Amneal Pharmaceuticals Inc
For the period ended Sep 30, 2024. Filed Nov 12, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Nov 12, 2024
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-09.
0001723128-24-000032
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-12.
0001723128-24-000042
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 124 previous paragraphs and 128 current paragraphs.
50 unchanged; 46 reworded; 26 added; 24 removed; 4 previous and 6 current paragraphs rearranged.
Tables are not compared: 9 previous and 9 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (26)
Current report
Net revenue for the three months ended September 30, 2024 increased 13.3% from the prior year period, primarily due to:
Current report
•Growth in our Specialty segment net revenue of $18.3 million, primarily driven by a $16.8 million increase in our promoted Parkinson’s franchise, of which $4.3 million was comprised of sales of ONGENTYS®, which launched in January 2024, and initial sales of CREXONT®, which launched in September of 2024. Additionally, growth in our promoted endocrinology portfolio of $3.8 million was partially offset by declines in our non-promoted products.
Current report
Gross profit as a percentage of net revenue increased to 38.4% for the three months ended September 30, 2024 from 37.5% in the prior year period primarily as a result of the factors noted above.
Current report
Change in Fair Value of Contingent Consideration
Current report
The $4.2 million decrease in the change in fair value of contingent consideration for the three months ended September 30, 2024 was primarily driven by a decrease in the associated forecasted revenues.
Current report
Credit related to legal matters, net was immaterial for the three months ended September 30, 2024. For the three months ended September 30, 2023, credit related to legal matters, net of $2.6 million primarily related to a $5.5 million gain from the settlement of patent infringement matters, partially offset by a $3.0 million charge for the settlement of a customer claim. Refer to Note 17. Commitments and Contingencies for additional information.
Current report
Generics net revenue for the three months ended September 30, 2024 increased 9.3% as compared to the prior year period, primarily due to new generic products launched in 2024 and 2023, which include biosimilars that contributed $5.7 million of year-over-year growth and other new generic products that contributed $34.8 million of year-over-year growth.
Current report
Generics gross profit as a percentage of net revenue increased to 41.7% for the three months ended September 30, 2024 from 39.6% in the prior year period primarily as a result of the factors noted above.
Current report
Generics SG&A expense for the three months ended September 30, 2024 decreased 7.7% as compared to the prior year period, primarily due to reduced legal fees, partially offset by increases in employee compensation.
Current report
Generics R&D expenses for the three months ended September 30, 2024 increased 62.7% as compared to the prior year period, primarily due to an increase in in-licensing and upfront milestone payments of $23.8 million, including $20.0 million associated with our exclusive license of Omalizumab (refer to Note 19. Related Party Transactions for additional information), partially offset by operating efficiencies in our infrastructure.
Current report
Credit related to legal matters, net was immaterial for the three months ended September 30, 2024. For the three months ended September 30, 2023, credit related to legal matters, net of $2.5 million primarily related to a $5.5 million gain from the settlement of patent infringement matters, partially offset by a $3.0 million charge for the settlement of a customer claim. Refer to Note 17. Commitments and Contingencies for additional information.
Current report
Specialty net revenue for the three months ended September 30, 2024 increased 18.8% compared to the prior year period, primarily driven by a $16.8 million increase in our promoted Parkinson’s franchise, of which $4.3 million was comprised of sales of ONGENTYS®, which launched in January 2024, and initial sales of CREXONT®, which launched in September of 2024. Additionally, growth in our promoted endocrinology portfolio of $3.8 million was partially offset by declines in our non-promoted products.
Current report
Change in Fair Value of Contingent Consideration
Current report
The $4.2 million decrease in the change in fair value of contingent consideration for the three months ended September 30, 2024 was primarily driven by a decrease in the associated forecasted revenues.
Current report
AvKARE net revenue for the three months ended September 30, 2024 increased 20.9% as compared to the prior year period, primarily driven bygrowth in our distribution channel and government label channel which resulted from new product introductions.
Current report
AvKARE SG&A expense for the three months ended September 30, 2024 increased 5.8% as compared to the prior year period, primarily due to increases in employee compensation.
Current report
Comparison of Nine Months Ended September 30, 2024 to Nine Months Ended September 30, 2023
Current report
Net revenue for the nine months ended September 30, 2024 increased 16.1% from the prior year period primarily due to:
Current report
Gross profit as a percentage of net revenue increased to 36.7% for the nine months ended September 30, 2024 from 35.5% in the prior year period, primarily as a result of the factors noted above.
Current report
R&D expenses for the nine months ended September 30, 2024 increased 15.8% as compared to the prior year period, primarily due to an increase in in-licensing and upfront milestone payments of $26.6 million, including $20.0 million associated with our exclusive license of Omalizumab (refer to Note 19. Related Party Transactions for additional information), partially offset by operating efficiencies in our infrastructure.
Current report
For the nine months ended September 30, 2023, credit related to legal matters, net was $1.0 million, primarily comprised of $10.0 million from the settlement of patent infringement matters, partially offset by $4.1 million in charges associated with civil prescription opioid litigation, a $3.0 million charge for the settlement of a customer claim, and a $1.9 million charge for the settlement of a stockholder derivative lawsuit.
Current report
Generics gross profit as a percentage of net revenue increased to 39.8% for the nine months ended September 30, 2024 from 37.6% in the prior year period, primarily as a result of the factors noted above.
Current report
Generics R&D expenses for the nine months ended September 30, 2024 increased 25.0% as compared to the prior year period, primarily due to an increase in in-licensing and upfront milestone payments of $26.6 million, including $20.0 million associated with our exclusive license of Omalizumab (refer to Note 19. Related Party Transactions for additional information), partially offset by operating efficiencies in our infrastructure.
Current report
For the nine months ended September 30, 2023, credit related to legal matters, net was $2.9 million, primarily comprised of $10.0 million from the settlement of patent infringement matters, partially offset by $4.1 million of charges associated with prescription opioid litigation and a $3.0 million charge for the settlement of a customer claim.
Current report
Specialty net revenue for the nine months ended September 30, 2024 increased 13.6% as compared to the prior year period, primarily driven by a $35.6 million increase in our promoted Parkinson’s franchise, of which $11.8 million was comprised of sales of ONGENTYS®, which launched in January 2024, and initial sales of CREXONT®, which launched in September 2024. Additionally, growth in our promoted endocrinology portfolio of $11.1 million was partially offset by declines in our non-promoted products.
Current report
AvKARE net revenue for the nine months ended September 30, 2024 increased 28.8% as compared to the prior year period primarily driven bygrowth in our distribution channel and government label channel which resulted from new product introductions.
Removed paragraphs (24)
Previous report
On August 7, 2024, the FDA approved the Company’s new drug application for IPX203, which will be marketed under the trade name CREXONT®. CREXONT® is a combination of carbidopa and levodopa extended-release capsules, indicated for the treatment of Parkinson’s disease. The Company expects to make CREXONT® available to patients in the U.S. in September 2024.
Previous report
Net revenue for the three months ended June 30, 2024 increased 17.1% from the prior year period primarily due to:
Previous report
Gross profit as a percentage of net revenue decreased to 35.6% for the three months ended June 30, 2024 from 36.7% in the prior year period primarily as a result of the factors noted above.
Previous report
Refer to Note 15. Fair Value Measurements for information about the estimation of our contingent consideration liabilities. The $6.4 million change in the fair value of contingent consideration for the three months ended June 30, 2023 was primarily driven by a decrease in the associated forecasted revenues.
Previous report
Generics net revenue for the three months ended June 30, 2024 increased 14.4% as compared to the prior year period primarily due to new generic products launched in 2024 and 2023, which include biosimilars that contributed $16.7 million of year-over-year growth and other new generic products that contributed $36.2 million of year-over-year growth, and strong volume growth.
Previous report
Generics gross profit as a percentage of net revenue decreased to 38.9% for the three months ended June 30, 2024 from 39.7% in the prior year period primarily as a result of the factors noted above.
Previous report
Generics R&D expenses for the three months ended June 30, 2024 increased 1.9% as compared to the prior year period primarily due to an increase in project spend of $1.0 million, partially offset by a decrease in in-licensing and upfront milestone payments.
Previous report
Specialty net revenue for the three months ended June 30, 2024 increased 7.3% compared to the prior year period, primarily driven by a $9.4 million increase in our promoted neurology portfolio, of which $3.5 million was comprised of sales of ONGENTYS®, which launched during the first quarter of 2024, and growth in our promoted endocrinology portfolio of $2.7 million, partially offset by declines in our non-promoted products.
Previous report
Refer to Note 15. Fair Value Measurements for information about the estimation of our contingent consideration liabilities. The $6.4 million change in the fair value of contingent consideration for the three months ended June 30, 2023 was primarily driven by a decrease in the associated forecasted revenues.
Previous report
AvKARE net revenue for the three months ended June 30, 2024 increased 32.8% as compared to the prior year period primarily driven bygrowth in our distribution channel and government label channel which resulted from new product introductions.
Previous report
Comparison of Six Months Ended June 30, 2024 to Six Months Ended June 30, 2023
Previous report
Net revenue for the six months ended June 30, 2024 increased 17.7% from the prior year period primarily due to:
Previous report
•Growth in our Specialty segment net revenue of $20.6 million, primarily driven by an $18.8 million increase in our promoted neurology portfolio, of which $7.5 million was comprised of sales of ONGENTYS®, which launched during the first quarter of 2024, and growth in our promoted endocrinology portfolio of $7.3 million, partially offset by declines in our non-promoted products.
Previous report
Gross profit as a percentage of net revenue increased to 35.9% for the six months ended June 30, 2024 from 34.4% in the prior year period primarily as a result of the factors noted above.
Previous report
R&D expenses for the six months ended June 30, 2024 decreased 1.5% as compared to the prior year period primarily due to lower project spend of $1.4 million and operating efficiencies in our infrastructure, partially offset by an increase in in-licensing and upfront milestone payments of $2.8 million.
Previous report
Refer to Note 15. Fair Value Measurements for information about the estimation of our contingent consideration liabilities. The $3.9 million change in the fair value of contingent consideration for the six months ended June 30, 2023 was primarily driven by a decrease in the associated forecasted revenues.
Previous report
Provision For Income Taxes
Previous report
Generics gross profit as a percentage of net revenue increased to 38.8% for the six months ended June 30, 2024 from 36.5% in the prior year period primarily as a result of the factors noted above.
Previous report
Generics R&D expenses for the six months ended June 30, 2024 increased 4.1% as compared to the prior year period primarily due to an increase in in-licensing and upfront milestone payments of $2.8 million.
Previous report
Specialty net revenue for the six months ended June 30, 2024 increased 10.9% as compared to the prior year period, primarily driven by an $18.8 million increase in our promoted neurology portfolio, of which $7.5 million was comprised of sales of ONGENTYS®, which launched during the first quarter of 2024, and growth in our promoted endocrinology portfolio of $7.3 million, partially offset by declines in our non-promoted products.
Previous report
Refer to Note 15. Fair Value Measurements for information about the estimation of our contingent consideration liabilities. The $3.9 million change in the fair value of contingent consideration for the six months ended June 30, 2023 was primarily driven by a decrease in the associated forecasted revenues.
Previous report
AvKARE net revenue for the six months ended June 30, 2024 increased 33.0% as compared to the prior year period primarily driven bygrowth in our distribution channel and government label channel which resulted from new product introductions.
Previous report
Omalizumab Exclusive License and Commercialization Agreement
Previous report
Subsequent to June 30, 2024, we paid Kashiv Biosciences LLC (“Kashiv”), a related party, $20.0 million in connection with an exclusive license and commercialization agreement for Amneal to distribute and sell Omalizumab, a biosimilar to XOLAIR®, in the U.S. and India. Refer to Note 21. Subsequent Events for additional information.
Reworded paragraphs (46)
Previous wording
The following discussion and analysis for the three and six months ended June 30, 2024 should also be read in conjunction with the consolidated financial statements and related notes thereto included elsewhere in this Quarterly Report on Form 10-Q and with our audited consolidated financial statements for the year ended December 31, 2023 included in our 2023 Annual Report on Form 10-K.
Current wording
The following discussion and analysis for the three and nine months ended September 30, 2024 should also be read in conjunction with the consolidated financial statements and related notes thereto included elsewhere in this Quarterly Report on Form 10-Q and with our audited consolidated financial statements for the year ended December 31, 2023 included in our 2023 Annual Report on Form 10-K.
Previous wording
Our Specialty segment is engaged in the development, promotion, sale and distribution of proprietary branded pharmaceutical products, with a focus on products addressing central nervous system (“CNS”) disorders, including Parkinson’s disease, and endocrine disorders. Our portfolio of products includes RYTARY®, an extended release oral capsule formulation of carbidopa-levodopa for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. In addition to RYTARY®, our promoted Specialty portfolio also includes UNITHROID® (levothyroxine sodium), for the treatment of hypothyroidism, which is sold under a license and distribution agreement with Jerome Stevens Pharmaceuticals, Inc., and ONGENTYS® (opicapone), an add-on treatment to carbidopa/levodopa in patients with Parkinson’s disease experiencing “Off” episodes, which we commenced selling in early 2024 under a license agreement with BIAL-Portela & Ca., S.A.
Current wording
Our Specialty segment is engaged in the development, promotion, sale and distribution of proprietary branded pharmaceutical products, with a focus on products addressing central nervous system disorders, including Parkinson’s disease, and endocrine disorders. Our portfolio of products includes RYTARY® (extended release oral capsule formulation of carbidopa-levodopa), CREXONT® (combination of carbidopa and levodopa extended release capsules), UNITHROID® (levothyroxine sodium), and ONGENTYS® (opicapone). RYTARY® is indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. On August 7, 2024, the FDA approved our new drug application for CREXONT®, previously referred to as IPX203. We began selling CREXONT®, which is indicated for the treatment of Parkinson’s disease, in September 2024. UNITHROID®, indicated for the treatment of hypothyroidism, is sold under a license and distribution agreement with Jerome Stevens Pharmaceuticals, Inc. ONGENTYS® is an add-on treatment to carbidopa/levodopa in patients with Parkinson’s disease experiencing “Off” episodes, which we commenced selling in early 2024 under a license agreement with BIAL-Portela & Ca., S.A.
Previous wording
While it is difficult to accurately measure the impact of inflation, we estimate our business will experience an increase in costs due to inflation of approximately $10.0 million to $15.0 million for the year ending December 31, 2024, excluding the impact of rising interest rates. Notwithstanding our estimates, rising inflationary pressures due to higher input costs, including higher material, transportation, labor and other costs, could exceed our expectations, which would further adversely impact our operating results in future periods.
Current wording
While it is difficult to accurately measure the impact of inflation, we estimate our business will experience an increase in costs due to inflation of approximately $10.0 million to $15.0 million for the year ending December 31, 2024, excluding the impact of interest rates. Notwithstanding our estimates, rising inflationary pressures due to higher input costs, including higher material, transportation, labor and other costs, could exceed our expectations, which would further adversely impact our operating results in future periods.
Previous wording
•Growth in our Generics segment net revenue of $53.6 million, primarily due to new generic products launched in 2024 and 2023, which include biosimilars that contributed $16.7 million of year-over-year growth and other new generic products that contributed $36.2 million of year-over-year growth, and strong volume growth.
Current wording
•Growth in our Generics segment net revenue of $36.5 million, primarily due to new generic products launched in 2024 and 2023, which include biosimilars that contributed $5.7 million of year-over-year growth and other new generic products that contributed $34.8 million of year-over-year growth.
Previous wording
•Growth in our AvKARE segment net revenue of $42.1 million, primarily driven bygrowth in our distribution channel and government label channel which resulted from new product introductions.
Current wording
•Growth in our AvKARE segment net revenue of $27.6 million, primarily driven bygrowth in our distribution channel and government label channel which resulted from new product introductions.
Previous wording
Cost of goods sold increased 19.2% for thethree months ended June 30, 2024 as compared to the prior year period. The increase in cost of goods sold was primarily due to increased AvKARE and Generics volume and increased plant and freight costs, partially offset by efficiencies in our supply costs.
Current wording
Cost of goods sold increased 11.7% for thethree months ended September 30, 2024 as compared to the prior year period. The increase in cost of goods sold was primarily due to increased AvKARE and Generics volume, increased plant and freight costs, and an increased inventory provision, partially offset by efficiencies in our supply costs.
Previous wording
Selling, general, and administrative (“SG&A”) expenses for the three months ended June 30, 2024 increased 10.3% as compared to the prior year period primarily due to increases in employee compensation, promotion associated with ONGENTYS® and our planned launch of IPX203, and costs associated with growth in biosimilar revenues.
Current wording
Selling, general, and administrative (“SG&A”) expenses for the three months ended September 30, 2024 increased 5.0% as compared to the prior year period, primarily due to increases in employee compensation and promotion associated with ONGENTYS® and CREXONT®.
Previous wording
Research and development (“R&D”) expenses for the three months ended June 30, 2024 decreased 4.6% as compared to the prior year period primarily due to a decrease in in-licensing and upfront milestone payments of $0.7 million and operating efficiencies in our infrastructure.
Current wording
Research and development (“R&D”) expenses for the three months ended September 30, 2024 increased 47.7% as compared to the prior year period, primarily due to an increase in in-licensing and upfront milestone payments of $23.8 million, including $20.0 million associated with our exclusive license of Omalizumab (refer to Note 19. Related Party Transactions for additional information), partially offset by operating efficiencies in our infrastructure.
Previous wording
Total other expense, net for the six months ended June 30, 2024 increased 48.3% as compared to the prior year period. The increase was primarily driven by a $31.3 million increase in interest expense as a result of higher rates on our variable-rate debt and an increase in the amount outstanding on our revolving credit facility and a $14.2 million increase in our tax receivable agreement liability (refer to Note 5. Income Taxes for additional information), partially offset by a gain on the sale of a subsidiary in India of $3.8 million (refer to Note 19. Related Party Transactions for additional information).
Current wording
Total other expense, net for the three months ended September 30, 2024 increased 39.3% as compared to the prior year period. The increase was primarily driven by a $14.6 million increase in interest expense as a result of higher rates on our variable-rate debt and an increase in the amount outstanding on our revolving credit facility and a $10.7 million increase in our tax receivable agreement liability (refer to Note 5. Income Taxes for additional information), partially offset by a gain resulting from favorable period-over-period foreign exchange rates primarily driven by the Euro.
Previous wording
For the three months ended June 30, 2024, our provision for income taxes and effective tax rate were $3.6 million and 17.7%, respectively. For the three months ended June 30, 2023, the Company’s benefit from income taxes and effective tax rate were both immaterial. The period-over-period changes in the provision for income taxes and effective tax rate were primarily related to changes in the jurisdictional mix of income.
Current wording
For the three months ended September 30, 2024, our provision for income taxes and effective tax rate were $3.7 million and 23.8%, respectively. For the three months ended September 30, 2023, the Company’s benefit from income taxes and effective tax rate were$(2.1) million and (9.0)%, respectively. The period-over-period changes in the provision for income taxes and effective tax rate were primarily related to changes in the jurisdictional mix of income and a discrete Indian tax benefit of approximately $2.9 million from the utilization of a loss carryforward during the three months ended September 30, 2023.
Previous wording
Generics cost of goods sold for the three months ended June 30, 2024 increased 15.9% as compared to the prior year period primarily due to costs associated with increased sales volume and increased plant and freight costs, partially offset by efficiencies in our supply costs.
Current wording
Generics cost of goods sold for the three months ended September 30, 2024 increased 5.5% as compared to the prior year period, primarily due to costs associated with increased sales volume and increased plant and freight costs, partially offset by efficiencies in our supply costs.
Previous wording
Specialty cost of goods sold for the three months ended June 30, 2024 was flat compared to the prior year period, as growth in promoted products was offset by declines in our lower margin non-promoted products. Specialty gross profit as a percentage of net revenue increased to 55.7% for the three months ended June 30, 2024 as compared to 52.0% in the prior year period due to growth in our higher margin promoted products.
Current wording
Specialty gross profit as a percentage of net revenue increased to 54.7% for the three months ended September 30, 2024 as compared to 53.2% in the prior year period, primarily due to growth in our higher margin promoted products.
Previous wording
Specialty SG&A expense for the three months ended June 30, 2024 increased 16.9% as compared to the prior year period primarily due to increases in promotional costs associated with ONGENTYS® and our planned launch of IPX203.
Current wording
Specialty SG&A expense for the three months ended September 30, 2024 increased 21.8% as compared to the prior year period, primarily due to increases in promotional costs associated with ONGENTYS® and CREXONT®.
Previous wording
Specialty R&D expenses for the three months ended June 30, 2024 decreased 35.0% as compared to the prior year period primarily due to reduced project spend of $1.1 million and reduced infrastructure costs.
Current wording
Specialty R&D expense for the three months ended September 30, 2024 decreased 36.3% as compared to the prior year period, primarily due to reduced project spend of $0.7 million and reduced infrastructure costs.
Previous wording
AvKARE cost of goods sold for the three months ended June 30, 2024 increased 34.9% as compared to the prior year period, and gross profit as a percentage of net revenue decreased to 15.0% for the three months ended June 30, 2024 from 16.4% in the prior year period, primarily due to the increase in sales through our lower margin distribution channel.
Current wording
AvKARE cost of goods sold for the three months ended September 30, 2024 increased 24.2% as compared to the prior year period, and gross profit as a percentage of net revenue decreased to 17.7% for the three months ended September 30, 2024 from 19.9% in the prior year period, primarily due to the increase in sales through our lower margin distribution channel and an increased inventory provision.
Previous wording
The following table sets forth our summarized, consolidated results of operations for the six months ended June 30, 2024 and 2023 (in thousands):
Current wording
The following table sets forth our summarized, consolidated results of operations for the nine months ended September 30, 2024 and 2023 (in thousands):
Previous wording
•Growth in our Generics segment net revenue of $101.1 million, primarily due to new generic products launched in 2024 and 2023, which include biosimilars that contributed $41.3 million of year-over-year growth and other new generic products that contributed $55.4 million of year-over-year growth, and strong volume growth. Net revenue for thesix months ended June 30, 2023 included a non-recurring customer order of $21.0 million.
Current wording
•Growth in our Generics segment net revenue of $137.6 million, primarily due to new generic products launched in 2024 and 2023, which include biosimilars that contributed $47.0 million of year-over-year growth and other new generic products that contributed $90.2 million of year-over-year growth, and strong volume growth, partially offset by price erosion. Net revenue for thenine months ended September 30, 2023 included a non-recurring customer order of $21.0 million.
Previous wording
•Growth in our AvKARE segment net revenue of $82.7 million, primarily driven bygrowth in our distribution channel and government label channel which resulted from new product introductions.
Current wording
•Growth in our AvKARE segment net revenue of $110.3 million, primarily driven bygrowth in our distribution channel and government label channel which resulted from new product introductions.
Previous wording
•Growth in our Specialty segment net revenue of $7.0 million, primarily driven by a $9.4 million increase in our promoted neurology portfolio, of which $3.5 million was comprised of sales of ONGENTYS®, which launched during the first quarter of 2024, and growth in our promoted endocrinology portfolio of $2.7 million, partially offset by declines in our non-promoted products.
Current wording
•Growth in our Specialty segment net revenue of $38.9 million, primarily driven by a $35.6 million increase in our promoted Parkinson’s franchise, of which $11.8 million was comprised of sales of ONGENTYS®, which launched in January 2024, and initial sales of CREXONT®, which launched in September 2024. Additionally, growth in our promoted endocrinology portfolio of $11.1 million was partially offset by declines in our non-promoted products.
Previous wording
Cost of goods sold increased 15.1% for the six months ended June 30, 2024 as compared to the prior year period. The increase in cost of goods sold was primarily due to increased AvKARE and Generics volume and increased plant and freight costs, partially offset by efficiencies in our supply costs. Cost of goods sold for the six months ended June 30, 2023 included $11.0 million associated with the non-recurring customer order in our Generics segment discussed above.
Current wording
Cost of goods sold increased 14.0% for the nine months ended September 30, 2024 as compared to the prior year period. The increase in cost of goods sold was primarily due to increased AvKARE and Generics volume, increased plant and freight costs, and an increased inventory provision, partially offset by efficiencies in our supply costs. Cost of goods sold for the nine months ended September 30, 2023 included $11.0 million associated with the non-recurring customer order in our Generics segment discussed above.
Previous wording
SG&A expenses for the six months ended June 30, 2024 increased 10.3% as compared to the prior year period primarily due to increases in employee compensation, promotion associated with ONGENTYS® and our planned launch of IPX203, charges associated with our growing biosimilars, and annual fees assessed on branded prescription drug manufacturers, which are also applicable to certain of our generic products.
Current wording
SG&A expenses for the nine months ended September 30, 2024 increased 8.4% as compared to the prior year period, primarily due to increases in employee compensation, promotion associated with ONGENTYS® and CREXONT®, increased charges associated with our growing biosimilars, and annual fees assessed on branded prescription drug manufacturers, which are also applicable to certain of our generic products.
Previous wording
For the six months ended June 30, 2024, charges related to legal matters, net of $95.1 million were primarily associated with a settlement in principle on the primary financial terms for a nationwide resolution to the opioids cases that have been filed and that might have been filed against the Company by political subdivisions and Native American tribes across the U.S. Refer to Note 17. Commitments and Contingencies for additional information.
Current wording
For the nine months ended September 30, 2024, charges related to legal matters, net of $94.9 million were primarily associated with a settlement in principle on the primary financial terms for a nationwide resolution to the opioids cases that have been filed and that might have been filed against us by political subdivisions and Native American tribes across the U.S. Refer to Note 17. Commitments and Contingencies for additional information.
Previous wording
Total other expense, net for the three months ended June 30, 2024 increased 48.9% as compared to the prior year period. The increase was primarily driven by a $14.9 million increase in interest expense as a result of higher rates on our variable-rate debt and an increase in the amount outstanding on our revolving credit facility and a $13.0 million increase in our tax receivable agreement liability (refer to Note 5. Income Taxes for additional information), partially offset by a gain on the sale of a subsidiary in India of $3.8 million (refer to Note 19. Related Party Transactions for additional information).
Current wording
Total other expense, net for the nine months ended September 30, 2024 increased 45.1% as compared to the prior year period. The increase was primarily driven by a $45.9 million increase in interest expense as a result of higher rates on our variable-rate debt and an increase in the amount outstanding on our revolving credit facility and a $24.8 million increase in our tax receivable agreement liability (refer to Note 5. Income Taxes for additional information), partially offset by a gain on the sale of a subsidiary in India of $3.8 million (refer to Note 19. Related Party Transactions for additional information).
Previous wording
For the six months ended June 30, 2024, our provision for income taxes and effective tax rate were$9.8 million and(17.7)%, respectively, as compared to a provision for income taxes and effective tax rate of$0.6 million and 3.2%, respectively, for the six months ended June 30, 2023. The period-over-period changes in the provision for income taxes and effective tax rate primarily related to changes in the jurisdictional mix of income.
Current wording
For the nine months ended September 30, 2024, our provision for income taxes and effective tax rate were$13.4 million and(33.9)%, respectively, as compared to a benefit from income taxes and effective tax rate of$(1.4) million and(3.3)%, respectively, for the nine months ended September 30, 2023. The period-over-period changes in the provision for income taxes and effective tax rate primarily related to changes in the jurisdictional mix of income and a discrete Indian tax benefit of approximately $2.9 million from the utilization of a loss carryforward during the three months ended September 30, 2023.
Previous wording
The following table sets forth results of operations for our Generics segment for the six months ended June 30, 2024 and 2023 (in thousands):
Current wording
The following table sets forth results of operations for our Generics segment for the nine months ended September 30, 2024 and 2023 (in thousands):
Previous wording
Generics net revenue for the six months ended June 30, 2024 increased 14.1% as compared to the prior year period primarily due to new generic products launched in 2024 and 2023, which include biosimilars that contributed $41.3 million of year-over-year growth and other new generic products that contributed $55.4 million of year-over-year growth, and strong volume growth. Net revenue for thesix months ended June 30, 2023 included a non-recurring customer order of $21.0 million.
Current wording
Generics net revenue for the nine months ended September 30, 2024 increased 12.4% as compared to the prior year period, primarily due to new generic products launched in 2024 and 2023, which include biosimilars that contributed $47.0 million of year-over-year growth and other new generic products that contributed $90.2 million of year-over-year growth, and strong volume growth, partially offset by price erosion. Net revenue for thenine months ended September 30, 2023 included a non-recurring customer order of $21.0 million.
Previous wording
Generics cost of goods sold for the six months ended June 30, 2024 increased 9.9% as compared to the prior year period primarily due to costs associated with increased sales volume and increased plant and freight costs, partially offset by efficiencies in our supply costs. Cost of goods sold for thesix months ended June 30, 2023 included $11.0 million associated with the non-recurring customer order discussed above.
Current wording
Generics cost of goods sold for the nine months ended September 30, 2024 increased 8.4% as compared to the prior year period, primarily due to costs associated with increased sales volume and increased plant and freight costs, partially offset by efficiencies in our supply costs. Cost of goods sold for thenine months ended September 30, 2023 included $11.0 million associated with the non-recurring customer order discussed above.
Previous wording
Generics SG&A expense for the six months ended June 30, 2024 increased 16.3% as compared to the prior year period primarily due to increases in employee compensation driven by infrastructure expansion and promotion associated with our biosimilar launches and the annual fees assessed on branded prescription drug manufacturers.
Current wording
Generics SG&A expense for the nine months ended September 30, 2024 increased 7.3% as compared to the prior year period, primarily due to increases in employee compensation driven by infrastructure expansion and promotion associated with our biosimilar launches and the annual fees assessed on branded prescription drug manufacturers (applicable to certain of our generic products), partially offset by reduced legal fees.
Previous wording
For the six months ended June 30, 2024, charges related to legal matters, net of $95.1 million were primarily associated with a settlement in principle on the primary financial terms for a nationwide resolution to the opioids cases that have been filed and that might have been filed against the Company by political subdivisions and Native American tribes across the U.S. Refer to Note 17. Commitments and Contingencies for additional information.
Current wording
For the nine months ended September 30, 2024, charges related to legal matters, net of $94.9 million were primarily associated with a settlement in principle on the primary financial terms for a nationwide resolution to the opioids cases that have been filed and that might have been filed against us by political subdivisions and Native American tribes across the U.S. Refer to Note 17. Commitments and Contingencies for additional information.
Previous wording
The following table sets forth results of operations for our Specialty segment for the six months ended June 30, 2024 and 2023 (in thousands):
Current wording
The following table sets forth results of operations for our Specialty segment for the nine months ended September 30, 2024 and 2023 (in thousands):
Previous wording
Specialty cost of goods sold for the six months ended June 30, 2024 increased 1.4% as compared to the prior year period, primarily due to growth in our promoted products, partially offset by declines in our lower margin non-promoted products. Specialty gross profit as a percentage of net revenue increased to 56.5% for the six months ended June 30, 2024 as compared to 52.5% in the prior year period due to growth in our higher margin promoted products.
Current wording
Specialty cost of goods sold for the nine months ended September 30, 2024 increased 5.9% as compared to the prior year period, primarily due to growth in our promoted products, partially offset by declines in our lower margin non-promoted products. Specialty gross profit as a percentage of net revenue increased to 55.9% for the nine months ended September 30, 2024 as compared to 52.7% in the prior year period due to growth in our higher margin promoted products.
Previous wording
Specialty SG&A expense for the six months ended June 30, 2024 increased 14.8% as compared to the prior year period primarily due to increases in promotional costs associated with ONGENTYS® and our planned launch of IPX203 and an increase in the annual fees assessed on branded prescription drug manufacturers.
Current wording
Specialty SG&A expense for the nine months ended September 30, 2024 increased 17.1% as compared to the prior year period, primarily due to increases in promotional costs associated with ONGENTYS® and CREXONT®.
Previous wording
Specialty R&D expenses for the six months ended June 30, 2024 decreased 28.8% as compared to the prior year period primarily due to reduced project spend of $1.7 million and reduced infrastructure costs.
Current wording
Specialty R&D expenses for the nine months ended September 30, 2024 decreased 31.2% as compared to the prior year period, primarily due to reduced project spend of $2.4 million and reduced infrastructure costs.
Previous wording
The following table sets forth results of operations for our AvKARE segment for the six months ended June 30, 2024 and 2023 (in thousands):
Current wording
The following table sets forth results of operations for our AvKARE segment for the nine months ended September 30, 2024 and 2023 (in thousands):
Previous wording
AvKARE cost of goods sold for the six months ended June 30, 2024 increased 32.1% as compared to the prior year period, and gross profit as a percentage of net revenue increased to 15.6% for the six months ended June 30, 2024 from 15.0% in the prior year period, primarily due to the increase in sales through our higher margin government channel, including higher margin new product introductions.
Current wording
AvKARE cost of goods sold for the nine months ended September 30, 2024 increased 29.4% as compared to the prior year period, and gross profit as a percentage of net revenue decreased to 16.3% for the nine months ended September 30, 2024 from 16.7% in the prior year period, primarily due to the increase in sales through our lower margin distribution channel and an increased inventory provision.
Previous wording
AvKARE SG&A expense for the three months ended June 30, 2024 increased 4.5% as compared to the prior year period primarily due to higher sales-related expenses and professional fees, partially offset by reduced logistic costs.
Current wording
AvKARE SG&A expense for the nine months ended September 30, 2024 increased 8.3% as compared to the prior year period, primarily due to higher sales-related expenses, increases in employee compensation and higher professional fees, partially offset by reduced logistic costs.
Previous wording
Our primary source of liquidity is cash generated from operations, available cash on hand, and borrowings under debt financing arrangements (as defined and discussed in Note 16. Debt in our 2023 Annual Report on Form 10-K). We have access to$416.9 million of available capacity under the Amended New Revolving Credit Facility and$28.0 million of available capacity under the Amended Rondo Revolving Credit Facility as of June 30, 2024. We believe these sources are sufficient to fund our planned operations, meet our interest and contractual obligations, including acquisitions, and provide sufficient liquidity over the next 12 months from the date of filing of this Form 10-Q. However, our ability to satisfy our working capital requirements and debt obligations will depend upon economic conditions, our ability to negotiate and maintain satisfactory terms under our borrowing and debt facilities in the future, and demand for our products, which are factors that may be out of our control. Our primary uses of capital resources are to fund operating activities, including R&D expenses associated with new product filings, and pharmaceutical product manufacturing expenses, license payments, spending on production facility expansions, capital equipment, acquisitions, and legal settlements.
Current wording
Our primary source of liquidity is cash generated from operations, available cash on hand, and borrowings under debt financing arrangements (as defined and discussed in Note 16. Debt in our 2023 Annual Report on Form 10-K). We have access to$455.2 million of available capacity under the Amended New Revolving Credit Facility and$28.0 million of available capacity under the Amended Rondo Revolving Credit Facility as of September 30, 2024. We believe these sources are sufficient to fund our planned operations, meet our interest and contractual obligations, including acquisitions, and provide sufficient liquidity over the next 12 months from the date of filing of this Form 10-Q. However, our ability to satisfy our working capital requirements and debt obligations will depend upon economic conditions, our ability to negotiate and maintain satisfactory terms under our borrowing and debt facilities in the future, and demand for our products, which are factors that may be out of our control. Our primary uses of capital resources are to fund operating activities, including R&D expenses associated with new product filings, and pharmaceutical product manufacturing expenses, license payments, spending on production facility expansions, capital equipment, acquisitions, and legal settlements.
Previous wording
We estimate that we will invest approximately $60.0 million to $70.0 million during 2024 for capital expenditures to support and grow our existing operations, primarily related to investments in manufacturing equipment, information technology and facilities.
Current wording
We estimate that we will invest approximately $60.0 million to $70.0 million during 2024 for capital expenditures to support and grow our existing operations, primarily related to investments in manufacturing facilities and equipment, and information technology.
Previous wording
Over the next 12 months, we expect to make substantial payments, including monthly interest and quarterly principal amounts due for our Term Loan Due 2028, monthly interest and the remaining principal balance on our Term Loan Due 2025, monthly interest on our Amended New Credit Facility, and contractual payments for leased premises. Refer to Note 16. Debt, Note 18. Leases, and Commitments and Contractual Obligations under Part II, Item 7. Management’s Discussion and Analysis of
Current wording
Over the next 12 months, we expect to make substantial payments, including monthly interest and quarterly principal amounts due for our Term Loan Due 2028, monthly interest and the remaining principal balance on our Term Loan Due 2025, monthly interest on our Amended New Credit Facility, and contractual payments for leased premises. Refer to Note 16. Debt, Note 18. Leases, and Commitments and Contractual Obligations under Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations in our 2023 Annual Report on Form 10-K for additional information on our indebtedness and leases, respectively.
Previous wording
In late April 2024, we reached a nationwide settlement in principle on the primary financial terms, with no admission of wrongdoing, for a nationwide resolution to the opioids cases that have been filed and that might have been filed by Attorneys General, political subdivisions and Native American tribes. Refer to Note 17. Commitments and Contingencies for additional information.
Current wording
In late April 2024, we reached a nationwide settlement in principle on the primary financial terms, with no admission of wrongdoing, for a nationwide resolution to the opioids cases that have been filed and that might have been filed by Attorneys
Showing the first 40 of 46 pairs. Open the source sections for the rest.
Rearranged current paragraphs (6)
Current report — wording carried from elsewhere
Credit Related to Legal Matters, Net
Current report — wording carried from elsewhere
Credit Related to Legal Matters, Net
Current report — wording carried from elsewhere
Specialty cost of goods sold for the three months ended September 30, 2024 increased 14.9% compared to the prior year period, primarily due to increased sales volume in our promoted products, partially offset by declines in our lower margin non-promoted products.
Current report — wording carried from elsewhere
Provision For (Benefit From) Income Taxes
Current report — wording carried from elsewhere
Charges (Credit) Related to Legal Matters, Net
Current report — wording carried from elsewhere
General, political subdivisions and Native American tribes. Refer to Note 17. Commitments and Contingencies for additional information.
Rearranged previous paragraphs (4)
Previous report — wording carried elsewhere
Generics SG&A expense for the three months ended June 30, 2024 increased 12.8% as compared to the prior year period primarily due to increases in employee compensation driven by infrastructure expansion and promotion associated with our biosimilars.
Previous report — wording carried elsewhere
Charges Related to Legal Matters, Net
Previous report — wording carried elsewhere
AvKARE SG&A expense for the six months ended June 30, 2024 increased 9.6% as compared to the prior year period primarily due to higher sales-related expenses, partially offset by reduced logistic costs.
Previous report — wording carried elsewhere
Financial Condition and Results of Operations in our 2023 Annual Report on Form 10-K for additional information on our indebtedness and leases, respectively. Also refer to Note 21. Subsequent Events in this Form 10-Q.