
2020
|
|
|
806
|
|
2021
|
|
|
276
|
|
2022
|
|
|
162
|
|
2023
|
|
|
166
|
|
2024 and beyond
|
|
|
882
|
|
Total future minimum lease payments
|
|
$
|
3,666
|
|
|
|
|
|
|
8
5.Revenue from Contracts with Customers
The Company operates in one reportable segment composed of four lines of business. The reporting of the Company’s lines of business are composed primarily of four franchises: spine; sports; original equipment manufacturer (“OEM”) and international. The following table presents revenues from these four categories for the three and nine months ended September 30, 2019 and 2018:
|
For the Three Months Ended
|
|
|
For the Nine Months Ended
|
|
|
September 30,
|
|
|
September 30,
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Spine
|
$
|
23,661
|
|
|
$
|
20,741
|
|
|
$
|
70,337
|
|
|
$
|
58,938
|
|
Sports
|
|
12,704
|
|
|
|
12,271
|
|
|
|
40,507
|
|
|
|
39,896
|
|
OEM
|
|
32,341
|
|
|
|
30,092
|
|
|
|
93,815
|
|
|
|
91,382
|
|
International
|
|
7,423
|
|
|
|
5,960
|
|
|
|
23,518
|
|
|
|
19,423
|
|
Total revenues from contracts with customers
|
$
|
76,129
|
|
|
$
|
69,064
|
|
|
$
|
228,177
|
|
|
$
|
209,639
|
|
The following table presents revenues recognized at a point in time and over time for the three and nine months ended September 30, 2019 and 2018:
|
For the Three Months Ended
|
|
|
For the Nine Months Ended
|
|
|
September 30,
|
|
|
September 30,
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
Revenue recognized at a point in time
|
$
|
57,586
|
|
|
$
|
56,401
|
|
|
$
|
176,509
|
|
|
$
|
178,098
|
|
Revenue recognized over time
|
|
18,543
|
|
|
|
12,663
|
|
|
|
51,668
|
|
|
|
31,541
|
|
Total revenues from contracts with customers
|
$
|
76,129
|
|
|
$
|
69,064
|
|
|
$
|
228,177
|
|
|
$
|
209,639
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company’s performance obligations consist mainly of transferring control of implants identified in the contracts. Some of the Company’s contracts offer assurance-type warranties in connection with the sale of a product to a customer. Assurance-type warranties provide a customer with assurance that the related product will function as the parties intended because it complies with agreed-upon specifications. Such warranties do not represent a separate performance obligation and are not material to the condensed consolidated financial statements.
The opening and closing balances of the Company’s accounts receivable, contract asset and current and long-term contract liability for the nine months ended September 30, 2019 and 2018 are as follows:
|
|
|
|
|
|
|
|
|
Contract
|
|
|
|
|
|
|
Contract
|
|
|
Liability
|
|
|
Accounts
|
|
|
Liability
|
|
|
(Long-
|
|
|
Receivable
|
|
|
(Current)
|
|
|
Term)
|
|
Opening Balance, January 1, 2019
|
$
|
48,351
|
|
|
$
|
5,425
|
|
|
$
|
744
|
|
Closing Balance, September 30, 2019
|
|
56,556
|
|
|
|
3,311
|
|
|
|
1,134
|
|
Increase/(decrease)
|
|
8,205
|
|
|
|
(2,114
|
)
|
|
|
390
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contract
|
|
|
|
|
|
|
Contract
|
|
|
Liability
|
|
|
Accounts
|
|
|
Liability
|
|
|
(Long-
|
|
|
Receivable
|
|
|
(Current)
|
|
|
Term)
|
|
Opening Balance, January 1, 2018
|
$
|
38,324
|
|
|
$
|
5,978
|
|
|
$
|
3,741
|
|
Closing Balance, September 30, 2018
|
|
44,141
|
|
|
|
5,892
|
|
|
|
1,968
|
|
Increase/(decrease)
|
|
5,817
|
|
|
|
(86
|
)
|
|
|
(1,773
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
9
Contract liabilities consist primarily of the return allowance described above, and of deferred revenue arising from upfront and annual exclusivity fees. The difference between the opening and closing balances of the Company’s contract liabilities primarily results from the Company’s performance of the Company’s contractual obligations over time. The Company recognizes sales commissions as incurred because the amortization period is less than one year. The Company does not incur other incremental costs relating to obtaining a contract with a customer, and therefore, does not have contract assets, or impairment losses associated therewith. Revenue recognized for the nine months ended September 30, 2019 and 2018, from amounts included in contract liabilities at the beginning of the period were $3,771 and $3,651, respectively.
6.
|
Acquisition of Paradigm Spine, LLC
|
On March 8, 2019, pursuant to the Master Transaction Agreement (the “Master Transaction Agreement”), dated as of November 1, 2018, by and among Legacy RTI, PS Spine Holdco, LLC, a Delaware limited liability company (“PS Spine”), the Company, and Bears Merger Sub, Inc., a Delaware corporation and direct wholly owned subsidiary of the Company (“Merger Sub”), the Company acquired all of the outstanding equity interests of Paradigm, through a transaction in which: (i) PS Spine contributed all of the issued and outstanding equity interests in Paradigm to the Company (the “Contribution”); (ii) Merger Sub merged with and into Legacy RTI (the “Merger”), with Legacy RTI surviving as a wholly owned direct subsidiary of the Company; and (iii) the Company was renamed “RTI Surgical Holdings, Inc.” (collectively, the “Transaction”). Legacy RTI retained its existing name “RTI Surgical, Inc.”
Pursuant to the Master Transaction Agreement: (i) each share of common stock, par value $0.001 per share, of Legacy RTI issued and outstanding immediately prior to the Transaction (other than shares held by Legacy RTI as treasury shares or by the Company or Merger Sub immediately prior to the Transaction, which were automatically cancelled and ceased to exist) was converted automatically into one fully paid and non-assessable share of Company common stock , par value $0.001 per share; (ii) each share of Series A convertible preferred stock, par value $0.001 per share, of Legacy RTI issued and outstanding immediately prior to the Transaction (other than shares held by Legacy RTI as treasury shares or by the Company or Merger Sub immediately prior to the Transaction, which were automatically cancelled and ceased to exist) was converted automatically into one fully paid and non-assessable share of Series A convertible preferred stock, par value $0.001 per share, of the Company; and (iii) each stock option and restricted stock award granted by Legacy RTI was converted into a stock option or restricted stock award, as applicable, of the Company with respect to an equivalent number of shares of the Company common stock on the same terms and conditions as were applicable prior to the closing.
The consideration for the Contribution was $100,000 (the “Cash Consideration Amount”) in cash and 10,729,614 shares of Company common stock (the “Stock Consideration Amount”). The Cash Consideration Amount was adjusted by Paradigm’s working capital of $7,000.
In addition to the Cash Consideration Amount and the Stock Consideration Amount, the Company may be required to make further cash payments or issue additional shares of Company common stock to PS Spine in an amount up to $50,000 of shares of Company common stock to be valued based upon the Legacy RTI Price and an additional $100,000 of cash and/or Company common stock to be valued at the time of issuance, in each case, if certain revenue targets are achieved between closing, March 8, 2019, and December 31, 2022. The Company estimates a contingent liability related to the revenue based earnout of $94,976 utilizing a Monte-Carlo simulation model. A Monte-Carlo simulation is an analytical method used to estimate fair value by performing a large number of simulations or trial runs and thereby determining a value based on the possible outcomes. Accounted for as a liability to be revalued at each reporting period, the preliminary fair value of the contingent liability was measured using Level 3 inputs, which includes weighted average cost of capital and projected revenues and costs. Acquisition and integration related costs were approximately $15,537, of which approximately $4,143 was incurred during 2018, $11,394 (which includes business development expenses of $462 and severance expense of $896) was incurred for the nine months ended September 30, 2019 and is reflected separately in the accompanying condensed consolidated statements of comprehensive (loss) gain. As of September 30, 2019, there was a $34,653 reduction in the contingent liability estimate of the Paradigm acquisition revenue earnout, as the probability weighted model has been updated based on the current updated forecast for the performance of the Paradigm product portfolio.
The Company has accounted for the acquisition of Paradigm under Accounting Standards Codification (“ASC”) 805, Business Combinations. Paradigm’s results of operations are included in the condensed consolidated financial statements beginning after March 8, 2019, the acquisition date.
The purchase price was financed as follows:
|
(In thousands)
|
|
Cash proceeds from second lien credit agreement
|
$
|
100,000
|
|
Fair market value of securities issued
|
|
60,730
|
|
Fair market value of contingent earnout
|
|
60,323
|
|
Total purchase price
|
$
|
221,053
|
|
|
|
|
|
10
The preliminary valuation of the acquired assets and liabilities is not yet complete, and as such, the Company has not yet finalized its allocation of the purchase price for the acquisition. The table below represents the preliminary allocation of the total consideration to Paradigm’s tangible assets and liabilities based on management’s preliminary estimate of their respective fair values as of March 8, 2019.
During the three months ended September 30, 2019, the Company made the following changes to the fair values of acquired assets and liabilities as follows:
|
Balance at
|
|
|
|
|
|
|
September 30, 2019
|
|
|
June 30, 2019
|
|
|
Change
|
|
|
(In thousands)
|
|
Cash
|
$
|
308
|
|
|
$
|
79
|
|
|
$
|
229
|
|
Accounts receivable
|
|
5,220
|
|
|
|
5,220
|
|
|
|
-
|
|
Inventories
|
|
43,084
|
|
|
|
43,084
|
|
|
|
-
|
|
Other current assets
|
|
1,693
|
|
|
|
1,693
|
|
|
|
-
|
|
Property, plant and equipment
|
|
379
|
|
|
|
379
|
|
|
|
-
|
|
Current liabilities
|
|
(6,380
|
)
|
|
|
(6,380
|
)
|
|
|
-
|
|
Net tangible assets acquired
|
|
44,304
|
|
|
|
44,075
|
|
|
|
229
|
|
Goodwill
|
|
176,749
|
|
|
|
211,631
|
|
|
|
(34,882
|
)
|
Total net assets acquired
|
$
|
221,053
|
|
|
$
|
255,706
|
|
|
$
|
(34,653
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
As of March 8, 2019, the inventory fair value was composed of current inventory of $19,703 and non-current inventory of $23,381.
Total net assets acquired as of March 8, 2019, are all part of the Company’s only operating segment. Fair values are based on management’s estimates and assumptions including variations of the income approach, the cost approach and the market approach.
The Company believes that the acquisition of Paradigm, a spine focused business, offers the potential for substantial strategic and financial benefits. The transaction further advances the Company’s strategic transformation focused on reducing complexity, driving operational excellence and accelerating growth. The Company believes the acquisition will enhance stockholder value through, among other things, enabling the Company to capitalize on the following strategic advantages and opportunities:
|
•
|
Paradigm will strengthen the Company’s spine portfolio with the addition of the coflex® Interlaminar Stabilization® device. Coflex is a differentiated and minimally invasive motion preserving stabilization implant that is FDA PMA-approved for the treatment of moderate to severe lumbar spinal stenosis (“LSS”) in conjunction with decompression.
|
|
•
|
Coflex allows the Company to provide surgeons who treat patients with moderate to severe LSS with a PMA-approved device supported by more than 12 years of clinical data.
|
These potential benefits resulted in the Company paying a premium for Paradigm resulting in the preliminary recognition of $176,749 of goodwill assigned to the Company’s only operating segment and reporting unit.
The amount of Paradigm’s revenues and net loss since the March 8, 2019, acquisition date, included in the Company’s condensed consolidated statement of comprehensive (loss) gain for the nine months ended September 30, 2019, excluding acquisition and integration related costs of approximately $11,394, are $20,304 and $99, respectively.
The following unaudited pro forma information shows the results of the Paradigm’s operations as though the acquisition had occurred as of the beginning of the prior comparable period, January 1, 2018, (in thousands):
|
|
For the Nine Months Ended
|
|
|
|
September 30,
|
|
|
|
2018
|
|
Revenues
|
|
$
|
30,532
|
|
Net loss applicable to common shares
|
|
|
(30,604
|
)
|
Net loss applicable to common shares excluding acquisition and integration costs
|
|
|
(30,604
|
)
|
|
|
|
|
|
11
The pro forma results have been prepared for comparative purposes only and are not necessarily indicative of the actual results of operations had the acquisition taken place as of the beginning of the periods presented, or the results that may occur in the future.
7.
|
Acquisition of Zyga Technology, Inc.
|
On January 4, 2018, the Company acquired Zyga Technology, Inc. (“Zyga”), a spine-focused medical device company that develops and produces innovative minimally invasive devices to treat underserved conditions of the lumbar spine. Zyga’s primary product is the SImmetry® Sacroiliac Joint Fusion System. Under the terms of the merger agreement dated January 4, 2018, the Company acquired Zyga for $21,000 in consideration paid at closing (consisting of borrowings of $18,000 on the Company’s revolving credit facility and $3,000 cash on hand), $1,000 contingent upon the successful achievement of a clinical milestone, and a revenue based earnout consideration of up to $35,000. Based on a probability weighted model, the Company estimates a contingent liability related to the clinical milestone and revenue based earnout of $4,986. Acquisition related costs were approximately $1,430, of which approximately $630 was incurred in 2017 and $800 was incurred for the three months ended March 31, 2018 and is reflected separately in the accompanying condensed consolidated statements of comprehensive (loss) gain. As of September 30, 2019, there was a $1,590 reduction in the contingent liability estimate of the Zyga acquisition revenue earnout, as the probability weighted model has been updated based on the current updated forecast for the performance of the Zyga product portfolio.
The Company has accounted for the acquisition of Zyga under ASC 805, Business Combinations. Zyga’s results of operations are included in the condensed consolidated financial statements beginning after January 4, 2018, the acquisition date.
The purchase price was financed as follows:
|
(In thousands)
|
|
Cash proceeds from revolving credit facility
|
$
|
18,000
|
|
Cash from RTI Surgical
|
|
3,000
|
|
Total purchase price
|
$
|
21,000
|
|
In the fourth quarter of 2018, the Company completed its valuation of the purchase price allocation. The table below represents the final allocation of the total consideration to Zyga’s tangible and intangible assets and liabilities fair values as of January 4, 2018.
|
(In thousands)
|
|
Inventories
|
$
|
1,099
|
|
Accounts receivable
|
|
573
|
|
Other current assets
|
|
53
|
|
Property, plant and equipment
|
|
151
|
|
Other assets
|
|
26
|
|
Deferred tax assets
|
|
4,715
|
|
Current liabilities
|
|
(947
|
)
|
Acquisition contingencies
|
|
(4,986
|
)
|
Net tangible assets acquired
|
|
684
|
|
Other intangible assets
|
|
6,760
|
|
Goodwill
|
|
13,556
|
|
Total net assets acquired
|
$
|
21,000
|
|
Total net assets acquired as of January 4, 2018, are all part of the Company’s only operating segment and reporting unit. Fair values are based on management’s estimates and assumptions including variations of the income approach, the cost approach and the market approach. Other intangible assets include patents of $6,500 with a useful life of 13 years, trademarks of $80 with a useful life of 1 year and selling and marketing relationships of $180 with a useful life of 7 years.
The Company believes that the acquisition of Zyga has offered and continues to offer the potential for substantial strategic and financial benefits. The transaction further advances our strategic transformation focused on reducing complexity, driving operational excellence and accelerating growth. The Company believes the acquisition will enhance stockholder value through, among other things, enabling the Company to capitalize on the following strategic advantages and opportunities:
|
•
|
Zyga’s innovative minimally invasive treatment should accentuate our spine portfolio and opens significant opportunities to accelerate our Spine-focused expansion strategy.
|
|
•
|
Zyga should leverage the core competencies of our Spine franchise by pursuing niche differentiated products, to gain scale and customer retention and support portfolio pull-through.
|
12
These potential benefits resulted in the Company paying a premium for Zyga resulting in the recognition of $13,556 of goodwill assigned to the Company’s only operating segment and reporting unit. For tax purposes, none of the goodwill is deductible.
The following unaudited pro forma information shows the results of the Zyga’s operations as though the acquisition had occurred as of the beginning of the prior comparable period, January 1, 2018, (in thousands):
|
For the Nine Months Ended
|
|
|
September 30,
|
|
|
2018
|
|
Revenues
|
$
|
3,595
|
|
Net loss applicable to common shares
|
|
(2,295
|
)
|
The pro forma results have been prepared for comparative purposes only and are not necessarily indicative of the actual results of operations had the acquisition taken place as of the beginning of the periods presented, or the results that may occur in the future. These amounts exclude costs incurred which are directly attributable to the acquisition, and which do not have a continuing impact on the combined companies’ operating results.
8.
|
Stock-Based Compensation
|
The Company’s policy is to grant stock options at an exercise price equal to 100% of the market value of a share of common stock at closing on the date of the grant. The Company’s stock options generally have five to ten-year contractual terms and vest over a one to five-year period from the date of grant. The Company’s policy is to grant restricted stock awards at a fair value equal to 100% of the market value of a share of common stock at closing on the date of the grant. The Company’s restricted stock awards generally vest over one to three-year periods.
2018 Incentive Compensation Plan – On April 30, 2018, the Company’s stockholders approved and adopted the 2018 Incentive Compensation Plan (the “2018 Plan”). The 2018 Plan provides for the grant of incentive and nonqualified stock options and restricted stock to key employees, including officers and directors of the Company and consultants and advisors. The 2018 Plan allows for up to 5,726,035 shares of common stock to be issued with respect to awards granted.
Stock Options
As of September 30, 2019, there was $1,440 of total unrecognized stock-based compensation related to nonvested stock options. The expense related to these stock options is expected to be recognized over a weighted-average period of 2.99 years.
The following table summarizes information about stock options outstanding, exercisable and available for grant as of September 30, 2019:
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
Average
|
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
Remaining
|
|
|
Aggregate
|
|
|
Number of
|
|
|
Exercise
|
|
|
Contractual
|
|
|
Intrinsic
|
|
|
Shares
|
|
|
Price
|
|
|
Life (Years)
|
|
|
Value
|
|
Outstanding at January 1, 2019
|
|
4,295,744
|
|
|
$
|
3.76
|
|
|
|
|
|
|
|
|
|
Granted
|
|
395,900
|
|
|
|
4.68
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
(118,500
|
)
|
|
|
3.34
|
|
|
|
|
|
|
|
|
|
Forfeited or expired
|
|
(197,620
|
)
|
|
|
4.32
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2019
|
|
4,375,524
|
|
|
$
|
3.83
|
|
|
|
5.37
|
|
|
$
|
15
|
|
Vested or expected to vest at September 30, 2019
|
|
4,154,261
|
|
|
$
|
3.79
|
|
|
|
5.19
|
|
|
$
|
15
|
|
Exercisable at September 30, 2019
|
|
3,163,099
|
|
|
$
|
3.56
|
|
|
|
4.20
|
|
|
$
|
15
|
|
Available for grant at September 30, 2019
|
|
4,186,650
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The aggregate intrinsic value in the table above represents the total pre-tax intrinsic value of stock options for which the fair market value of the underlying common stock exceeded the respective stock option exercise price. Estimated forfeitures are based on the Company’s historical forfeiture activity. Compensation expense recognized for all option grants is net of estimated forfeitures and is recognized over the awards’ respective requisite service periods.
13
Other information concerning stock options are as follows:
|
For the Nine Months Ended
|
|
|
September 30,
|
|
|
2019
|
|
|
2018
|
|
Weighted average fair value of stock options granted
|
$
|
1.97
|
|
|
$
|
2.05
|
|
Aggregate intrinsic value of stock options exercised
|
|
161
|
|
|
|
344
|
|
The aggregate intrinsic value of stock options exercised in a period represents the pre-tax cumulative difference, for the stock options exercised during the period, between the fair market value of the underlying common stock and the stock option exercise prices.
Restricted Stock Awards
As of September 30, 2019, there was $2,991 of total unrecognized stock-based compensation related to unvested restricted stock awards. That expense is expected to be recognized on a straight-line basis over a weighted-average period of 1.63 years. The following table summarizes information about unvested restricted stock awards as of September 30, 2019:
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
Average
|
|
|
Number of
|
|
|
Grant Date
|
|
|
Shares
|
|
|
Fair Value
|
|
Unvested at January 1, 2019
|
|
1,075,215
|
|
|
$
|
4.29
|
|
Granted
|
|
667,205
|
|
|
|
4.80
|
|
Vested
|
|
(458,646
|
)
|
|
|
4.16
|
|
Forfeited
|
|
(81,169
|
)
|
|
|
4.86
|
|
Unvested at September 30, 2019
|
|
1,202,605
|
|
|
$
|
4.61
|
|
|
|
|
|
|
|
|
|
Restricted Stock Units
As of September 30, 2019, there was $903 of total unrecognized stock-based compensation related to unvested restricted stock units. That expense is expected to be recognized on a straight-line basis over a weighted-average period of 2.25 years. The following table summarizes information about unvested restricted stock units as of September 30, 2019:
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
Average
|
|
|
Number of
|
|
|
Grant Date
|
|
|
Shares
|
|
|
Fair Value
|
|
Unvested at January 1, 2019
|
|
—
|
|
|
$
|
—
|
|
Granted
|
|
226,352
|
|
|
|
7.41
|
|
Vested
|
|
—
|
|
|
|
—
|
|
Forfeited
|
|
(41,770
|
)
|
|
|
7.41
|
|
Unvested at September 30, 2019
|
|
184,582
|
|
|
$
|
7.41
|
|
For the three and nine months ended September 30, 2019 and 2018, the Company recognized stock-based compensation as follows:
|
For the Three Months Ended
|
|
|
For the Nine Months Ended
|
|
|
September 30,
|
|
|
September 30,
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
Stock-based compensation:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs of processing and distribution
|
$
|
36
|
|
|
$
|
33
|
|
|
$
|
108
|
|
|
$
|
99
|
|
Marketing, general and administrative
|
|
918
|
|
|
|
1,032
|
|
|
|
3,246
|
|
|
|
3,506
|
|
Research and development
|
|
15
|
|
|
|
15
|
|
|
|
45
|
|
|
|
45
|
|
Total
|
$
|
969
|
|
|
$
|
1,080
|
|
|
$
|
3,399
|
|
|
$
|
3,650
|
|
14
9.
|
Net Income Per Common Share
|
A reconciliation of the number of shares of common stock used in the calculation of basic and diluted net income per common share is presented below:
|
For the Three Months Ended
|
|
|
For the Nine Months Ended
|
|
|
September 30,
|
|
|
September 30,
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
Basic shares
|
|
75,194,036
|
|
|
|
63,495,952
|
|
|
|
72,007,860
|
|
|
|
63,517,958
|
|
Effect of dilutive securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options
|
|
—
|
|
|
|
675,028
|
|
|
|
—
|
|
|
|
—
|
|
Preferred stock Series A
|
|
—
|
|
|
|
15,113,335
|
|
|
|
—
|
|
|
|
—
|
|
Diluted shares
|
|
75,194,036
|
|
|
|
79,284,315
|
|
|
|
72,007,860
|
|
|
|
63,517,958
|
|
For the three months ended September 30, 2019 and 2018, approximately 2,315,856 and 1,474,375, respectively, and for the nine months ended September 30, 2019 and 2018, approximately 1,653,991 and 1,456,829, respectively, of issued stock options were not included in the computation of diluted net loss per common share because they were anti-dilutive because their exercise price exceeded the market price. For the three months and nine ended September 30, 2019, options to purchase 327,085 and 667,015, respectively, shares of common stock were not included in the computation of diluted loss per share because dilutive shares are not factored into this calculation when net loss is reported. For the nine months ended September 30, 2018, options to purchase 608,390 shares of common stock were not included in the computation of diluted loss per share because dilutive shares are not factored into this calculation when a net loss is reported.
For the three and nine months ended September 30, 2019, 50,000 shares of convertible preferred stock or 15,152,761of converted common stock and accrued but unpaid dividends were anti-dilutive on an as if-converted basis and were not included in the computation of diluted net loss per common share. For the nine months ended September 30, 2018, 50,000 shares of convertible preferred stock or 15,113,335 of converted common stock and accrued but unpaid dividends were anti-dilutive on an as if-converted basis and were not included in the computation of diluted net loss per common share.
Inventories by stage of completion are as follows:
|
September 30,
|
|
|
December 31,
|
|
|
2019
|
|
|
2018
|
|
Unprocessed tissue, raw materials and supplies
|
$
|
27,170
|
|
|
$
|
24,211
|
|
Tissue and work in process
|
|
34,186
|
|
|
|
31,796
|
|
Implantable tissue and finished goods
|
|
87,902
|
|
|
|
51,464
|
|
Total
|
|
149,258
|
|
|
|
107,471
|
|
Less current portion
|
|
130,913
|
|
|
|
107,471
|
|
Long-term portion
|
$
|
18,345
|
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
For the three months ended September 30, 2019 and 2018, the Company had inventory write-downs of $2,208 and $2041, respectively, and for the nine months ended September 30, 2019 and 2018, the Company had inventory write-downs of $5,482 and $12,906, respectively, relating primarily to product obsolescence. As of September 30, 2019, the long-term portion of inventory relates to finished goods.
Included in the three months ended March 31, 2018, are $1,023 of product obsolescence which was due to the rationalization of our international distribution infrastructure. Included in the three months ended June 30, 2018, was $6,559 of inventory write-off which was due to the suspension of the map3® implant.
11.
|
Prepaid and Other Current Assets
|
15
Prepaid and Other Current Assets are as follows:
|
September 30,
|
|
|
December 31,
|
|
|
2019
|
|
|
2018
|
|
Income tax receivable
|
$
|
3,222
|
|
|
$
|
3,920
|
|
Prepaid expenses
|
|
5,016
|
|
|
|
4,127
|
|
Other
|
|
393
|
|
|
|
744
|
|
|
$
|
8,631
|
|
|
$
|
8,791
|
|
12.
|
Property, Plant and Equipment
|
Property, plant and equipment are as follows:
|
September 30,
|
|
|
December 31,
|
|
|
2019
|
|
|
2018
|
|
Land
|
$
|
1,982
|
|
|
$
|
2,020
|
|
Buildings and improvements
|
|
57,906
|
|
|
|
58,093
|
|
Processing equipment
|
|
46,046
|
|
|
|
42,599
|
|
Surgical instruments
|
|
27,164
|
|
|
|
24,070
|
|
Office equipment, furniture and fixtures
|
|
1,994
|
|
|
|
1,877
|
|
Computer equipment and software
|
|
19,146
|
|
|
|
18,873
|
|
Construction in process
|
|
12,757
|
|
|
|
8,934
|
|
|
|
166,995
|
|
|
|
156,466
|
|
Less accumulated depreciation
|
|
(85,789
|
)
|
|
|
(78,512
|
)
|
|
$
|
81,206
|
|
|
$
|
77,954
|
|
For the three months ended September 30, 2019 and 2018, the Company had depreciation expense in connection with property, plant and equipment of $2,898 and $2,577, respectively, and for the nine months ended September 30, 2019 and 2018, the Company had depreciation expense in connection with property, plant and equipment of $8,437 and $7,824, respectively. For the three months ended June 30, 2018, the Company had $1,797 of asset impairment and abandonment charges relating to the suspension of the map3® implant.
Goodwill acquired during the nine months ended September 30, 2019, includes the excess of the Paradigm purchase price over the sum of the amounts assigned to assets acquired less liabilities assumed.
|
September 30,
|
|
|
December 31,
|
|
|
2019
|
|
|
2018
|
|
Balance at January 1
|
$
|
59,798
|
|
|
$
|
46,242
|
|
Goodwill acquired related to Zyga acquisition
|
|
—
|
|
|
|
13,556
|
|
Goodwill acquired related to Paradigm acquisition
|
|
176,749
|
|
|
|
—
|
|
Balance at end of period
|
$
|
236,547
|
|
|
$
|
59,798
|
|
14.
|
Other Intangible Assets
|
Other intangible assets are as follows:
|
September 30, 2019
|
|
|
December 31, 2018
|
|
|
Gross
|
|
|
|
|
|
|
Net
|
|
|
Gross
|
|
|
|
|
|
|
Net
|
|
|
Carrying
|
|
|
Accumulated
|
|
|
Carrying
|
|
|
Carrying
|
|
|
Accumulated
|
|
|
Carrying
|
|
|
Amount
|
|
|
Amortization
|
|
|
Amount
|
|
|
Amount
|
|
|
Amortization
|
|
|
Amount
|
|
Patents
|
$
|
16,376
|
|
|
$
|
5,014
|
|
|
$
|
11,362
|
|
|
$
|
16,092
|
|
|
$
|
4,194
|
|
|
$
|
11,898
|
|
Acquired licensing rights
|
|
7,452
|
|
|
|
2,076
|
|
|
|
5,376
|
|
|
|
11,852
|
|
|
|
6,468
|
|
|
|
5,384
|
|
Marketing and procurement and other intangible assets
|
|
20,181
|
|
|
|
12,574
|
|
|
|
7,607
|
|
|
|
20,356
|
|
|
|
11,279
|
|
|
|
9,077
|
|
Total
|
$
|
44,009
|
|
|
$
|
19,664
|
|
|
$
|
24,345
|
|
|
$
|
48,300
|
|
|
$
|
21,941
|
|
|
$
|
26,359
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended September 30, 2019 and 2018, the Company had amortization expense of other intangible assets of $1,024 and $1,149, respectively, and for the nine months ended September 30, 2019 and 2018, the Company had amortization
16
expense of other intangible assets of $2,976 and $2,970, respectively. For the three months ended June 30, 2018, the Company had $2,718 of asset impairment and abandonment charges related to the suspension of the map3® implant.
At September 30, 2019, management’s estimates of future amortization expense for the next five years are as follows:
|
Amortization
|
|
|
Expense
|
|
2019 (remaining)
|
$
|
1,050
|
|
2020
|
|
4,100
|
|
2021
|
|
4,100
|
|
2022
|
|
4,100
|
|
2023
|
|
1,800
|
|
2024
|
|
1,800
|
|
Accrued expenses are as follows:
|
September 30,
|
|
|
December 31,
|
|
|
2019
|
|
|
2018
|
|
Accrued compensation
|
$
|
4,641
|
|
|
$
|
8,678
|
|
Accrued severance and restructuring costs
|
|
518
|
|
|
|
931
|
|
Accrued distributor commissions
|
|
4,019
|
|
|
|
3,907
|
|
Accrued donor recovery fees
|
|
10,217
|
|
|
|
4,088
|
|
Accrued leases
|
|
1,376
|
|
|
|
-
|
|
Accrued acquisition and integration expenses
|
|
2,725
|
|
|
|
-
|
|
Other
|
|
7,571
|
|
|
|
7,079
|
|
|
$
|
31,067
|
|
|
$
|
24,683
|
|
|
|
|
|
|
|
|
|
16.
|
Short and Long-Term Obligations
|
Short and long-term obligations are as follows:
|
September 30,
|
|
|
December 31,
|
|
|
2019
|
|
|
2018
|
|
Ares Term loan
|
$
|
102,948
|
|
|
$
|
—
|
|
JPM facility
|
|
67,500
|
|
|
|
50,000
|
|
Less unamortized debt issuance costs
|
|
(1,311
|
)
|
|
|
(927
|
)
|
Total
|
|
169,137
|
|
|
|
49,073
|
|
Less current portion
|
|
—
|
|
|
|
—
|
|
Long-term portion
|
$
|
169,137
|
|
|
$
|
49,073
|
|
|
|
|
|
|
|
|
|
On June 5, 2018, the Company, along with its wholly-owned subsidiary, Pioneer Surgical, entered into a Credit Agreement (the “2018 Credit Agreement”), as borrowers, with JP Morgan Chase Bank, N.A., as lender (together with the various financial institutions as in the future may become parties thereto, the “JPM Lenders”) and as administrative agent for the JPM Lenders. The 2018 Credit Agreement provides for a revolving credit facility in the aggregate principal amount of up to $100,000 (the “JPM Facility”) (subsequently reduced to $75,000, as described below). The Company and Pioneer Surgical will be able to, at their option, and subject to customary conditions and JPM Lender approval, request an increase to the JPM Facility in an amount not to exceed $50,000.
The JPM Facility is guaranteed by the Company’s domestic subsidiaries and is secured by: (i) substantially all of the assets of the Company and Pioneer Surgical; (ii) substantially all of the assets of each of the Company’s domestic subsidiaries; and (iii) 65% of the stock of the Company’s foreign subsidiaries.
The initial borrowings made under the 2018 Credit Agreement will bear interest at a rate per annum equal to the monthly REVLIBOR30 Rate (“CBFR Loans”) plus an adjustable margin of up to 2.00% (the “CBFR Rate”). The Company may elect to convert the interest rate for the initial borrowings to a rate per annum equal to the adjusted LIBO Rate (“Eurodollar Loans”) plus an adjustable margin of up to 2.00% (the “JPM Eurodollar Rate”). For all subsequent borrowings, the Company may elect to apply either the CBFR Rate or JPM Eurodollar Rate. The applicable margin is subject to adjustment after the end of each fiscal quarter, based upon
17
the Company’s average quarterly availability. The maturity date of the JPM Facility is June 5, 2023. The Company may make optional prepayments on the JPM Facility without penalty. The Company paid certain customary closing costs and bank fees upon entering into the 2018 Credit Agreement.
The Company is subject to certain affirmative and negative covenants, including (but not limited to), covenants limiting the Company’s ability to: incur certain additional indebtedness; create certain liens; enter into sale and leaseback transactions; and consolidate or merge with, or convey, transfer or lease all or substantially all of its assets to another person. The Company is required to maintain a minimum fixed charge coverage ratio of at least 1.00:1.00 (the “JPM Required Minimum Fixed Charge Coverage Ratio”) during either of the following periods (each, a “JPM Covenant Testing Period”): (i) a period beginning on a date that a default has occurred and is continuing under the loan documents entered into by the Company in conjunction with the 2018 Credit Agreement through the first date on which no default has occurred and is continuing; or (ii) a period beginning on a date that availability under the JPM Facility is less than the specified covenant testing threshold and continuing until availability under the JPM Facility is greater than or equal to the specified covenant testing threshold for thirty (30) consecutive days. The JPM Required Minimum Fixed Charge Coverage Ratio is measured on the last day of each calendar month during the JPM Covenant Testing Period (each a “JPM Calculation Date”), and is calculated using the minimum fixed charge coverage ratio for the twelve (12) consecutive months ending on each JPM Calculation Date. The amounts owed under the 2018 Credit Agreement may be accelerated upon the occurrence of certain events of default customary for facilities for similarly rated borrowers.
First Amendment to Credit Agreement and Joinder Agreement
On March 8, 2019, the Company entered into a First Amendment to Credit Agreement and Joinder Agreement dated as of March 8, 2019 (the “2019 First Amendment”), among the Company, Legacy RTI, as a borrower, Pioneer Surgical, as a borrower, the other loan parties thereto as guarantors, JP Morgan Chase Bank, N.A., as lender (together with the various financial institutions as in the future may become parties thereto) and as administrative agent for the JPM Lenders. The 2019 First Amendment amended the 2018 Credit Agreement by: (i) reducing the aggregate revolving commitments available to Legacy RTI and Pioneer Surgical from $100,000 to $75,000; (ii) joining the Company and Paradigm, and its domestic subsidiaries as guarantors and loan parties to the 2018 Credit Agreement; (iii) permitting the Ares Term Loan (as defined below); and (iv) making certain other changes to the 2018 Credit Agreement consistent with the foregoing including pro rata reductions to certain thresholds that were based on the aggregate commitments under the 2018 Credit Agreement.
At September 30, 2019, the interest rate for the JPM Facility was 4.10%. As of September 30, 2019, there was $67,500 outstanding on the JPM Facility and total remaining available credit on the JPM Facility was $7,500. The Company’s ability to access the JPM Facility is subject to and can be limited by the Company’s compliance with the Company’s financial and other covenants. The Company was in compliance with the financial covenants related to the JPM Facility as of September 30, 2019.
Second Lien Credit Agreement and Term Loan
On March 8, 2019, Legacy RTI entered into a Second Lien Credit Agreement dated as of March 8, 2019 (the “2019 Credit Agreement”), among Legacy RTI, as a borrower, the other loan parties thereto as guarantors (together with Legacy RTI, the “Ares Loan Parties”), Ares Capital Corporation, as lender (together with the various financial institutions as in the future may become parties thereto, the “Ares Lenders”) and as administrative agent for the Ares Lenders. The 2019 Credit Agreement provides for a term loan in the principal amount of up to $100,000 (the “Ares Term Loan”). The Ares Term Loan was advanced in a single borrowing on March 8, 2019.
The Ares Term Loan is guaranteed by the Company and each of the Company’s domestic subsidiaries and is secured by: (i) substantially all of the assets of Legacy RTI; (ii) substantially all of the assets of the Company; (iii) substantially all of the assets of the Company’s domestic subsidiaries; and (iv) 65% of the stock of the Company’s foreign subsidiaries.
The Ares Term Loan will bear interest at a rate per annum equal to, at the option of Legacy RTI: (i) the monthly Base Rate plus an adjustable margin of up to 7.50% (the “Base Rate”); or (ii) the LIBOR plus an adjustable margin of up to 8.50% (the “Ares Eurodollar Rate”). Subject to customary notices, Legacy RTI may elect to convert the Ares Term Loan from Base Rate to Ares Eurodollar Rate or from Ares Eurodollar Rate to Base Rate. The applicable margin is subject to adjustment after the end of each fiscal quarter, based upon the Ares Loan Parties’ total net leverage ratio. At any time during the period commencing on March 8, 2019 and ending on March 8, 2021, if the Ares Loan Parties’ total net leverage ratio is greater than 4.50:1.00, Legacy RTI shall have the option (the “PIK Option”) to elect to pay 50% of the interest that will accrue in the subsequent quarterly period in kind by capitalizing it and adding such amount to the principal balance of the Ares Term Loan. If Legacy RTI exercises the PIK Option, the adjustable margin applicable to the Ares Term Loan shall be increased by 0.75%.
The maturity date of the Ares Term Loan is December 5, 2023. Legacy RTI may make optional prepayments on the Ares Term Loan, provided that any such optional prepayments made on or prior to March 8, 2022, shall be subject to a make whole premium or a prepayment price, as the case may be. Legacy RTI is required to make mandatory prepayments of the Ares Term Loan based on excess cash flow and the Ares Loan Parties’ total net leverage ratio, upon the incurrence of certain indebtedness not
18
otherwise permitted under the 2019 Credit Agreement, upon consummation of certain dispositions, and upon the receipt of certain proceeds of casualty events. Legacy RTI was required to pay certain customary closing costs and bank fees upon entering into the 2019 Credit Agreement.
Legacy RTI is subject to certain affirmative and negative covenants, including (but not limited to), covenants limiting Legacy RTI’s ability to: incur certain additional indebtedness; create certain liens; enter into sale and leaseback transactions; and consolidate or merge with, or convey, transfer or lease all or substantially all of its assets to another person. During any period beginning on a date that either: (i) a default has occurred and is continuing under the loan documents entered into by Legacy RTI in conjunction with the Credit Agreement (the “Ares Loan Documents”); or (ii) availability under the Ares Term Loan is less than the specified covenant testing threshold, and continuing until either (a) no default has occurred and is continuing under the Ares Loan Documents or (b) availability under the Ares Term Loan is greater than or equal to the specified covenant testing threshold for thirty (30) consecutive days, respectively, (the “Ares Covenant Testing Period”) Legacy RTI is required to maintain a minimum fixed charge coverage ratio of at least 0.91:1.00 (the “Ares Required Minimum Fixed Charge Coverage Ratio”). The Ares Required Minimum Fixed Charge Coverage Ratio is measured on the last day of each calendar month during the Ares Covenant Testing Period (each a “Ares Calculation Date”), and is calculated using the minimum fixed charge coverage ratio for the twelve (12) consecutive months ending on each Ares Calculation Date. The Ares Loan Parties are required to maintain an initial total net leverage ratio of 9.00:1.00, which ratio steps down each fiscal quarter of Legacy RTI resulting in a requirement that the Ares Loan Parties maintain a total net leverage ratio of 3.50:1.00 for the fiscal quarter ending June 30, 2021, and each fiscal quarter ending thereafter.
The amounts owed under the 2019 Credit Agreement may be accelerated upon the occurrence of certain events of default customary for facilities for similarly rated borrowers.
At September 30, 2019, the interest rate for the Ares Term Loan was 10.79%. The Company was in compliance with the financial covenants related to the Ares Term Loan as of September 30, 2019.
For the nine months ended September 30, 2019 and 2018, interest expense associated with the amortization of debt issuance costs was $442 and $476, respectively. Included in the nine months ended September 30, 2019, was $219 of accelerated amortization of debt issuance costs associated with the modification of the 2018 Credit Agreement. For the nine months ended September 30, 2019, the Company incurred total debt issuance cost of $826.
As of September 30, 2019, the Company had approximately $2,950 of cash and cash equivalents and $7,500 of availability under its revolver agreement. For the nine-month period ended September 30, 2019, the Company used approximately $12,709 of cash in its operations.
To maintain adequate available liquidity and execute on the Company’s current business plan, which includes the integration of recent acquisitions, the Company intends to utilize cash flow from operations to fund business expenses. In addition, the Company intends to manage the timing and payment of variable expenditures and utilize available working capital. As of November 7, 2019, the Company believes that its working capital, together with available borrowings under the revolving credit facility will be adequate to fund ongoing operations for the next twelve months.
The Company’s debt agreements contain a leverage to EBITDA covenant, which as of September 30, 2019, required the Company to maintain a 6:1 leverage to trailing twelve-month adjusted EBITDA ratio. The debt agreement successively reduces the covenant ratio to 5:1, 4.75:1, 4.5:1, and 4.25:1, over each of the next four quarters. The Company’s leverage ratio as of September 30, 2019 is approximately 5.0:1. If the Company is unable to execute on its acquisition integration plans or achieve its projected growth and cash flow targets, its available liquidity could be further limited, and its operations may lead to defaults under the borrowing agreements.
17.
|
Other long-term liabilities
|
Other long-term liabilities are as follows:
|
September 30,
|
|
|
December 31,
|
|
|
2019
|
|
|
2018
|
|
Acquisition contingencies
|
$
|
63,719
|
|
|
$
|
4,986
|
|
Other
|
|
2,271
|
|
|
|
633
|
|
|
$
|
65,990
|
|
|
$
|
5,619
|
|
Acquisition contingencies represent the Company’s fair value estimate of the Zyga acquisition clinical and revenue milestones of $3,396 and the Company’s preliminary fair value estimate of the Paradigm acquisition revenue earnout contingency of $60,323. As of September 30, 2019, there was a $1,590 reduction in the contingent liability estimate of the Zyga acquisition revenue earnout, as the probability weighted model has been updated based on the current updated forecast for the performance of the Zyga
19
product portfolio. As of September 30, 2019, there was a $34,653 reduction in the contingent liability estimate of the Paradigm acquisition revenue earnout, as the probability weighted model has been updated based on the current updated forecast for the performance of the Paradigm product portfolio.
The Company expects its deferred tax assets of $20,967, net of the valuation allowance at September 30, 2019 of $3,082, to be realized through the generation of future taxable income and the reversal of existing taxable temporary differences.
The Company evaluates the need for deferred tax asset valuation allowances based on a more likely than not standard. The ability to realize deferred tax assets depends on the ability to generate sufficient taxable income within the carryback or carryforward periods provided for in the tax law for each applicable tax jurisdiction.
The assessment regarding whether a valuation allowance is required or should be adjusted also considers all available positive and negative evidence. It is difficult to conclude a valuation allowance is not required when there is significant objective and verifiable negative evidence, such as cumulative losses in recent years. The Company utilizes a rolling three-years of actual results as the primary measure of cumulative income or losses in recent years.
On a rolling three-years, the Company’s consolidated U.S. operations are in a cumulative income position. However, one U.S. entity is in a three-year cumulative loss position. The Company has established a valuation allowance on this entity’s separate state deferred tax assets.
The Company’s foreign operations are in a three-year cumulative loss position. Future taxable income exclusive of reversing temporary differences and carryforwards is one source of taxable income that may be available under the tax law to realize a tax benefit for deductible temporary differences and carryforwards. Beginning in 2017, the Company began a restructuring plan, which was finalized in 2018. The efforts under this plan have led the Company to achieve operational improvements and a reduction in complexities which has contributed to current year and projected future earnings within its foreign subsidiary. The Company considers the current year and projected future earnings to be objectively verifiable evidence which will allow the Company to fully utilize its foreign deferred tax assets. The Company believes this positive evidence outweighs the negative evidence of its foreign subsidiaries’ cumulative three-year loss position. As a result, no valuation allowances have been established against its foreign subsidiaries’ deferred tax assets.
The Company will continue to regularly assess the realizability of its deferred tax assets. Changes in historical earnings performance and future earnings projections, among other factors, may cause the Company to adjust its valuation allowance, which would impact the Company’s income tax expense in the period the Company determines that these factors have changed.
On June 12, 2013, the Company and WSHP Biologics Holdings, LLC, an affiliate of Water Street Healthcare Partners, a leading healthcare-focused private equity firm (“Water Street”), entered into an investment agreement. Pursuant to the terms of the investment agreement, the Company issued $50,000 of convertible preferred equity to Water Street in a private placement which closed on July 16, 2013, with preferred stock issuance costs of $1,290. Before July 16, 2018, the preferred stock accrued dividends at a rate of 6% per annum. Dividends that were not paid in cash in any quarter accrued on each outstanding share of preferred stock during such three-month period and accumulated.
On August 1, 2018, the Company and Water Street, a related party, entered into an Amended and Restated Certificate of Designation of Series A Convertible Preferred Stock of RTI Surgical, Inc. (the “Amended and Restated Certificate of Designation”). Pursuant to the Amended and Restated Certificate of Designation: (1) dividends on the Series A Preferred Stock will not accrue after July 16, 2018 (in the event of a default by the Company, dividends will begin accruing and will continue to accrue until the default is cured); (2) the Company may not force a redemption of the Series A Preferred Stock prior to July 16, 2020; and (3) the holders of the Series A Preferred Stock may not convert the Series A Preferred Stock into common stock prior to July 16, 2021 (with certain exceptions). The Company evaluated and concluded on a qualitative basis the amendment qualifies as modification accounting to the preferred shares, which did not result in a change in the valuation of the shares.
20
Preferred stock is as follows:
|
Preferred
Stock
Liquidation
|
|
|
Preferred
Stock
Issuance
|
|
|
Net
|
|
|
Value
|
|
|
Costs
|
|
|
Total
|
|
Balance at January 1, 2019
|
$
|
66,519
|
|
|
$
|
(293
|
)
|
|
$
|
66,226
|
|
Amortization of preferred stock issuance costs
|
|
—
|
|
|
|
138
|
|
|
|
138
|
|
Balance at September 30, 2019
|
$
|
66,519
|
|
|
$
|
(155
|
)
|
|
$
|
66,364
|
|
20.
|
Severance and Restructuring Costs
|
The Company recorded severance and restructuring costs related to the reduction of our organizational structure which resulted in $2,280 of expenses for the year ended December 31, 2018. As part of the acquisition of Paradigm, management implemented a plan which resulted in $896 of severance expenses for the nine months ended September 30, 2019 included in acquisition and integration expenses within the condensed consolidated statements of comprehensive (loss) gain. The total severance and restructuring costs are expected to be paid in full by the fourth quarter of 2019. Severance and restructuring payments are made over periods ranging from one month to twelve months and are not expected to have a material impact on cash flows of the Company in any quarterly period. The following table includes a roll-forward of severance and restructuring costs included in accrued expenses, see Note 15.
Accrued severance and restructuring costs at January 1, 2019
|
$
|
931
|
|
Severance and restructuring costs accrued in 2019
|
|
896
|
|
Subtotal severance and restructuring costs
|
|
1,827
|
|
Severance and restructuring related cash payments
|
|
(1,309
|
)
|
Accrued severance and restructuring charges at September 30, 2019
|
$
|
518
|
|
|
|
|
|
21.
|
Executive Transition Costs
|
The Company recorded Chief Executive Officer retirement and transition costs related to the retirement of our former Chief Executive Officer pursuant to the Executive Transition Agreement dated August 29, 2012 (as amended and extended to date), which resulted in $4,404 of expenses for the year ended December 31, 2016. The total Chief Executive Officer retirement and transition costs were paid in full in the first quarter of 2019. The following table includes a roll-forward of executive transition costs included in accrued expenses, see Note 15.
Accrued executive transition costs at January 1, 2019
|
$
|
43
|
|
Cash payments
|
|
(43
|
)
|
Accrued executive transition costs at September 30, 2019
|
$
|
-
|
|
|
|
|
|
22.
|
Commitments and Contingencies
|
Agreement to Acquire Paradigm – On March 8, 2019, pursuant to the Master Transaction Agreement, the Company acquired Paradigm in a cash and stock transaction valued at up to $300,000, consisting of $150,000 on March 8, 2019, plus potential future milestone payments. Established in 2005, Paradigm’s primary product is the coflex® Interlaminar Stabilization® device, a differentiated and minimally invasive motion preserving stabilization implant that is FDA premarket approved for the treatment of moderate to severe lumbar spinal stenosis in conjunction with decompression.
Under the terms of the agreement, the Company paid $100,000 in cash and issued 10,729,614 shares of the Company’s common stock. The shares of Company common stock issued on March 8, 2019, were valued based on the volume weighted average closing trading price for the five trading days prior to the date of execution of the definitive agreement, representing $50,000 of value. In addition, the Company may be required to pay up to an additional $150,000 in a combination of cash and Company common stock based on a revenue earnout consideration. Based on a probability weighted model, the Company estimates a preliminary contingent liability related to the revenue based earnout of $60,323. The Company has not completed its preliminary purchase price allocation.
Acquisition of Zyga – On January 4, 2018, the Company acquired Zyga, a leading spine-focused medical device company that develops and produces innovative minimally invasive devices to treat underserved conditions of the lumbar spine. Zyga’s primary product is the SImmetry® Sacroiliac Joint Fusion System. Under the terms of the merger agreement dated January 4, 2018, the Company acquired Zyga for $21,000 in consideration paid at closing (consisting of borrowings of $18,000 on its revolving credit facility and $3,000 cash on hand), $1,000 contingent upon the successful achievement of a clinical milestone, and a revenue based earnout consideration of up to an
21
additional $35,000. Based on a probability weighted model, the Company estimates a contingent liability related to the clinical and revenue milestones of $3,396, see Note 17.
Distribution Agreement with Medtronic – On October 12, 2013, the Company entered into a replacement distribution agreement with Medtronic, plc. (“Medtronic”), as amended January 1, 2019, pursuant to which Medtronic will distribute certain allograft implants for use in spinal, general orthopedic and trauma surgery. Under the terms of this distribution agreement, Medtronic is a non-exclusive distributor except for certain specified implants for which Medtronic is the exclusive distributor. Medtronic will maintain its exclusivity with respect to these specified implants unless the cumulative fees received by the Company from Medtronic for these specified implants decline by a certain amount during any trailing 12-month period. The initial term of this distribution agreement was to have been through December 31, 2017. The term automatically renews for successive five-year periods, unless either party provides written notice of its intent not to renew at least one year prior to the expiration of the applicable renewal period. The distribution agreement will continue at least through December 31, 2022.
Distribution Agreement with Zimmer Dental Inc. - On September 3, 2010, the Company entered into an exclusive distribution agreement with Zimmer Dental, Inc. (“Zimmer Dental”), a subsidiary of Zimmer, with an effective date of September 30, 2010, as amended from time to time. The Agreement was assigned to Biomet 3i, LLC (“Biomet”), an affiliate of Zimmer Dental, on January 1, 2016. The Agreement has an initial term of ten years. Under the terms of this distribution agreement, the Company agreed to supply sterilized allograft and xenograft implants at an agreed upon transfer price, and Biomet agreed to be the exclusive distributor of the implants for dental and oral applications worldwide (except Ukraine), subject to certain Company obligations under an existing distribution agreement with a third party with respect to certain implants for the dental market. In consideration for Biomet’s exclusive distribution rights, Biomet agreed to the following: 1) payment to the Company of $13,000 within ten days of the effective date (the “Upfront Payment”); 2) annual exclusivity fees (“Annual Exclusivity Fees”) paid annually as long as Biomet maintains exclusivity for the term of the contract to be paid at the beginning of each calendar year; and 3) annual purchase minimums to maintain exclusivity. Upon occurrence of an event that materially and adversely affects Biomet’s ability to distribute the implants, Biomet may be entitled to certain refund rights with respect to the then current Annual Exclusivity Fee, where such refund would be in an amount limited by a formula specified in this agreement that is based substantially on the occurrence’s effect on Biomet’s revenues. The Upfront Payment, the Annual Exclusivity Fees and the fees associated with distributions of processed tissue are considered to be a single performance obligation. Accordingly, the Upfront Payment and the Annual Exclusivity Fees are deferred as received and are being recognized as other revenues over the term of this distribution agreement based on the expected contractual annual purchase minimums relative to the total contractual minimum purchase requirements in this distribution agreement. Additionally, the Company considered the potential impact of this distribution agreement’s contractual refund provisions and does not expect these provisions to impact future expected revenue related to this distribution agreement.
The Company’s aforementioned revenue recognition methods related to the Zimmer distribution agreements do not result in the deferral of revenue less than amounts that would be refundable in the event the agreements were to be terminated in future periods. Additionally, the Company evaluates the appropriateness of the aforementioned revenue recognition methods on an ongoing basis.
The Company is, from time to time, involved in litigation relating to claims arising out of its operations in the ordinary course of business. The Company believes that none of these claims that were outstanding as of September 30, 2019, will have a material adverse impact on its financial position or results of operations.
Coloplast — The Company is presently named as co-defendant along with other companies in a small percentage of the transvaginal surgical mesh (“TSM”) mass tort claims being brought in various state and federal courts. The TSM litigation has as its catalyst various Public Health Notifications issued by the FDA with respect to the placement of certain TSM implants that were the subject of 510k regulatory clearance prior to their distribution. The Company does not process or otherwise manufacture for distribution in the U.S. any implants that were the subject of these FDA Public Health Notifications. The Company denies any allegations against it and intends to continue to vigorously defend itself.
In addition to claims made directly against the Company, Coloplast, a distributor of TSM’s and certain allografts processed and private labeled for them under a contract with the Company, has also been named as a defendant in individual TSM cases in various federal and state courts. Coloplast requested that the Company indemnify or defend Coloplast in those claims which allege injuries caused by the Company’s allograft implants, and on April 24, 2014, Coloplast sued RTI Surgical, Inc. in the Fourth Judicial District of Minnesota for declaratory relief and breach of contract. On December 11, 2014, Coloplast entered into a settlement agreement with RTI Surgical, Inc. and Tutogen Medical, Inc. (the “Company Parties”) resulting in dismissal of the case. Under the terms of the settlement agreement, the Company Parties are responsible for the defense and indemnification of two categories of present and future claims: (1) tissue only (where Coloplast is solely the distributor of Company processed allograft tissue and no Coloplast-manufactured or distributed synthetic mesh is identified) (“Tissue Only Claims”), and (2) tissue plus non-Coloplast synthetic mesh (“Tissue-Non-Coloplast Claims”) (the Tissue Only Claims and the Tissue-Non-Coloplast Claims being collectively referred to as “Indemnified Claims”). As of September 30, 2019, there are a cumulative total of 1,113 Indemnified Claims for which the Company Parties are providing defense and indemnification. The defense and indemnification of these cases are covered under the Company’s insurance policy subject to a reservation of rights by the insurer.
22
Based on the current information available to the Company, the impact that current or any future TSM litigation may have on the Company cannot be reasonably estimated.
LifeNet — On June 27, 2018, LifeNet Health, Inc. (“LifeNet”) filed a patent infringement lawsuit in the United States District Court for the Middle District of Florida (since moved to the Northern District of Florida) claiming infringement of five of its patents by the Company. The suit requests damages, enhanced damages, reimbursement of costs and expenses, reasonable attorney fees, and an injunction. The asserted patents are now expired. On April 7, 2019, the Court granted the Company’s request to stay the lawsuit pending the U.S. Patent Trial and Appeal Board’s (PTAB) decision whether to institute review of the patentability of LifeNet’s patents. On August 12, 2019 the PTAB instituted review of three LifeNet patents, and on September 3 the PTAB instituted review of the remaining two. Final decisions with respect to the patentability of LifeNet’s patents (which may be appealed by either party) is expected to take place in the second half of 2020. The Company continues to believe the suit is without merit and will vigorously defend its position.
The Company’s accounting policy is to accrue for legal costs as they are incurred.
During the third quarter of 2018, the Company decided to stop procurement, manufacturing and distributing its map3® implants effective October 31, 2018. The map3® product has been either sold or destroyed and is off the market. In April 2019, the Company received a letter from the FDA indicating that no further corrective actions are necessary with respect to its previously issued Warning Letter in connection with the map3® product.
The Company distributes human tissue, bovine and porcine animal tissue, metal and synthetic implants through various distribution channels. The Company operates in one reportable segment composed of four franchises: spine; sports; OEM and international. Discrete financial information is not available for these four franchises. The following table presents revenues from these four franchises for the three and nine months ended September 30, 2019 and 2018:
|
For the Three Months Ended
|
|
|
For the Nine Months Ended
|
|
|
September 30,
|
|
|
September 30,
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
|
(In thousands)
|
|
Revenues:
|
|
|
Spine
|
$
|
23,661
|
|
|
$
|
20,741
|
|
|
$
|
70,337
|
|
|
$
|
58,938
|
|
Sports
|
|
12,704
|
|
|
|
12,271
|
|
|
|
40,507
|
|
|
|
39,896
|
|
OEM
|
|
32,341
|
|
|
|
30,092
|
|
|
|
93,815
|
|
|
|
91,382
|
|
International
|
|
7,423
|
|
|
|
5,960
|
|
|
|
23,518
|
|
|
|
19,423
|
|
Total revenues
|
$
|
76,129
|
|
|
$
|
69,064
|
|
|
$
|
228,177
|
|
|
$
|
209,639
|
|
The following table presents percentage of total revenues derived from the Company’s largest distributors:
|
For the Three Months Ended
|
|
|
For the Nine Months Ended
|
|
|
September 30,
|
|
|
September 30,
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
Percent of revenues derived from:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Distributor
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Zimmer Biomet Holdings, Inc.
|
|
18
|
%
|
|
|
22
|
%
|
|
|
19
|
%
|
|
|
21
|
%
|
Medtronic, PLC
|
|
7
|
%
|
|
|
9
|
%
|
|
|
8
|
%
|
|
|
8
|
%
|
DePuy Synthes
|
|
4
|
%
|
|
|
3
|
%
|
|
|
4
|
%
|
|
|
5
|
%
|
The following table presents property, plant and equipment - net by significant geographic location:
|
September 30,
|
|
|
December 31,
|
|
|
2019
|
|
|
2018
|
|
Property, plant and equipment - net:
|
|
|
|
|
|
|
|
Domestic
|
$
|
75,211
|
|
|
$
|
72,501
|
|
International
|
|
5,995
|
|
|
|
5,453
|
|
Total
|
$
|
81,206
|
|
|
$
|
77,954
|
|
23
The Company evaluated subsequent events as of the issuance date of the condensed consolidated financial statements as defined by ASC 855 Subsequent Events, and identified no subsequent events that require adjustment to, or disclosure of, in these condensed consolidated financial statements.
24