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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 10-Q

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2024

Or

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to .

Commission file number: 000-50865

MannKind Corporation

(Exact name of registrant as specified in its charter)

Delaware

13-3607736

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

 

 

1 Casper Street

Danbury, Connecticut

06810

(Address of principal executive offices)

(Zip Code)

(818) 661-5000

(Registrant’s telephone number, including area code)

N/A

(Former name, former address and former fiscal year, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common Stock, par value $0.01 per share

 

MNKD

 

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

Accelerated filer

 

 

 

 

Non-accelerated filer

Smaller reporting company

 

 

 

 

 

 

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No ☒

As of April 26, 2024, there were 272,315,846 shares of the registrant’s common stock, $0.01 par value per share, outstanding.

 

 


 

MANNKIND CORPORATION

Form 10-Q

For the Quarterly Period Ended March 31, 2024

TABLE OF CONTENTS

 

Page

PART I: FINANCIAL INFORMATION

2

 

 

Item 1. Financial Statements (Unaudited)

2

Condensed Consolidated Statements of Operations: Three months ended March 31, 2024 and 2023

2

Condensed Consolidated Balance Sheets: March 31, 2024 and December 31, 2023

3

Condensed Consolidated Statements of Stockholders’ Deficit: Three months ended March 31, 2024 and 2023

4

Condensed Consolidated Statements of Cash Flows: Three months ended March 31, 2024 and 2023

5

Notes to Condensed Consolidated Financial Statements

6

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

33

Item 3. Quantitative and Qualitative Disclosures About Market Risk

39

Item 4. Controls and Procedures

39

 

 

PART II: OTHER INFORMATION

40

 

 

Item 1. Legal Proceedings

40

Item 1A. Risk Factors

40

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

69

Item 3. Defaults Upon Senior Securities

69

Item 4. Mine Safety Disclosures

69

Item 5. Other Information

69

Item 6. Exhibits

70

 

 

SIGNATURES

71

 

 

 

1


 

PART 1: FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

MANNKIND CORPORATION AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

 

Three Months
Ended March 31,

 

 

 

2024

 

 

2023

 

 

 

(In thousands except per share data)

 

Revenues:

 

 

 

 

 

 

Net revenue – commercial product sales

 

$

18,764

 

 

$

17,562

 

Revenue – collaborations and services

 

 

24,848

 

 

 

11,386

 

Royalties – collaborations

 

 

22,651

 

 

 

11,678

 

Total revenues

 

 

66,263

 

 

 

40,626

 

Expenses:

 

 

 

 

 

 

Cost of goods sold

 

 

3,819

 

 

 

5,530

 

Cost of revenue – collaborations and services

 

 

14,779

 

 

 

10,683

 

Research and development

 

 

10,013

 

 

 

5,605

 

Selling

 

 

11,601

 

 

 

13,310

 

General and administrative

 

 

10,728

 

 

 

10,542

 

(Gain) loss on foreign currency transaction

 

 

(1,399

)

 

 

954

 

Total expenses

 

 

49,541

 

 

 

46,624

 

Income (loss) from operations

 

 

16,722

 

 

 

(5,998

)

Other income (expense):

 

 

 

 

 

 

Interest income, net

 

 

3,434

 

 

 

1,302

 

Interest expense on financing liability

 

 

(2,447

)

 

 

(2,424

)

Interest expense

 

 

(2,567

)

 

 

(2,786

)

Interest expense on liability for sale of future royalties

 

 

(4,248

)

 

 

 

Other income

 

 

 

 

 

111

 

Total other expense

 

 

(5,828

)

 

 

(3,797

)

Income (loss) before income tax expense

 

 

10,894

 

 

 

(9,795

)

Income tax expense

 

 

264

 

 

 

 

Net income (loss)

 

$

10,630

 

 

$

(9,795

)

Net income (loss) per share – basic

 

$

0.04

 

 

$

(0.04

)

Weighted average shares used to compute net income (loss)
per share – basic

 

 

270,356

 

 

 

263,969

 

Net income (loss) per share – diluted

 

$

0.04

 

 

$

(0.04

)

Weighted average shares used to compute net income (loss)
per share – diluted

 

 

324,733

 

 

 

263,969

 

 

See notes to condensed consolidated financial statements.

2


 

MANNKIND CORPORATION AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

 

 

 

 

 

 

 

 

March 31, 2024

 

 

December 31, 2023

 

 

 

(In thousands except share
and per share data)

 

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

193,272

 

 

$

238,480

 

Short-term investments

 

 

107,457

 

 

 

56,619

 

Accounts receivable, net

 

 

19,912

 

 

 

14,901

 

Inventory

 

 

26,442

 

 

 

28,545

 

Prepaid expenses and other current assets

 

 

36,019

 

 

 

34,848

 

Total current assets

 

 

383,102

 

 

 

373,393

 

Property and equipment, net

 

 

83,620

 

 

 

84,220

 

Goodwill

 

 

1,931

 

 

 

1,931

 

Other intangible asset

 

 

1,053

 

 

 

1,073

 

Long-term investments

 

 

3,726

 

 

 

7,155

 

Other assets

 

 

7,447

 

 

 

7,426

 

Total assets

 

$

480,879

 

 

$

475,198

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' DEFICIT

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

7,149

 

 

$

9,580

 

Accrued expenses and other current liabilities

 

 

42,291

 

 

 

42,036

 

Financing liability – current

 

 

9,872

 

 

 

9,809

 

Midcap credit facility – current

 

 

20,000

 

 

 

20,000

 

Liability for sale of future royalties – current

 

 

10,537

 

 

 

9,756

 

Deferred revenue – current

 

 

7,601

 

 

 

9,085

 

Recognized loss on purchase commitments – current

 

 

2,446

 

 

 

3,859

 

Total current liabilities

 

 

99,896

 

 

 

104,125

 

Mann Group convertible note

 

 

8,829

 

 

 

8,829

 

Accrued interest – Mann Group convertible note

 

 

55

 

 

 

56

 

Financing liability – long term

 

 

94,207

 

 

 

94,319

 

Midcap credit facility – long term

 

 

8,105

 

 

 

13,019

 

Senior convertible notes

 

 

227,214

 

 

 

226,851

 

Liability for sale of future royalties – long term

 

 

137,418

 

 

 

136,054

 

Recognized loss on purchase commitments – long term

 

 

60,287

 

 

 

60,942

 

Operating lease liability

 

 

3,645

 

 

 

3,925

 

Deferred revenue – long term

 

 

67,741

 

 

 

69,794

 

Milestone liabilities

 

 

3,452

 

 

 

3,452

 

Total liabilities

 

 

710,849

 

 

 

721,366

 

Commitments and contingencies (Note 14)

 

 

 

 

 

 

Stockholders' deficit:

 

 

 

 

 

 

Undesignated preferred stock, $0.01 par value – 10,000,000 shares authorized;
no shares issued or outstanding as of March 31, 2024 or December 31, 2023

 

 

 

 

 

 

Common stock, $0.01 par value – 800,000,000 shares authorized;
   
270,801,781 and 270,034,495 shares issued and outstanding as of
   March 31, 2024 and December 31, 2023, respectively

 

 

2,703

 

 

 

2,700

 

Additional paid-in capital

 

 

2,986,104

 

 

 

2,980,539

 

Accumulated deficit

 

 

(3,218,777

)

 

 

(3,229,407

)

Total stockholders' deficit

 

 

(229,970

)

 

 

(246,168

)

Total liabilities and stockholders' deficit

 

$

480,879

 

 

$

475,198

 

 

See notes to condensed consolidated financial statements.

 

3


 

MANNKIND CORPORATION AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT

(Unaudited)

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Additional
Paid-in Capital

 

 

Accumulated Deficit

 

 

Total

 

 

 

(In thousands)

 

BALANCE, JANUARY 1, 2023

 

 

263,793

 

 

$

2,638

 

 

$

2,964,293

 

 

$

(3,217,469

)

 

$

(250,538

)

Issuance of common stock associated
   with at-the-market placement

 

 

269

 

 

 

3

 

 

 

1,196

 

 

 

 

 

 

1,199

 

Issuance costs associated with at-the-market
   placement

 

 

 

 

 

 

 

 

(24

)

 

 

 

 

 

(24

)

Net issuance of common stock associated
   with stock options and restricted stock units

 

206

 

 

 

2

 

 

 

50

 

 

 

 

 

 

52

 

Issuance of common stock pursuant to
   conversion of the Mann Group
   convertible note interest

 

 

11

 

 

 

 

 

 

55

 

 

 

 

 

 

55

 

Stock-based compensation expense

 

 

 

 

 

 

 

3,655

 

 

 

 

 

 

3,655

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(9,795

)

 

 

(9,795

)

BALANCE, MARCH 31, 2023

 

 

264,279

 

 

$

2,643

 

 

$

2,969,225

 

 

$

(3,227,264

)

 

$

(255,396

)

 

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Additional
Paid-in Capital

 

 

Accumulated Deficit

 

 

Total

 

 

 

(In thousands)

 

BALANCE, JANUARY 1, 2024

 

 

270,034

 

 

$

2,700

 

 

$

2,980,539

 

 

$

(3,229,407

)

 

$

(246,168

)

Issuance of common stock pursuant to
   conversion of the Mann Group
   convertible note interest

 

 

15

 

 

 

 

 

 

56

 

 

 

 

 

 

56

 

Net issuance of common stock associated
   with stock options and restricted stock units

 

337

 

 

 

3

 

 

 

263

 

 

 

 

 

 

266

 

Issuance of common stock from market
     price stock purchase plan

 

 

416

 

 

 

 

 

 

1,361

 

 

 

 

 

 

1,361

 

Stock-based compensation expense

 

 

 

 

 

 

 

3,885

 

 

 

 

 

 

3,885

 

Net income

 

 

 

 

 

 

 

 

 

 

 

10,630

 

 

 

10,630

 

BALANCE, MARCH 31, 2024

 

 

270,802

 

 

$

2,703

 

 

$

2,986,104

 

 

$

(3,218,777

)

 

$

(229,970

)

 

See notes to condensed consolidated financial statements.

4


 

MANNKIND CORPORATION AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

 

Three Months Ended March 31,

 

 

 

2024

 

 

2023

 

 

 

(In thousands)

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

 

Net income (loss)

 

$

10,630

 

 

$

(9,795

)

Adjustments to reconcile net income (loss) to net cash provided by
   operating activities:

 

 

 

 

 

 

Interest on liability for sale of future royalties

 

 

4,248

 

 

 

 

Stock-based compensation

 

 

3,885

 

 

 

3,655

 

Depreciation and amortization

 

 

1,361

 

 

 

1,058

 

Loss on estimated returns of acquired product

 

 

1,169

 

 

 

 

Write-off of inventory

 

 

1,029

 

 

 

2,416

 

Amortization of debt discount and issuance costs

 

 

501

 

 

 

469

 

Amortization of right-of-use assets

 

 

328

 

 

 

338

 

Interest on Mann Group convertible note

 

 

55

 

 

 

55

 

Other, net

 

 

49

 

 

 

61

 

(Gain) loss on foreign currency transaction

 

 

(1,399

)

 

 

954

 

Net accretion of investments

 

 

(984

)

 

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Accounts receivable, net

 

 

(5,456

)

 

 

(2,913

)

Inventory

 

 

1,074

 

 

 

(2,641

)

Prepaid expenses and other current assets

 

 

(3,274

)

 

 

2,426

 

Other assets

 

 

(314

)

 

 

 

Accounts payable

 

 

(2,431

)

 

 

2,837

 

Accrued expenses and other current liabilities

 

 

670

 

 

 

(3,562

)

Deferred revenue

 

 

(3,537

)

 

 

8,558

 

Recognized loss on purchase commitments

 

 

(669

)

 

 

(2,074

)

Operating lease liabilities

 

 

(232

)

 

 

(686

)

Net cash provided by operating activities

 

 

6,703

 

 

 

1,156

 

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

 

Proceeds from held-to-maturity debt securities

 

 

21,974

 

 

 

22,103

 

Purchase of held-to-maturity debt securities

 

 

(68,399

)

 

 

 

Purchase of property and equipment

 

 

(2,408

)

 

 

(8,311

)

Proceeds from insurance claim

 

 

396

 

 

 

 

Net cash (used in) provided by investing activities

 

 

(48,437

)

 

 

13,792

 

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

 

Proceeds from market price stock purchase plan

 

 

1,361

 

 

 

 

Payments for taxes related to net issuance of common stock associated with
   restricted stock units and stock options

 

 

266

 

 

 

52

 

Principal payment on financing liability

 

 

(101

)

 

 

(72

)

Principal payment on MidCap credit facility

 

 

(5,000

)

 

 

 

Proceeds from at-the-market-offering

 

 

 

 

 

1,198

 

Issuance costs associated with at-the-market offering

 

 

 

 

 

(24

)

Net cash (used in) provided by financing activities

 

 

(3,474

)

 

 

1,154

 

NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS

 

 

(45,208

)

 

 

16,102

 

CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD

 

 

238,480

 

 

 

69,767

 

CASH AND CASH EQUIVALENTS, END OF PERIOD

 

$

193,272

 

 

$

85,869

 

 

 

 

Three Months Ended March 31,

 

 

 

2024

 

 

2023

 

 

 

(In thousands)

 

SUPPLEMENTAL CASH FLOWS DISCLOSURES:

 

 

 

 

 

 

   Interest paid in cash

 

$

5,931

 

 

$

3,700

 

NON-CASH INVESTING AND FINANCING ACTIVITIES:

 

 

 

 

 

 

Reclassification of Midcap credit facility from long-term to current

 

 

5,000

 

 

 

11,667

 

Reclassification of investments from long-term to current

 

 

4,653

 

 

 

1,468

 

Non-cash construction in progress, property and equipment

 

 

1,667

 

 

 

2,438

 

Reclassification of Thirona convertible notes and interest receivable
   from current to long-term

 

 

 

 

 

7,726

 

Right-of-use asset modification

 

 

 

 

 

728

 

Goodwill adjustment for a net reduction in liabilities

 

 

 

 

 

430

 

 

See notes to condensed consolidated financial statements.

5


 

MANNKIND CORPORATION AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

1. Description of Business and Significant Accounting Policies

The unaudited condensed consolidated financial statements of MannKind Corporation and its subsidiaries (“MannKind,” the “Company,” “we” or “us”), have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (the “SEC”). Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. The information included in this quarterly report on Form 10-Q should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 27, 2024 (the “Annual Report”).

In the opinion of management, all adjustments, consisting only of normal, recurring adjustments, considered necessary for a fair presentation of the results of these interim periods have been included. The results of operations for the three months ended March 31, 2024 may not be indicative of the results that may be expected for the full year.

Financial Statement Estimates — The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and notes. Actual results could differ from those estimates or assumptions. Management considers many factors in selecting appropriate financial accounting policies, and in developing the estimates and assumptions that are used in the preparation of the financial statements. Management must apply significant judgment in this process. These effects could have a material impact on the estimates and assumptions used in the preparation of the condensed consolidated financial statements. The more significant estimates include revenue recognition, including gross-to-net adjustments, stand-alone selling price considerations for recognition of collaboration revenue, assessing long-lived assets for impairment, clinical trial expenses, inventory costing and recoverability, recognized loss on purchase commitment, stock-based compensation, the determination of the provision for income taxes and corresponding deferred tax assets and liabilities, the valuation allowance recorded against net deferred tax assets, and expected cash flows from royalties received in connection with United Therapeutics' ("UT's") net revenue for the sale of Tyvaso DPI.

Business — MannKind is a biopharmaceutical company focused on the development and commercialization of innovative therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. The Company’s signature technologies—Technosphere dry-powder formulations and Dreamboat inhalation devices—offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation. The Company is currently commercializing Afrezza (insulin human) Inhalation Powder, an ultra rapid-acting inhaled insulin indicated to improve glycemic control in adults with diabetes, and the V-Go wearable insulin delivery device, which provides continuous subcutaneous infusion of insulin in adults that require insulin. The first product to come out of the orphan lung disease pipeline, Tyvaso DPI (treprostinil) inhalation powder, received approval from the U.S. Food and Drug Administration (“FDA”) in May 2022 for the treatment of pulmonary arterial hypertension (“PAH”) and for the treatment of pulmonary hypertension associated with interstitial lung disease (“PH-ILD”). The Company's development and marketing partner, UT, began commercializing Tyvaso DPI in June 2022 and is obligated to pay the Company a 10% royalty on net sales of the product. The Company also receives a margin on supplies of Tyvaso DPI that it manufactures for UT.

Basis of Presentation — The condensed consolidated financial statements have been prepared in accordance with GAAP.

Principles of Consolidation — The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. Intercompany balances and transactions have been eliminated.

Reclassifications — Certain amounts reported in the prior period have been reclassified to conform with current period presentation. The Company has presented non-cash interest accretion on financing liability on a net basis in Other, net, in the condensed consolidated statements of cash flows.

6


 

Segment Information — Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. To date, the Company has viewed its operations and manages its business as one segment operating in the United States of America.

Revenue Recognition — The Company recognizes revenue when its customers obtain control of promised goods or services, in an amount that reflects the consideration which the Company expects to be entitled in exchange for those goods or services.

To determine revenue recognition for arrangements that are within the scope of Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”), the Company performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to arrangements that meet the definition of a contract under ASC 606, including when it is probable that the entity will collect the consideration to which it is entitled in exchange for the goods or services it transfers to the customer.

At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company has two types of contracts with customers: (i) contracts for commercial product sales with wholesale distributors, specialty and retail pharmacies, and durable medical equipment suppliers ("DMEs") and (ii) collaboration arrangements.

Revenue Recognition — Net Revenue — Commercial Product Sales — The Company sells its products to a limited number of wholesale distributors, specialty and retail pharmacies, and DMEs in the U.S. (collectively, its “Customers”). Wholesale distributors subsequently resell the Company’s products to retail pharmacies and certain medical centers or hospitals. Specialty and retail pharmacies sell directly to patients. In addition to distribution agreements with Customers, the Company enters into arrangements with payers that provide for government mandated and/or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products.

The Company recognizes revenue on product sales when the Customer obtains control of the Company's product, which occurs at delivery for wholesale distributors and generally at delivery for specialty pharmacies. The Company recognizes revenue on product sales to a retail pharmacy as the product is dispensed to patients. Product revenues are recorded net of applicable reserves, including discounts, allowances, rebates, returns and other incentives. See Reserves for Variable Consideration below.

Reserves for Variable Consideration — Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established. Components of variable consideration include trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, payer rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its Customers, payers, and other indirect customers relating to the Company’s sale of its products. These reserves, as further detailed below, are based on the amounts earned, or to be claimed on the related sales, and result in a reduction of accounts receivable or establishment of a current liability. Significant judgment is required in estimating gross-to-net adjustments, including historical experience, payer channel mix, current contract prices under applicable programs, unbilled claims, claim submission time lags and inventory levels in the distribution channel.

Where appropriate, these estimates take into consideration a range of possible outcomes, which are probability-weighted in accordance with the expected value method in ASC 606 for relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. Overall, these reserves reduce recognized revenue to the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts.

The amount of variable consideration that is included in the transaction price may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. The Company’s analysis also contemplates application of the constraint in accordance with the guidance, under which it determined a material reversal of revenue would not occur in a future period for the current period estimates of gross-to-net adjustments and, therefore, the transaction price was not reduced further during the current period. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net revenue from commercial product sales and earnings in the period such variances become known.

Trade Discounts and Allowances — The Company generally provides Customers with discounts which include incentives, such as prompt pay discounts, that are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the

7


 

related product revenue is recognized. In addition, the Company compensates (through trade discounts and allowances) its Customers for sales order management, data, and distribution services. However, the Company has determined such services received to date are not distinct from the Company’s sale of products to the Customer and, therefore, these payments have been recorded as a reduction of revenue and as a reduction to accounts receivable, net.

Product Returns — Consistent with industry practice, the Company generally offers Customers a right of return for unopened product that has been purchased from the Company for a period beginning six months prior to and ending 12 months after its expiration date, which lapses upon shipment to a patient. The Company estimates the amount of its product sales that may be returned by its Customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized, as well as reductions to accounts receivable, net. The Company currently estimates product returns using available industry data and its own sales information, including its visibility into the inventory remaining in the distribution channel. The Company’s current return reserve percentage is estimated to be in the single digits. Adjustments to the returns reserve are made when changes in the Company's assumptions result in revised estimates.

Provider Chargebacks and Discounts — Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase products from the Company. Customers charge the Company for the difference between what they pay for products and the ultimate selling price to the qualified healthcare providers. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability that is recorded in accrued expenses and other current liabilities. Chargeback amounts are generally determined at the time of resale to the qualified healthcare provider by Customers, and the Company generally issues credits for such amounts within a few weeks of the Customer’s notification to the Company of the resale. Reserves for chargebacks consist of credits that the Company expects to issue for units that remain in the distribution channel inventories at each reporting period-end that the Company expects will be sold to qualified healthcare providers, and chargebacks that Customers have claimed, but for which the Company has not yet issued a credit.

Government Rebates — The Company is subject to discount obligations under Medicare and state Medicaid programs. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability that is included in accrued expenses and other current liabilities. Estimates around Medicaid have historically required significant judgment due to timing lags in receiving invoices for claims from states. For Afrezza, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for products that have been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period. The Company’s estimates include consideration of historical claims experience, payer channel mix, current contract prices, unbilled claims, claim submission time lags and inventory in the distribution channel.

Payer Rebates — The Company contracts with certain private payer organizations, primarily insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of its products. The Company estimates these rebates, including estimates for product that has been recognized as revenue, but which remains in the distribution channel, and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities. The Company’s estimates include consideration of historical claims experience, payer channel mix, current contract prices, unbilled claims, claim submission time lags and inventory in the distribution channel.

Other Incentives — Other incentives which the Company offers include voluntary patient support programs, such as the Company's co-pay assistance program, which are intended to provide financial assistance to qualified commercially-insured patients with co-payments required by payers. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with the products that have been recognized as revenue but remains in the distribution channel inventories at the end of each reporting period. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability that is included in accrued expenses and other current liabilities.

8


 

Revenue Recognition — Revenue — Collaborations and Services — The Company enters into licensing, research or other agreements under which the Company licenses certain rights to its product candidates to third parties, conducts research or provides other services to third parties. The terms of these arrangements may include but are not limited to payment to the Company of one or more of the following: up-front license fees; development, regulatory, and commercial milestone payments; payments for commercial manufacturing and clinical supply services the Company provides; and royalties on net sales of licensed products and sublicenses of the rights. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment such as determining the performance obligation in the contract and determining the stand-alone selling price for each performance obligation identified in the contract. With respect to the Company's significant collaboration and service agreement with UT that includes a long-term commercial supply agreement (as amended, the “CSA”), the Company has identified three distinct performance obligations: (1) the license, supply of product to be used in clinical development, and continued development and approval support for Tyvaso DPI (“R&D Services and License”); (2) development activities for the next generation of the product (“Next-Gen R&D Services”); and (3) a material right associated with current and future manufacturing and supply of product (“Manufacturing Services and Product Sales”). Pre-production activities under the CSA, such as facility expansion services and other administrative services, were considered bundled services under the Manufacturing Services and Product Sales performance obligation as required by ASC 606. Following the FDA’s approval of Tyvaso DPI, UT began issuing purchase orders for the supply of product, which represents distinct contracts and performance obligations under ASC 606. Revenue is recognized for the supply of product at a point in time, once control is transferred to UT. See Note 9 – Collaboration, Licensing and Other Arrangements.

If an arrangement has multiple performance obligations, the allocation of the transaction price is determined from observable market inputs, and the Company uses key assumptions to determine the stand-alone selling price, which may include development timelines, reimbursement rates for personnel costs, discount rates, and probabilities of technical and regulatory success. Revenue is recognized based on the measurement of progress as the performance obligation is satisfied and consideration received that does not meet the requirements to satisfy the revenue recognition criteria is recorded as deferred revenue. Current deferred revenue consists of amounts that are expected to be recognized as revenue in the next 12 months. Amounts that the Company expects will not be recognized within the next 12 months are classified as long-term deferred revenue. For further information, see Note 9 – Collaboration, Licensing and Other Arrangements.

The Company recognizes upfront license payments as revenue upon delivery of the license only if the license is determined to be a separate unit of accounting from the other undelivered performance obligations. The undelivered performance obligations typically include manufacturing or development services or research and/or steering committee services. If the license is not considered as a distinct performance obligation, then the license and other undelivered performance obligations would be evaluated to determine if such should be accounted for as a single unit of accounting. If concluded to be a single performance obligation, the transaction price for the single performance obligation is recognized as revenue over the estimated period of when the performance obligation is satisfied. If the license is considered to be a distinct performance obligation, then the estimated revenue is included in the transaction price for the contract, which is then allocated to each performance obligation based on the respective standalone selling prices.

Whenever the Company determines that an arrangement should be accounted for over time, the Company determines the period over which the performance obligations will be performed, and revenue will be recognized over the period the Company is expected to complete its performance obligations. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which the Company is expected to complete its performance obligations under an arrangement.

The Company’s collaboration agreements typically entitle the Company to additional payments upon the achievement of development, regulatory and sales milestones. If the achievement of a milestone is considered probable at the inception of the collaboration, the related milestone payment is included with other collaboration consideration, such as upfront fees and research funding, in the Company’s revenue calculation. If these milestones are not considered probable at the inception of the collaboration, the milestones will typically be recognized in one of two ways depending on the timing of when the milestone is achieved. If the milestone is improbable at inception and subsequently deemed probable of achievement, such will be added to the transaction price, resulting in a cumulative adjustment to revenue. If the milestone is achieved after the performance period has been completed and all performance obligations have been delivered, the Company will recognize the milestone payment as revenue in its entirety in the period the milestone was achieved.

The Company’s collaboration agreements, for accounting purposes, represent contracts with customers and therefore are not subject to accounting literature on collaboration agreements. The Company grants licenses to its intellectual property, supplies raw materials, semi-finished goods or finished goods, provides research and development services and offers sales support for the co-promotion of products, all of which are outputs of the Company’s ongoing activities, in exchange for consideration. Accordingly, the Company concluded that its collaboration agreements must generally be accounted for pursuant to ASC 606.

For collaboration agreements that allow collaboration partners to select additional optioned products or services, the Company evaluates whether such options contain material rights (i.e., have exercise prices that are discounted compared to what the Company

9


 

would charge for a similar product or service to a new collaboration partner). The exercise price of these options includes a combination of licensing fees, event-based milestone payments and royalties. When these amounts in aggregate are not offered at a discount that exceeds discounts available to other customers, the Company concludes the option does not contain a material right, and therefore is not included in the transaction price at contract inception. The Company assessed the long-term commercial supply agreement with UT (as amended, the "CSA") and determined that a material right existed for the manufacturing services performance obligation. The transaction price is allocated to the material right as well as the remaining performance obligations in accordance with ASC 606. The Company also evaluates grants of additional licensing rights upon option exercises to determine whether such should be accounted for as separate contracts.

Revenue Recognition — Royalties — The Company recognizes royalty revenue for a sales-based or usage-based royalty if it is promised in exchange for an intellectual property license. The royalty revenue is recognized as the latter of the subsequent sale of the product occurs or if the performance obligation to which the royalty has been allocated has been satisfied or partially satisfied. The Company’s UT License Agreement (as defined in Note 9 Collaboration, Licensing and Other Arrangements) entitles it to receive a 10% royalty on net sales of Tyvaso DPI for the license of the Company’s IP that was considered to be interdependent with the development activities that supported the approval of Tyvaso DPI. Although the Company recognizes a 10% royalty on net revenue from the sale of Tyvaso DPI as revenue, it will only collect 9% of future royalties due to its sale of 1% of future royalties in December 2023 as detailed in Note 14 Commitments and Contingencies.

The Company’s net revenue and cost of revenue and goods sold as shown on the condensed consolidated statement of operations is comprised of revenue generated from product sales, services and royalties as shown below (in thousands):

 

 

Three Months
Ended March 31,

 

 

 

2024

 

 

2023

 

Net revenue:

 

 

 

 

 

 

Product revenue (1)

 

$

43,228

 

 

$

28,726

 

Services (2)

 

 

384

 

 

 

222

 

Royalties (3)

 

 

22,651

 

 

 

11,678

 

Total net revenue

 

$

66,263

 

 

$

40,626

 

_________________________

(1)
Amounts represent the revenue from Afrezza and V-Go sales to wholesalers and specialty pharmacies and Tyvaso DPI to UT.
(2)
Amounts represent revenue generated from the Company's collaboration arrangements, including Next-Gen R&D Services (as defined in Note 9) for UT as well as arrangements with other collaboration partners. See Note 9 – Collaboration, Licensing and Other Arrangements.
(3)
Amounts represent royalties on UT’s net revenue from Tyvaso DPI sales.

 

 

Three Months
Ended March 31,

 

 

 

2024

 

 

2023

 

Cost of goods sold and cost of revenue:

 

 

 

 

 

 

Product revenue

 

$

18,598

 

 

$

16,028

 

Services

 

 

 

 

 

185

 

Total cost of goods sold and cost of revenue

 

$

18,598

 

 

$

16,213

 

The Company follows accounting guidance in measuring revenue and certain judgments affect the application of its revenue policy. For example, in connection with its existing collaboration agreements, the Company has recorded on its condensed consolidated balance sheets short-term and long-term deferred revenue based on its best estimate of when such revenue will be recognized. Short-term deferred revenue consists of amounts that are expected to be recognized as revenue in the next 12 months. Amounts that the Company expects will not be recognized within the next 12 months are classified as long-term deferred revenue. However, this estimate is based on the Company’s current project development plan and, if the development plan should change in the future, the Company may recognize a different amount of deferred revenue over the next 12-month period.

Milestone Payments At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the customer, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as, or when, the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company will re-evaluate the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its

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estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration, other revenue, and earnings in the period of adjustment.

Cost of Goods Sold — Cost of goods sold includes material, labor costs and manufacturing overhead. Cost of goods sold also includes a component of current period manufacturing costs in excess of costs capitalized into inventory (“excess capacity costs”). These costs, in addition to the impact of the revaluation of inventory for standard costing, and write-offs of inventory are recorded as expenses in the period in which they are incurred, rather than as a portion of inventory costs. Cost of goods sold excludes the cost of insulin purchased under the Company’s Insulin Supply Agreement (the “Insulin Supply Agreement”) with Amphastar Pharmaceuticals, Inc. (“Amphastar”). All insulin inventory on hand was written off and the full purchase commitment contract to purchase future insulin was accrued as a recognized loss on purchase commitments as of the end of 2016.

Cost of Revenues Collaborations and Services — Cost of revenues for collaborations and services includes material, labor costs, manufacturing overhead, and excess capacity costs. These costs, in addition to the write-offs of inventory are recorded as expenses in the period in which they are incurred, rather than as a portion of inventory costs. Cost of revenues for collaborations and services also includes the cost of product development.

Research and Development ("R&D") — Clinical trial expenses result from obligations under contracts with vendors, consultants and clinical site agreements in addition to internal costs associated with conducting clinical trials. R&D costs are expensed as incurred. Clinical study and certain research costs are recognized over the service periods specified in the contracts and adjusted as necessary based upon an ongoing review of the level of effort and costs actually incurred. Nonrefundable advance payments for services to be received in the future for use in R&D activities are recorded as prepaid assets and expensed in the period when the services are performed.

Cash and Cash Equivalents — The Company considers all highly liquid investments with original or remaining maturities of 90 days or less at the time of purchase, that are readily convertible into cash to be cash equivalents. As of March 31, 2024 and December 31, 2023, cash equivalents were comprised of money market funds, U.S. Treasury securities, corporate bonds and commercial paper with original maturities less than 90 days from the date of purchase.

Held-to-Maturity Investments — The Company’s investments generally consisted of commercial paper, corporate notes or bonds and U.S. Treasury securities. As of March 31, 2024 and December 31, 2023, the Company held short-term and long-term investments of debt securities, including commercial paper and bonds. The Company assesses whether it has any intention to sell the investment before maturity, whether any declines in fair value are the result of credit losses, as well as whether there were other-than-temporary impairments associated with the available-for-sale investment. The Company intends to hold its investments until maturity; therefore, these investments are stated at amortized cost. The investments with maturities less than 12 months are included in short-term investments and investments with maturities in excess of twelve months are included in long-term investments in the condensed consolidated balance sheets. The amortization or accretion of the Company’s investments is recognized as interest income in the condensed consolidated statements of operations.

Available-for-Sale Investment — In June 2021, the Company purchased a $3.0 million convertible promissory note (the “Thirona convertible note”) issued by Thirona Bio, Inc. (“Thirona”). In January 2022, the Company purchased an additional $5.0 million convertible promissory note issued by Thirona. Unless earlier converted into conversion shares pursuant to the note purchase agreement, the aggregate principal of $8.0 million and accrued interest shall be due and payable by Thirona on demand by the Company at any time after the maturity date. The Thirona convertible notes were amended in February 2023 to extend the maturity date from December 31, 2022 to June 30, 2024. The Thirona convertible notes are general unsecured obligations of Thirona and accrue interest at a rate of 6% per annum. The Thirona convertible notes are classified as available-for-sale securities and are included in prepaid expenses and other current assets in the condensed consolidated balance sheets. The Company periodically assesses whether it has any intention to sell the investment, determines the fair value of its available-for-sale investments using level 3 inputs and assesses whether there were other-than-temporary impairments associated with the investment. Unrealized holding gains and losses are excluded from earnings and reported in other comprehensive income until realized, while unrealized losses related to credit risk are reported through earnings in the period incurred. In June 2021, the Company and Thirona also entered into a collaboration agreement to develop a compound for the treatment of fibrotic pulmonary diseases. See Note 9 – Collaboration, Licensing and Other Arrangements.

Concentration of Credit Risk — Financial instruments that potentially subject the Company to concentration of credit risk consisted of cash and cash equivalents and investments. Cash and cash equivalents are held in high credit quality institutions. Cash equivalents consisted of interest-bearing money market funds and U.S. Treasury securities with original or remaining maturities of 90 days or less at the time of purchase. Investments generally consisted of commercial paper, corporate notes or bonds and U.S. Treasury securities. The cash equivalents and investments are regularly monitored by management.

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Accounts Receivable and Allowance for Credit Losses — Accounts receivable are recorded at the invoiced amount and are not interest bearing. Accounts receivable are presented net of an allowance for credit losses if there are estimated losses resulting from the inability of its customers to make required payments. The Company makes ongoing assumptions relating to the collectability of its accounts receivable in its calculation of the allowance for credit losses. The allowance for expected credit losses is based primarily on past collections experience relative to the length of time receivables are past due. However, when available evidence reasonably supports an assumption that future economic conditions will differ from current and historical payment collections, an adjustment is reflected in the allowance for expected credit losses. Accounts receivable are also presented net of an allowance for product returns and trade discounts and allowances because the Company’s customers have the right of setoff for these amounts against the related accounts receivable.

Pre-Launch Inventory — An improvement to the manufacturing process for the Company’s primary excipient, fumaryl diketopiperazine (“FDKP”) was demonstrated to be viable and management expects to realize an economic benefit in the future as a result of such process improvement. Accordingly, the Company is required to assess whether to capitalize inventory costs related to such excipient prior to validation of the improved manufacturing process and adoption of the new supplier. In doing so, management must consider a number of factors in order to determine the amount of inventory to be capitalized, including the historical experience of modifying the Company’s manufacturing processes, feedback from technical experts and regulatory agencies on the changes being effected and the amount of inventory that is likely to be used in commercial production. The shelf life of the excipient will be determined as part of the validation process; in the interim, the Company must assess the available stability data to determine whether there is likely to be adequate shelf life to support anticipated future sales occurring beyond the expected adoption date of the new raw material. If management is aware of any specific material risks or contingencies other than the normal regulatory reporting process, or if the criteria for capitalizing inventory produced prior to regulatory approval are otherwise not met, the Company would not capitalize such inventory costs, choosing instead to recognize such costs as R&D expense in the period incurred.

Inventories — Inventories are stated at the lower of cost or net realizable value. The Company determines the cost of inventory using the first-in, first-out, or FIFO, method. The Company capitalizes inventory costs associated with the Company’s products based on management’s judgment that future economic benefits are expected to be realized; otherwise, such costs are expensed as incurred as cost of goods sold. The Company uses a contract manufacturing organization outside of the U.S. for certain stages of V-Go inventory.

The Company periodically analyzes its inventory levels to identify inventory that may expire or has a cost basis in excess of its estimated realizable value and writes down such inventories, as appropriate. In addition, the Company’s products are subject to strict quality control and monitoring which the Company performs throughout the manufacturing process. If certain batches or units of product no longer meet quality specifications or may become obsolete or are forecasted to become obsolete due to expiration, the Company will record a charge to write down such unmarketable inventory to its estimated net realizable value. The Company analyzes its inventory levels to identify inventory that may expire or has a cost basis in excess of its estimated realizable value. The Company performs an assessment of projected sales and evaluates the lower of cost or net realizable value and the potential excess inventory on hand at the end of each reporting period.

Property and Equipment — Property and equipment is recorded at historical cost, net of accumulated depreciation. Depreciation expense is recorded over the assets’ useful lives on a straight-line basis. See Note 5 – Property and Equipment.

Impairment of Long-Lived Assets — Long-lived assets include property and equipment, operating lease right-of-use assets and other intangible assets. The Company evaluates long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. Assets are considered to be impaired if the carrying value is considered to be unrecoverable.

If the Company believes an asset to be impaired, the impairment recognized is the amount by which the carrying value of the asset exceeds the fair value of the asset. Fair value is determined using the market, income or cost approaches as appropriate for the asset. Any write-downs are treated as permanent reductions in the carrying amount of the asset and recognized as an operating loss.

Acquisitions — The Company first determines whether a set of assets acquired constitute a business and should be accounted for as a business combination. If the assets acquired do not constitute a business, the Company accounts for the transaction as an asset acquisition. Business combinations are accounted for by means of the acquisition method of accounting. Under the acquisition method, assets acquired, including in-process R&D (“IPR&D”) projects, and liabilities assumed are recorded at their respective fair values as of the acquisition date in the Company’s condensed consolidated financial statements. The excess of the fair value of consideration transferred over the fair value of the net assets acquired is recorded as goodwill. Contingent consideration obligations incurred in connection with a business combination (including the assumption of an acquiree’s liability arising from an acquisition it consummated prior to the Company’s acquisition) are recorded at their fair values on the acquisition date and remeasured at their fair values each subsequent reporting period until the related contingencies have been resolved. The resulting changes in fair values are recorded in earnings. In contrast, asset acquisitions are accounted for by using a cost accumulation and allocation model. Under this model, the cost of the acquisition is allocated to the assets acquired and liabilities assumed. IPR&D projects with no alternative future

12


 

use are recorded in R&D expense upon acquisition, and contingent consideration obligations incurred in connection with an asset acquisition are recorded when it is probable that they will occur and they can be reasonably estimated.

Goodwill and Other Intangible Assets — The fair value of acquired intangible assets is determined using an income-based approach referred to as the excess earnings method utilizing Level 3 fair value inputs. Market participant valuations assume a global view considering all potential jurisdictions and indications based on discounted after-tax cash flow projections, risk adjusted for estimated probability of technical and regulatory success.

The Company tests for impairment annually on a reporting unit basis, at the beginning of the Company’s fourth fiscal quarter and between annual tests if events and circumstances indicate it is more likely than not that the fair value of a reporting unit is less than its carrying amount. To the extent the carrying amount of a reporting unit is less than its estimated fair value, an impairment charge will be recorded.

Finite-lived intangible assets are amortized on a straight-line basis over the estimated useful life. Estimated useful lives are determined considering the period assets are expected to contribute to future cash flows. Finite-lived intangible assets are tested for impairment when facts or circumstances suggest that the carrying value of the asset may not be recoverable. If the carrying value exceeds the projected undiscounted pretax cash flows of the intangible asset, an impairment loss equal to the excess of the carrying value over the estimated fair value (discounted after-tax cash flows) is recognized.

Recognized Loss on Purchase Commitments — The Company reviews the terms of the long-term supply agreements and assesses the need for any accrual for estimated losses, such as lower of cost or net realizable value, that will not be recovered by future product sales. The recognized loss on purchase commitments is reduced as inventory items are received or as the liability is extinguished. See Note 14 – Commitments and Contingencies.

Milestone Rights Liability — In July 2013, in conjunction with the execution of a (now repaid) loan agreement with Deerfield Private Design Fund II, L.P. and Deerfield Private Design International II, L.P. (collectively, “Deerfield”), the Company entered into a Milestone Rights Purchase Agreement (the “Milestone Rights Agreement”) pursuant to which the Company issued certain milestone rights to Deerfield Private Design Fund II, L.P. and Horizon Santé FLML SÀRL (the “Original Milestone Purchasers”). The foregoing milestone rights provided the Original Milestone Purchasers certain rights to receive payments of up to $90.0 million upon the occurrence of specified strategic and Afrezza sales milestones, $55.0 million of which remains payable as of March 31, 2024 upon achievement of such milestones (collectively, the “Milestone Rights”). In December 2021, the Milestone Rights were purchased by Barings Global Special Situations Credit Fund 4 (Delaware), L.P. and Barings Global Special Situations Credit 4 (LUX) S.ar.l. (together the “Milestone Purchasers”). As a result, the Milestone Purchasers have assumed the obligations of the Original Milestone Purchasers and are now entitled to all rights under the Milestone Rights Agreement. The Milestone Rights liability is reported at fair value at the date of the agreement which is periodically offset against payments. See Note 10 – Fair Value of Financial Instruments.

The initial fair value estimate of the Milestone Rights was calculated using the income approach in which the cash flows associated with the specified contractual payments were adjusted for both the expected timing and the probability of achieving the milestones and discounted to present value using a selected market discount rate. The expected timing and probability of achieving the milestones was developed with consideration given to both internal data, such as progress made to date and assessment of criteria required for achievement, and external data, such as market research studies. The discount rate was selected based on an estimation of required rate of returns for similar investment opportunities using available market data. The Milestone Rights liability will be remeasured as the specified milestone events are achieved. Specifically, as each milestone event is achieved, the portion of the initially recorded Milestone Rights liability that pertains to the milestone event being achieved, will be remeasured to the amount of the specified related milestone payment. The resulting change in the balance of the Milestone Rights liability due to remeasurement will be recorded in the Company’s condensed consolidated statements of operations as interest expense. Furthermore, the Milestone Rights liability will be reduced upon the settlement of each milestone payment. As a result, each milestone payment would be effectively allocated between a reduction of the recorded Milestone Rights liability and an expense representing a return on a portion of the Milestone Rights liability paid to the investor for the achievement of the related milestone event. See Note 7 – Accrued Expenses and Other Current Liabilities and Note 14 – Commitments and Contingencies.

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Fair Value of Financial Instruments — The Company applies various valuation approaches in determining the fair value of its financial assets and liabilities within a hierarchy that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. The fair value hierarchy is broken down into three levels based on the source of inputs as follows:

Level 1 — Quoted prices for identical instruments in active markets.

Level 2 — Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable.

Level 3 — Significant inputs to the valuation model are unobservable.

Income Taxes — The provisions for federal, foreign, state and local income taxes are calculated on pre-tax income based on current tax law and include the cumulative effect of any changes in tax rates from those used previously in determining deferred tax assets and liabilities. Deferred income tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the year in which the temporary differences are expected to be recovered or settled. A valuation allowance is recorded to reduce net deferred income tax assets to amounts that are more likely than not to be realized.

For uncertain tax positions, the Company determines whether it is “more likely than not” that a tax position will be sustained upon examination by the appropriate taxing authorities before any part of the benefit can be recorded in the financial statements. For those tax positions where it is “not more likely than not” that a tax benefit will be sustained, no tax benefit is recognized. Penalties, if probable and reasonably estimable, are recognized as a component of income tax expense. The Company has reduced its deferred tax assets for uncertain tax positions but has not recorded liabilities for income tax expense, penalties, or interest.

Contingencies — The Company records a loss contingency for a liability when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. These accruals represent management’s best estimate of probable loss. Disclosure also is provided when it is reasonably possible that a loss will be incurred or when it is reasonably possible that the amount of a loss will exceed the recorded provision. On a quarterly basis, the Company reviews the status of each significant matter and assesses its potential financial exposure. Significant judgment is required in both the determination of probability and the determination as to whether an exposure is reasonably estimable. Because of uncertainties related to these matters, accruals are based only on the best information available at the time. As additional information becomes available, the Company reassesses the potential liability related to pending claims and litigation and may revise its estimates.

Stock-Based Compensation — Share-based payments to employees, including grants of restricted stock units (RSUs), performance-based non-qualified stock options awards (“PNQs”), restricted stock units with market conditions (“Market RSUs”), options and the compensatory elements of employee stock purchase plans, are recognized in the condensed consolidated statements of operations based upon the fair value of the awards at the grant date. RSUs are valued based on the market price on the grant date. Market RSUs are valued using a Monte Carlo valuation model and RSUs with performance conditions are evaluated for the probability that the performance conditions will be met and estimates the date at which the performance conditions will be met in order to properly recognize stock-based compensation expense over the requisite service period. The Company uses the Black-Scholes option valuation model to estimate the grant date fair value of employee stock options and the compensatory elements of employee stock purchase plans.

Clinical Trial Expenses — Clinical trial expenses, which are primarily reflected in R&D expenses in the condensed consolidated statements of operations, result from obligations under contracts with vendors, consultants and clinical site agreements in addition to internal costs associated with conducting clinical trials.

Net Income (Loss) Per Share of Common Stock — Basic net income or loss per share ("EPS") is calculated by dividing net income by the weighted average number of common shares outstanding for the period. Diluted EPS reflects the effect of potential common stock issuances resulting from assumed stock option exercises and vesting of restricted stock units, unless the effect is anti-dilutive, when applying the treasury stock method, as well as potential dilution under the if-converted method for convertible debt securities. For periods where the Company has presented a net loss, potentially dilutive securities are excluded from the computation of diluted EPS as they would be anti-dilutive.

Recently Issued Accounting StandardsFrom time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company

14


 

believes that the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s condensed consolidated financial position or results of operations upon adoption.

2. Investments

Cash Equivalents — Cash equivalents consist of highly liquid investments with original or remaining maturities of 90 days or less at the time of purchase that are readily convertible into cash.

Available-for-Sale Investment — The Thirona convertible notes are classified as available-for-sale securities and are included in prepaid expenses and other current assets in the condensed consolidated balance sheets. Available-for-sale investments are subsequently measured at fair value with realized gains and losses reported in other income (expense) in the condensed consolidated statements of operations. Unrealized holding gains and losses are excluded from earnings and reported in other comprehensive income (loss) until realized. The Company determines the fair value of its available-for-sale investments using level 3 inputs and evaluates the fair value of its investment in Thirona by applying a scenario based method. For the three months ended March 31, 2023, the Company recognized $0.1 million of interest income on investment. No interest income on investment was recognized during the three months ended March 31, 2024. The Company's investment in Thirona is comprised of two notes with aggregate face value of $8.0 million and stated interest rate of 6%. As of March 31, 2024 and December 31, 2023, the fair value of the Company's investment in Thirona was $6.9 million. No gains or losses from credit risk or unrealized holding gains or losses were recognized during the three months ended March 31, 2024 or 2023.

Held-to-Maturity Investments — Investments consist of highly liquid investments that are intended to facilitate liquidity and capital preservation. The amortization or accretion of the Company’s investments is recognized in the condensed consolidated statements of operations as interest income, which was approximately $3.4 million and $1.2 million for the three months ended March 31, 2024 and 2023, respectively. No allowance for credit losses on held-to-maturity securities was required as of March 31, 2024 or December 31, 2023.

The contractual maturities of the Company’s held-to-maturity investments are summarized below (in thousands):

 

 

March 31, 2024

 

 

December 31, 2023

 

 

 

Amortized
Cost Basis

 

 

Aggregate
Fair Value

 

 

Amortized
Cost Basis

 

 

Aggregate
Fair Value

 

Due in one year or less(1)

 

$

241,962

 

 

$

241,970

 

 

$

115,263

 

 

$

115,374

 

Due after one year through five years

 

 

3,726

 

 

 

3,771

 

 

 

7,155

 

 

 

7,197

 

Total

 

$

245,688

 

 

$

245,741

 

 

$

122,418

 

 

$

122,571

 

___________________________

(1)
The investments due in one year or less include cash equivalents of $134.5 million as of March 31, 2024 and $58.6 million as of December 31, 2023.

The fair value of the cash equivalents, long-term and short-term investments are disclosed below (dollars in thousands).

 

 

 

March 31, 2024

 

 

 

Investment Level

 

Amortized Cost
(Carrying Value)

 

 

Gross Unrealized Holding
Gains

 

 

Gross Unrealized
Holding
Losses

 

 

Estimated
Fair Value

 

Money market funds and other

 

Level 1

 

$

95,389

 

 

$

 

 

$

 

 

$

95,389

 

Commercial bonds and paper

 

Level 2

 

 

51,485

 

 

 

93

 

 

 

(71

)

 

 

51,507

 

U.S. Treasury Securities

 

Level 2

 

 

98,814

 

 

 

56

 

 

 

(25

)

 

 

98,845

 

Total cash equivalents and investments

 

 

 

 

245,688

 

 

 

149

 

 

 

(96

)

 

 

245,741

 

Less: cash equivalents

 

 

 

 

(134,505

)

 

 

 

 

 

 

 

 

(134,505

)

Total Investments

 

 

 

$

111,183

 

 

$

149

 

 

$

(96

)

 

$

111,236

 

 

15


 

 

 

December 31, 2023

 

 

 

Investment Level

 

Amortized Cost
(Carrying Value)

 

 

Gross Unrealized Holding
Gains

 

 

Gross Unrealized
Holding
Losses

 

 

Estimated
Fair Value

 

Money market funds

 

Level 1

 

$

69,611

 

 

$

 

 

$

 

 

$

69,611

 

Commercial bonds and paper

 

Level 2

 

 

43,251

 

 

 

135

 

 

 

(38

)

 

 

43,348

 

U.S. Treasury Securities

 

Level 2

 

 

9,556

 

 

 

56

 

 

 

 

 

 

9,612

 

Total cash equivalents and investments

 

 

 

 

122,418

 

 

 

191

 

 

 

(38

)

 

 

122,571

 

Less: cash equivalents

 

 

 

 

(58,644

)

 

 

 

 

 

 

 

 

(58,644

)

Total Investments

 

 

 

$

63,774

 

 

$

191

 

 

$

(38

)

 

$

63,927

 

As of March 31, 2024 and December 31, 2023, there was $0.6 million and $0.5 million, respectively, of accrued interest receivable on investments which is included in prepaid expense and other current assets in our condensed consolidated balance sheets.

3. Accounts Receivable

Accounts receivable, net consists of the following (in thousands):

 

 

March 31, 2024

 

 

December 31, 2023

 

Accounts receivable – commercial

 

 

 

 

 

 

Accounts receivable, gross

 

$

17,516

 

 

$

20,199

 

Wholesaler distribution fees and prompt pay discounts

 

 

(2,252

)

 

 

(2,469

)

Reserve for returns

 

 

(5,597

)

 

 

(6,215

)

Allowance for credit losses

 

 

(157

)

 

 

(157

)

Total accounts receivable – commercial, net

 

 

9,510

 

 

 

11,358

 

Accounts receivable &