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Assertio Reports Second Quarter 2024 Financial Results

Globe Newswire 7-Aug-2024 4:01 PM

Second Quarter Total Net Product Sales of $30.7 Million

Rolvedon Growth Continues, with $15.1 million in Net Product Sales

$7.4 Million in Cash Flow from Operations, Cash and Short-Term Investments Increases to $88.4 Million

LAKE FOREST, Ill., Aug. 07, 2024 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. ("Assertio" or the "Company") (NASDAQ:ASRT), a pharmaceutical company with comprehensive commercial capabilities offering differentiated products to patients, today reported financial results for the second quarter ended June 30, 2024.

"In my first two months at Assertio, I have been excited to work closely with the team, meet our growing list of oncology clinic customers and focus on how best to maximize our results going forward. The second quarter's performance illustrates how we continue to diligently execute the three pillars of Assertio's business plan: driving the financial performance of Assertio's key assets, including our lead asset Rolvedon, generating cash flow and identifying new assets to create further value for our stockholders," said Brendan O'Grady, who was appointed Chief Executive Officer on May 29, 2024.

"Rolvedon has been well received by physicians and continues to increase its share of the oncology G-CSF market, generating its sixth consecutive quarter of demand growth since launch. As a potential opportunity for further differentiation, we have also completed enrollment of Rolvedon's same-day dosing trial and expect to present the initial data at a medical conference later this year. Combined with the rest of our platform and pipeline of prospective business development opportunities, I am excited about the potential for Assertio." 

Financial Highlights (unaudited):

 Three Months Ended  Six Months Ended
(in millions, except per share amounts)June 30,
2024
 March 31,
2024
 June 30,
2023
 June 30,
2024
 June 30,
2023
Net Product Sales (GAAP)$30.7  $31.9  $40.1 $62.6  $81.9
Net (Loss) Income (GAAP)$(3.7) $(4.5) $8.5 $(8.2) $5.0
(Loss) Income Per Share (GAAP)$(0.04) $(0.05) $0.13 $(0.09) $0.09
Adjusted EBITDA (Non-GAAP)1$5.0  $7.4  $24.8 $12.4  $50.4
Adjusted Earnings Per Share (Non-GAAP)1$0.02  $0.04  $0.19 $0.06  $0.48
                  

Second quarter results included the following highlights (our discussion below focuses on a comparison of second quarter 2024 to first quarter 2024 given the acquisition of Spectrum and the generic competition of Indocin introduced in the third quarter 2023):

  • Rolvedon net product sales increased to $15.1 million in the second quarter from $14.5 million in the first quarter, driven by continued volume growth, partially offset by lower net pricing.
  • Indocin net product sales in the second quarter were $6.9 million, decreased from $8.7 million in the first quarter, due to the previously announced generic competition affecting both volume and pricing.
  • Gross margin2 in the second quarter was 71% compared to 65% in the first quarter. Excluding Rolvedon purchase accounting inventory step-up amortization, gross margin decreased to 73% in the second quarter from 78% in the first quarter, primarily due to an increase in inventory write downs in late life-cycle stage products and a change in product mix.
  • SG&A expense in the second quarter was $18.4 million, slightly decreased from $18.5 million in the first quarter. Second quarter SG&A expense benefited from a $1.9 million gain on the settlement of insurance reimbursement claims, which was offset by higher legal and general operating expenses.
  • Adjusted EBITDA3 was $5.0 million in the second quarter, decreased from $7.4 million in the first quarter, primarily due to the impact of lower net product sales and an increase in inventory write down expense. 

Balance Sheet and Cash Flow

  • Assertio generated approximately $7.4 million in cash flow from operations in the second quarter, compared to approximately $7.5 million in the first quarter.
  • For the quarter ended June 30, 2024, cash, cash equivalents and short-term investments increased to $88.4 million from $80.7 million at March 31, 2024.
  • Debt at June 30, 2024 was $40.0 million, comprised of the Company's 6.5% convertible notes, with no maturities until September 2027.

2024 Full Year Financial Guidance

Assertio reiterated its 2024 operating guidance as announced on March 11, 2024:

Net Product Sales (GAAP)$110.0 Million to $125.0 Million
Adjusted EBITDA (Non-GAAP)3$20.0 Million to $30.0 Million
  

Conference Call and Investor Presentation Information

Assertio's management will host a conference call to discuss its second quarter 2024 financial results today:

Date:Wednesday, August 7, 2024
Time:4:30 p.m. Eastern Time
Webcast (live and archive):http://investor.assertiotx.com/overview/default.aspx
(Events & Webcasts, Investor Page)
Dial-in numbers:1-646-307-1963, Conference ID 4674653
  

To access the live webcast, the recorded conference call replay, and other materials, please visit Assertio's investor relations website at http://investor.assertiotx.com/overview/default.aspx. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. The replay will be available approximately two hours after the call on Assertio's investor website.

1 Non-GAAP measures are reconciled to the corresponding GAAP measures in the schedules attached.
2 Gross margin represents the ratio of net product sales less cost of sales to net product sales.
3 See "Non-GAAP Financial Measures" below for information about reconciling our Adjusted EBITDA guidance to Net (Loss) Income.

About Assertio

Assertio is a commercial pharmaceutical company with comprehensive commercial capabilities offering differentiated products to patients. We have built our commercial portfolio through acquisition or licensing of approved products. Our commercial capabilities include marketing through both a sales force and a non-personal promotion model, market access through payor contracting, and trade and distribution. To learn more about Assertio, visit www.assertiotx.com.

Investor Contact

Matt Kreps, Managing Director
Darrow Associates
M: 214-597-8200
mkreps@darrowir.com

Forward Looking Statements

The statements in this communication include forward-looking statements. Forward-looking statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs. Forward-looking statements speak only as of the date they are made or as of the dates indicated in the statements and should not be relied upon as predictions of future events, as there can be no assurance that the events or circumstances reflected in these statements will be achieved or will occur. Forward-looking statements can often, but not always, be identified by the use of forward-looking terminology including such as "anticipate," "approximate", "believe," "could," "estimate," "expect," "goal," "intend," "may," "might," "opportunity," "plan," "potential," "project," "prospective," "pursue," "seek," "should," "strategy," "target," "will," or the negative of these words and phrases, other variations of these words and phrases or comparable terminology. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the statements, including: Assertio's ability to grow sales of Rolvedon and the commercial success and market acceptance of Rolvedon and Assertio's other products; Assertio's ability to successfully develop and execute its sales, marketing and promotion strategies using its sales force and non-personal promotion model capabilities; the impact on sales and profits from the entry and sales of generics of Assertio's products and/or other products competitive with any of Assertio's products (including indomethacin suppositories compounded by hospitals and other institutions including a 503B compounder which we believe to be violation of certain provisions of the Food, Drug and Cosmetic Act); the timing and impact of additional generic approvals and uncertainty around the recent approvals and launches of generic Indocin products (which are not patent protected and now face generic competition as a result of the August 2023 approval and launch of generic indomethacin suppositories and January 2024 approval and subsequent launch of a generic indomethacin oral suspension product); risks that any new businesses will not be integrated successfully or that the combined company will not realize estimated cost savings, value of certain tax assets, synergies and growth, or that such benefits may take longer and/or cost more to realize than expected; expected industry trends, including pricing pressures and managed healthcare practices; Assertio's ability to attract and retain executive leadership and key employees; the ability of Assertio's third-party manufacturers to manufacture adequate quantities of commercially salable inventory and active pharmaceutical ingredients for each of Assertio's products on commercially reasonable terms and in compliance with their contractual obligations to Assertio, and Assertio's ability to maintain its supply chain which relies on single-source suppliers; the outcome of, and Assertio's intentions with respect to, any litigation or government investigations, including pending and potential future shareholder litigation relating to the Spectrum Merger and/or the recent approval and launch of generic indomethacin suppositories, antitrust litigation, opioid-related government investigations and opioid-related litigation, the recently unsealed qui tam litigation, as well as Spectrum's legacy shareholder and other litigation and, and other disputes and litigation, and the costs and expenses associated therewith; Assertio's financial cost and outcomes of clinical trials, including the extent to which data from the Rolvedon same-day dosing trial may support ongoing commercialization efforts; Assertio's compliance with legal and regulatory requirements related to the development or promotion of its products; variations in revenues obtained from commercialization agreements and the accounting treatment with respect thereto; Assertio's common stock maintaining compliance with The Nasdaq Capital Market's minimum closing bid requirement of at least $1.00 per share, particularly in light of Assertio's stock trading below or only slight above $1.00 per share recently; and Assertio's ability to obtain and maintain intellectual property protection for its products and operate its business without infringing the intellectual property rights of others. For a discussion of additional factors that could cause actual results to differ materially from those contemplated by forward-looking statements, see the risks described in Assertio's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Many of these risks and uncertainties may be exacerbated by public health emergencies and general macroeconomic conditions. Assertio does not assume, and hereby disclaims, any obligation to update forward-looking statements, except as may be required by law.

Non-GAAP Financial Measures

To supplement the Company's financial results presented on a U.S. generally accepted accounting principles ("GAAP") basis, the Company has included information about non-GAAP measures of EBITDA, adjusted EBITDA, adjusted earnings, and adjusted earnings per share as useful operating metrics. The Company believes that the presentation of these non-GAAP financial measures, when viewed with results under GAAP and the accompanying reconciliation, provides supplementary information to analysts, investors, lenders, and the Company's management in assessing the Company's performance and results from period to period. The Company uses these non-GAAP measures internally to understand, manage and evaluate the Company's performance, and in part, in the determination of bonuses for executive officers and employees. These non-GAAP financial measures should be considered in addition to, and not a substitute for, or superior to, net income or other financial measures calculated in accordance with GAAP. Non-GAAP financial measures used by us may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies.

This release also includes estimated full-year non-GAAP adjusted EBITDA information, which the Company believes enables investors to better understand the anticipated performance of the business, but should be considered a supplement to, and not as a substitute for or superior to, financial measures calculated in accordance with GAAP. No reconciliation of estimated non-GAAP adjusted EBITDA to estimated net income is provided in this release because some of the information necessary for estimated net income such as income taxes, fair value change in contingent consideration, and stock-based compensation is not yet ascertainable or accessible and the Company is unable to quantify these amounts that would be required to be included in estimated net income without unreasonable efforts.

Specified Items

Non-GAAP measures presented within this release exclude specified items. The Company considers specified items to be significant income/expense items not indicative of current operations. Specified items may include adjustments to interest expense and interest income, income tax expense (benefit), depreciation expense, amortization expense, sales reserves adjustments for products the Company is no longer selling, stock-based compensation expense, fair value adjustments to contingent consideration or derivative liability, restructuring charges, amortization of fair value inventory step-up as a result of purchase accounting, transaction-related costs, gains, losses or impairments from adjustments to long-lived assets and assets not part of current operations, changes in valuation allowances on deferred tax assets, and gains or losses resulting from debt refinancing or extinguishment.


CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS) INCOME
(in thousands, except per share amounts)
(unaudited)

 Three Months Ended  Six Months Ended June 30,
 June 30, 2024 March 31, 2024 June 30, 2023 June 30, 2024 June 30, 2023
Revenues:         
Product sales, net$30,695  $31,862  $40,083  $62,557  $81,852 
Royalties and milestones 431   586   723   1,017   1,420 
Other revenue       185      185 
Total revenues 31,126   32,448   40,991   63,574   83,457 
Costs and expenses:         
Cost of sales 8,889   11,177   4,772   20,066   10,239 
Research and development expenses 798   733   503   1,531   503 
Selling, general and administrative expenses 18,385   18,524   16,771   36,909   33,675 
Change in fair value of contingent consideration       241      9,408 
Amortization of intangible assets 6,671   5,631   6,284   12,302   12,568 
Restructuring charges    720      720    
Total costs and expenses 34,743   36,785   28,571   71,528   66,393 
(Loss) income from operations (3,617)  (4,337)  12,420   (7,954)  17,064 
Other income (expense):         
Debt-related expenses             (9,918)
Interest expense (758)  (757)  (751)  (1,515)  (1,873)
Interest income 842   712   650   1,554   1,109 
Other gain 8   4   11   12   354 
Total other income (expense) 92   (41)  (90)  51   (10,328)
Net (loss) income before income taxes (3,525)  (4,378)  12,330   (7,903)  6,736 
Income tax expense (149)  (132)  (3,860)  (281)  (1,750)
Net (loss) income$(3,674) $(4,510) $8,470  $(8,184) $4,986 
          
Basic net (loss) income per share$(0.04) $(0.05) $0.15  $(0.09) $0.09 
Diluted net (loss) income per share$(0.04) $(0.05) $0.13  $(0.09) $0.09 
Shares used in computing basic net (loss) income per share 95,240   94,980   56,142   95,110   53,588 
Shares used in computing diluted net (loss) income per share 95,240   94,980   70,144   95,110   58,010 
                    

 CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)

 (Unaudited)  
 June 30, 2024 December 31, 2023
ASSETS   
Current assets:   
Cash and cash equivalents$44,735  $73,441 
Short-term investments 43,644    
Accounts receivable, net 39,913   47,663 
Inventories, net 39,080   37,686 
Prepaid and other current assets 10,480   12,272 
Total current assets 177,852   171,062 
Property and equipment, net 664   770 
Intangible assets, net 99,030   111,332 
Other long-term assets 1,897   3,255 
Total assets$279,443  $286,419 
LIABILITIES AND SHAREHOLDERS' EQUITY   
Current liabilities:   
Accounts payable$15,271  $13,439 
Accrued rebates, returns and discounts 58,424   58,137 
Accrued liabilities 15,124   18,213 
Contingent consideration, current portion 2,700   2,700 
Other current liabilities 665   954 
Total current liabilities 92,184   93,443 
Long-term debt 38,729   38,514 
Other long-term liabilities 16,377   16,459 
Total liabilities 147,290   148,416 
Commitments and contingencies   
Shareholders' equity:   
Common stock, $0.0001 par value, 200,000,000 shares authorized; 95,333,214 and 94,668,523 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively. 9   9 
Additional paid-in capital 791,871   789,537 
Accumulated deficit (659,727)  (651,543)
Total shareholders' equity 132,153   138,003 
Total liabilities and shareholders' equity$279,443  $286,419 
 

 CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)

 Six Months Ended June 30,
 2024 2023
Operating Activities   
Net (loss) income$(8,184) $4,986 
Adjustments to reconcile net (loss) income to net cash from operating activities:   
Depreciation and amortization 12,407   12,964 
Amortization of debt issuance costs and Royalty Rights 215   248 
Accretion of interest income from short-term investments (338)   
Recurring fair value measurements of assets and liabilities 15   9,408 
Debt-related expenses    9,918 
Provisions for inventory and other assets 3,877   1,390 
Stock-based compensation 2,615   4,651 
Deferred income taxes    (1,385)
Changes in assets and liabilities:   
Accounts receivable 7,750   3,749 
Inventories (5,271)  (6,511)
Prepaid and other assets 3,150   4,289 
Accounts payable and other accrued liabilities (1,627)  4,906 
Accrued rebates, returns and discounts 286   (6,569)
Interest payable    (726)
Net cash provided by operating activities 14,895   41,318 
Investing Activities   
Purchases of property and equipment    (528)
Purchase of Sympazan    (280)
Purchases of short-term investments (43,320)   
Net cash used in investing activities (43,320)  (808)
Financing Activities   
Payments in connection with 2027 Convertible Notes    (10,500)
Payment of direct transaction costs related to convertible debt inducement    (1,119)
Payment of contingent consideration    (15,408)
Payment of Royalty Rights    (459)
Proceeds from exercise of stock options    157 
Payments related to the vesting and settlement of equity awards, net (281)  (7,947)
Net cash used in financing activities (281)  (35,276)
Net (decrease) increase in cash and cash equivalents (28,706)  5,234 
Cash and cash equivalents at beginning of year 73,441   64,941 
Cash and cash equivalents at end of period$44,735  $70,175 
Supplemental Disclosure of Cash Flow Information   
Net cash paid for income taxes$1,384  $2,295 
Cash paid for interest$1,300  $2,351 
        

RECONCILIATION OF GAAP NET (LOSS) INCOME TO NON-GAAP EBITDA and ADJUSTED EBITDA
(in thousands)
(unaudited)

 Three Months Ended Six Months Ended  
 June 30,
2024
 March 31,
2024
 June 30,
2023
 June 30,
2024
 June 30,
2023
 Financial Statement
Classification
GAAP Net (Loss) Income$(3,674) $(4,510) $8,470  $(8,184) $4,986   
Interest expense 758   757   751   1,515   1,873  Interest expense
Income tax expense 149   132   3,860   281   1,750  Income tax expense
Depreciation expense 40   65   195   105   396  Selling, general and administrative expenses
Amortization of intangible assets 6,671   5,631   6,284   12,302   12,568  Amortization of intangible assets
EBITDA (Non-GAAP)$3,944  $2,075  $19,560  $6,019  $21,573   
Adjustments:           
Legacy product reserves       (185)     (185) Other revenue
Stock-based compensation 1,408   1,207   2,205   2,615   4,651  Selling, general and administrative expenses
Change in fair value of contingent consideration (1)       241      9,408  Change in fair value of contingent consideration
Debt-related expenses (2)             9,918  Debt-related expenses
Transaction-related expenses (3)       3,448      5,803  Selling, general and administrative expenses
Restructuring costs(4)    720      720     Restructuring charges
Other (5) (366)  3,377   (495)  3,010   (790) Multiple
Adjusted EBITDA (Non-GAAP)$4,986  $7,379  $24,774  $12,364  $50,378   


(1)The fair value of the contingent consideration is remeasured each reporting period, with changes in the fair value resulting from changes in the underlying inputs being recognized as a benefit or expense in operating expenses until the contingent consideration arrangement is settled.
(2)Debt-related expenses consist of an induced conversion expense of approximately $8.8 million and direct transaction costs of approximately $1.1 million incurred as a result of the privately negotiated exchange of $30.0 million principal amount of the Company's 6.5% Convertible Senior Notes due 2027 in the first quarter of 2023.
(3)Represents transaction-related expenses associated with the acquisition of Spectrum, which closed effective July 31, 2023.
(4)Restructuring costs represent non-recurring costs associated with the Company's announced restructuring plans.
(5)Other for the three and six months ended June 30, 2024 and 2023, and the three months ended March 31, 2024, represents the following adjustments (in thousands):


  Three Months Ended Six Months Ended  
  June 30, 2024 March 31, 2024 June 30, 2023 June 30, 2024 June 30, 2023 Financial Statement
Classification
Amortization of inventory step-up $476  $4,089  $155  $4,564  $319  Cost of sales
Interest income  (842)  (712)  (650)  (1,554)  (1,109) Interest income
Total Other $(366) $3,377  $(495) $3,010  $(790)  
 

RECONCILIATION OF GAAP NET (LOSS) INCOME and NET (LOSS) INCOME PER SHARE TO
NON-GAAP ADJUSTED EARNINGS and ADJUSTED EARNINGS PER SHARE (1)
(in thousands, except per share amounts)
(unaudited)

 Three Months Ended
 June 30, 2024 March 31, 2024 June 30, 2023
 Amount Diluted
EPS(2)
 Amount Diluted
EPS(2)
 Amount Diluted
EPS(2)
Net (loss) income (GAAP)(2)$(3,674) $(0.04) $(4,510) $(0.05) $8,470  $0.13
Add: Convertible debt interest expense and other income statement impacts, net of tax(2)           563   
Adjustments:           
Amortization of intangible assets$6,671    $5,631     6,284   
Legacy products revenue reserves           (185)  
Stock-based compensation 1,408     1,207     2,205   
Change in fair value of contingent consideration           241   
Contingent consideration cash payable (3)           (5,615)  
Transaction-related expenses           3,448   
Restructuring costs      720        
Other (366)    3,377     (495)  
Income tax benefit expense, as adjusted (4) (1,928)    (2,734)    (1,471)  
Adjusted earnings (Non-GAAP)$2,111  $0.02  $3,691  $0.04  $13,445  $0.19
            
Diluted shares used in calculation (GAAP)(2) 95,240     94,980     70,144   
Add: Dilutive effect of stock-based awards and equivalents(2) 394     271        
Add: Dilutive effect of 2027 Convertible Notes(2)              
Diluted shares used in calculation (Non-GAAP)(2) 95,634     95,251     70,144   


(1)Certain adjustments included here are the same as those reflected in the Company's reconciliation of GAAP net (loss) income to non-GAAP adjusted EBITDA and therefore should be read in conjunction with that reconciliation and respective footnotes.
  
(2)The Company uses the if-converted method with respect to its convertible debt to compute GAAP and Non-GAAP diluted earnings per share when the effect is dilutive. Under the if-converted method, the Company assumes the 2027 Convertible Notes were converted at the beginning of each period presented and outstanding. As a result, interest expense, net of tax, and any other income statement impact associated with the 2027 Convertible Notes, net of tax, is added back to net income used in the diluted earnings per share calculation.
  
 For both the three months ended June 30, 2024 and March 31, 2024, the Company's potentially dilutive convertible debt under the if-converted method and stock-based awards under the treasury-stock method were not included in the computation of GAAP net loss and diluted net loss per share, and the potentially dilutive convertible debt under the if-converted method were not included in non-GAAP adjusted earnings and adjusted earnings per share, because to do so would be anti-dilutive. However, the potentially dilutive stock-based awards under the treasury-stock method were included in the computation of non-GAAP adjusted earnings and adjusted earnings per share because the effect was dilutive.
  
 For the three months ended June 30, 2023, the Company's potentially dilutive convertible debt under the if-converted method and stock-based awards under the treasury-stock method were included in the computation of GAAP net income and diluted net income per share, and non-GAAP adjusted earnings and adjusted earnings per share because the effect was dilutive.
  
(3)Represents the accrued cash payable, if any, of the INDOCIN contingent consideration for the respective period based on 20% royalty for annual INDOCIN net sales over $20.0 million.  
  
(4)Represents the Company's income tax expense adjustment from the tax effect of pre-tax adjustments excluded from adjusted earnings. The tax effect of pre-tax adjustments excluded from adjusted earnings is computed at the blended federal and state statutory rate of 25%.
  

RECONCILIATION OF GAAP NET (LOSS) INCOME and NET (LOSS) INCOME PER SHARE TO
NON-GAAP ADJUSTED EARNINGS and ADJUSTED EARNINGS PER SHARE (1)
(in thousands, except per share amounts)
(unaudited)

 Six Months Ended
 June 30, 2024 June 30, 2023
 Amount Diluted EPS (2) Amount Diluted EPS (2)
Net loss (GAAP)(2)$(8,184) $(0.09) $4,986  $0.09
Add: Convertible debt interest expense and other income statement impacts, net of tax(2)      1,405   
Adjustments:       
Amortization of intangible assets 12,302     12,568   
Legacy products revenue reserves      (185)  
Stock-based compensation 2,615     4,651   
Debt-related expenses, net      9,639   
Change in fair value of contingent consideration      9,408   
Contingent consideration cash payable(3)      (7,684)  
Transaction-related expenses      5,803   
Restructuring costs 720        
Other 3,010     (790)  
Income tax benefit expense, as adjusted(4) (4,662)    (5,943)  
Adjusted earnings (Non-GAAP) 5,801  $0.06   33,858  $0.48
        
Diluted shares used in calculation (GAAP)(2) 95,110     58,010   
Add: Dilutive effect of stock-based awards and equivalents(2) 307        
Add: Dilutive effect of 2027 Convertible Notes(2)      12,116   
Diluted shares used in calculation (Non-GAAP)(2) 95,417     70,126   


(1)Certain adjustments included here are the same as those reflected in the Company's reconciliation of GAAP net (loss) income to non-GAAP adjusted EBITDA and therefore should be read in conjunction with that reconciliation and respective footnotes.
  
(2)The Company uses the if-converted method with respect to its convertible debt to compute GAAP and Non-GAAP diluted earnings per share when the effect is dilutive. Under the if-converted method, the Company assumes the 2027 Convertible Notes were converted at the beginning of each period presented and outstanding. As a result, interest expense, net of tax, and any other income statement impact associated with the 2027 Convertible Notes, net of tax, is added back to net income used in the diluted earnings per share calculation.
  
 For the six months ended June 30, 2024, the Company's potentially dilutive convertible debt under the if-converted method and stock-based awards under the treasury-stock method were not included in the computation of GAAP net loss and diluted net loss per share, and the potentially dilutive convertible debt under the if-converted method were not included in non-GAAP adjusted earnings and adjusted earnings per share, because to do so would be anti-dilutive. However, the potentially dilutive stock-based awards under the treasury-stock method were included in the computation of non-GAAP adjusted earnings and adjusted earnings per share because the effect was dilutive.
  
 For the six months ended June 30, 2023, the Company's potentially dilutive convertible debt under the if-converted method was not included in the computation of GAAP net income and diluted net income per share, because to do so would be anti-dilutive. However, the Company's potentially dilutive convertible debt under the if-converted method was included in the computation of non-GAAP adjusted earnings and adjusted earnings per share as its effect was dilutive. The potentially dilutive stock-based awards under the treasury-stock method were included in the computation of GAAP net income and net income per share and non-GAAP adjusted earnings and adjusted earnings per share because the effect was dilutive.
  
(3)Represents the accrued cash payable, if any, of the INDOCIN contingent consideration for the respective period based on 20% royalty for annual INDOCIN net sales over $20.0 million.
  
(4)Represents the Company's income tax expense adjustment from the tax effect of pre-tax adjustments excluded from adjusted earnings. The tax effect of pre-tax adjustments excluded from adjusted earnings is computed at the blended federal and state statutory rate of 25%.
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