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Commitments and Contingencies
9 Months Ended
Sep. 30, 2024
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies

Note 10 — Commitments and Contingencies

Litigation

 

The Company may be involved from time to time in legal proceedings, claims and assessments arising from the ordinary course of business. Such matters are subject to many uncertainties, and outcomes are not predictable with assurance. During 2022, a former employee who was terminated in 2021 brought an age discrimination claim against the Company. During the fourth quarter of 2023, the Company settled the claim with the former employee. The Company deemed it probable that its insurance company would pay its share of the claim. As a result of this assumed gain contingency, the Company reduced its accrual to an amount that is not expected to be covered by insurance, and recorded a liability of approximately $55,000 for severance and legal expenses as of December 31, 2023. The settlement was paid and all insurance proceeds were received during the three months ended March 31, 2024. There is no other material litigation against the Company at this time.

Operating Leases

 

The Company has a non-cancelable sublease agreement for its corporate headquarters in Boston, Massachusetts, which expires in January 2025 and a lease agreement for office space in Fort Worth, TX. which expires in December 2025. In August 2024, the Company entered into a new lease agreement for its new corporate headquarters and manufacturing facility in Burlington, Massachusetts, which the Company expects to begin occupying by the end of 2024, with a term of approximately 88 months following the rent commencement date. The Company has the option to extend the new lease for an additional five years, subject to certain conditions being satisfied. Under the new lease, the Company provided a security deposit to the landlord in the form of a letter of credit for $375,000. The Company has collateralized the letter of credit with cash in a separate bank account, which is accounted for as long-term restricted cash on the condensed consolidated balance sheet. Termination options are either not included, or have expired, for the Company’s other existing operating leases. Certain arrangements have discounted rent periods or escalating rent payment provisions. Leases with an initial term of twelve months or less are not recorded on the condensed consolidated balance sheets. We recognize rent expense on a straight-line basis over the lease term.

 

As of September 30, 2024, operating lease assets were approximately $467,000. The amount and the maturity of the Company’s operating lease liabilities as of September 30, 2024, are as follows:

 

 

 

 

 

 

 

 

 

September 30, 2024

 

2024

 

 

 

 

 

 

 

$

144,610

 

2025

 

 

 

 

 

 

 

 

102,841

 

2026

 

 

 

 

 

 

 

 

 

2027

 

 

 

 

 

 

 

 

 

Thereafter

 

 

 

 

 

 

 

 

 

Total future minimum lease payments

 

 

 

 

 

 

 

 

247,451

 

Less imputed interest

 

 

 

 

 

 

 

 

12,822

 

Total operating lease liabilities

 

 

 

 

 

 

 

$

234,629

 

Included in the condensed consolidated balance sheet:

 

 

 

 

 

 

 

 

 

Current operating lease liabilities

 

 

 

 

 

 

 

$

205,464

 

Non-current operating lease liabilities

 

 

 

 

 

 

 

 

29,165

 

Total operating lease liabilities

 

 

 

 

 

 

 

$

234,629

 

 

For the three and nine months ended September 30, 2024 and 2023, the total lease cost is comprised of the following amounts:

 

 

 

For the Three Months
Ended September 30,

 

 

For the Nine Months
Ended September 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Operating lease expense

 

$

87,836

 

 

$

116,314

 

 

$

263,506

 

 

$

367,613

 

Short-term lease expense

 

 

1,615

 

 

 

-

 

 

 

4,884

 

 

 

-

 

Total lease expense

 

$

89,451

 

 

$

116,314

 

 

$

268,390

 

 

$

367,613

 

 

The following summarizes additional information related to operating leases:

 

 

 

 

 

 

 

September 30, 2024

 

 

December 31, 2023

 

Weighted-average remaining lease term (in years)

 

 

 

 

 

 

0.54

 

 

 

1.20

 

Weighted-average discount rate

 

 

 

 

 

 

23.3

%

 

 

23.3

%

Major Customers

For the three and nine months ended September 30, 2024 and 2023, there were no customers which accounted for more than 10% of product revenues. For the three and nine months ended September 30, 2024 and 2023, a U.S. insurance payer represented 19% and 22% and 36% and 40% of product revenues, respectively. For the three and nine months ended September 30, 2024, patients with Medicare Part B coverage represented 55% and 44% of product revenues, respectively.

For the three and nine months ended September 30, 2024, approximately 24% and 27% of the Company's product revenues, respectively, were derived from patients with Medicare Advantage insurance plans. For the three and nine months ended September 30, 2023, approximately 59% and 59% of the Company's product revenues were derived from patients with Medicare advantage plans, respectively.

 

At September 30, 2024 and December 31, 2023, one insurance payer and its affiliates accounted for approximately 25% and 56% of accounts receivable, respectively.

Supplier Finance Program Obligations

 

The Company finances its Directors and Officers Insurance policy, which requires the Company to make a down payment, followed by equal payments over a defined term. During the year ended December 31, 2023, the Company completed its payment obligation associated with its 2022-2023 policy and entered into a new policy covering the twelve-month period ending June 2024. Under this financing arrangement, the Company made a down payment of approximately $29,000 during the three months ended June 30, 2023 and made nine equal monthly payments of approximately $27,000, starting in July 2023. During the nine months ended September 30, 2024, the Company completed its payment obligation associated with its 2023-2024 policy and entered into a new policy covering the twelve-month period ending June 2025. Under this new financing arrangement, the Company made a down payment of approximately $39,000 during the three months ended June 30,

2024, and is making nine equal monthly payments of approximately $39,000, starting in July 2024. Changes in the Company's supplier finance obligations were as follows:

 

 

 

 

 

 

For the Nine Months Ended September 30,

 

2024

 

 

2023

 

Balance January 1

 

$

142,217

 

 

$

56,603

 

Increase

 

 

 

 

 

128,692

 

Expensed

 

 

(80,109

)

 

 

(132,988

)

Balance March 31,

 

$

62,108

 

 

$

52,307

 

Increase

 

 

349,909

 

 

 

375,824

 

Expensed

 

 

(78,593

)

 

 

(155,076

)

Balance June 30,

 

$

333,424

 

 

$

273,055

 

Increase

 

 

63,478

 

 

 

29,809

 

Expensed

 

 

(121,512

)

 

 

(80,538

)

Balance September 30,

 

$

275,390

 

 

$

222,326

 

 

No assets are pledged as security under this arrangement.