Amphastar Pharmaceuticals, Inc.: Amphastar Pharmaceuticals Reports Financial Results for the Three Months Ended June 30, 2024

Reports Net Revenues of $182.4 Million for the Three Months Ended June 30, 2024

RANCHO CUCAMONGA, CA / ACCESSWIRE / August 7, 2024 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) ("Amphastar" or the "Company") today reported results for the three months ended June 30, 2024.

Second Quarter Highlights

• Net revenues of $182.4 million for the second quarter

• GAAP net income of $37.9 million, or $0.73 per share, for the second quarter

• Adjusted non-GAAP net income of $48.7 million, or $0.94 per share, for the second quarter

Dr. Jack Zhang, Amphastar's President and Chief Executive Officer, commented: "As we finish another strong quarter, Amphastar has continued its impressive performance with solid sales growth. BAQSIMI^® has emerged as a leading driver in our portfolio. This commercial success underscores our strategic commitment to high-value areas, particularly as we continue the transition of our pipeline towards branded products and biosimilars."

		Three Months Ended								Six Months Ended
		June 30,								June 30,
		2024				2023				2024				2023
		(in thousands, except per share data)
Net revenues		$	182,394			$	145,712			$	354,230			$	285,734
GAAP net income		$	37,949			$	26,124			$	81,126			$	52,156
Adjusted non-GAAP net income*		$	48,688			$	34,782			$	103,984			$	66,925
GAAP diluted EPS		$	0.73			$	0.49			$	1.54			$	0.99
Adjusted non-GAAP diluted EPS*		$	0.94			$	0.65			$	1.98			$	1.27

____________________________________

* Adjusted non-GAAP net income and adjusted non-GAAP diluted EPS are non-GAAP financial measures. Please see the discussion in the section entitled "Non-GAAP Financial Measures" and the reconciliation of GAAP to non-GAAP financial measures in Table III of this press release.

Second Quarter Results

		Three Months Ended
		June 30,								Change
		2024				2023				Dollars				%
		(in thousands)
Product revenues:
BAQSIMI®		$	30,854			$	-			$	30,854				N/A
Epinephrine			27,941				16,714				11,227				67	%
Glucagon			27,373				27,276				97				0	%
Primatene MIST®			22,856				16,520				6,336				38	%
Lidocaine			12,800				14,006				(1,206	)			(9	)%
Phytonadione			10,304				17,855				(7,551	)			(42	)%
Enoxaparin			5,273				7,872				(2,599	)			(33	)%
Naloxone			3,800				5,102				(1,302	)			(26	)%
Other finished pharmaceutical products			34,652				37,521				(2,869	)			(8	)%
Total finished pharmaceutical products net revenues		$	175,853			$	142,866			$	32,987				23	%
API			3,535				2,846				689				24	%
Other revenues			3,006				-				3,006				N/A
Total net revenues		$	182,394			$	145,712			$	36,682				25	%

Changes in product revenues as compared to the second quarter of the prior year were primarily driven by:

• BAQSIMI^® sales consisting of $30.9 million in sales made by the Company directly to its customers, which are recorded as part of Product Revenues, net, and $7.6 million in sales made by Eli Lilly & Company on behalf of the Company under a Transition Services Agreement, which resulted in a net payment to the Company of $3.0 million after deducting cost of sales and other expenses and was recorded in Other Revenues

• Epinephrine sales increased primarily due to an increase in unit volumes as a result of an increase in demand caused by other supplier shortages

• Primatene MIST^® sales increased primarily due to an increase in unit volumes

• Lidocaine and phytonadione sales decreased primarily due to a decrease in unit volumes as a result of other suppliers returning to their historical distribution levels

• Enoxaparin and naloxone sales decreased primarily due to a decrease in unit volumes

• Other finished pharmaceutical product sales changes were primarily due to:

  • During the quarter, we did not have any sales of MPA, as our Active Pharmaceutical Ingredient ("API") supplier discontinued making the active ingredient, a $4.6 million impact

  • Lower unit sales of atropine, as a result of other suppliers returning to their historical distribution levels

  • These decreases were partially offset by higher unit volumes of dextrose and sodium bicarbonate due to an increase in demand caused by other supplier shortages during the quarter

• API sales increased primarily due to the timing of customer purchases

		Three Months Ended
		June 30,								Change
		2024				2023				Dollars				%
		(in thousands)
Net revenues		$	182,394			$	145,712			$	36,682				25	%
Cost of revenues			87,228				72,974				14,254				20	%
Gross profit		$	95,166			$	72,738			$	22,428				31	%
as % of net revenues			52.2	%			49.9	%

Changes in the cost of revenues and gross margin were primarily driven by:

• Increased sales of higher-margin products such as BAQSIMI^®, Primatene MIST^®, and epinephrine

• This was partially offset by:

  • Increase in depreciation and amortization expense related to the acquired BAQSIMI^® assets

  • Increases in labor costs and certain component costs

		Three Months Ended
		June 30,								Change
		2024				2023				Dollars				%
		(in thousands)
Selling, distribution, and marketing		$	9,012			$	6,718			$	2,294				34	%
General and administrative			13,285				12,281				1,004				8	%
Research and development			17,652				16,843				809				5	%

• Selling, distribution, and marketing expenses increased primarily due to the expansion of our sales and marketing efforts related to BAQSIMI^®

• General and administrative expenses increased primarily due to an increase in salary and personnel-related expenses and expenses related to BAQSIMI^®

• Research and development expenses increased due to an increase in salary and personnel-related expenses, which was partially offset by a decrease in clinical trial expenses due to the timing of clinical trials

		Three Months Ended
		June 30,								Change
		2024				2023				Dollars				%
						(in thousands)
Non-operating income (expenses)
Interest income		$	3,337			$	1,030			$	2,307			NM
Interest expense			(8,609	)			(3,602	)			(5,007	)		NM
Other income (expenses), net			298				(1,516	)			1,814			NM
Total non-operating income (expenses), net		$	(4,974	)		$	(4,088	)		$	(886	)		22	%

The change in non-operating income (expenses), net is primarily a result of:

• An increase in interest income resulting from an increase in cash and investments

• An increase in interest expense resulting from the term loan used to finance the acquisition of BAQSIMI^®, as well as the 2029 Convertible Notes

• A change to other income (expenses), net primarily as a result of foreign currency fluctuation, as well as mark-to-market adjustments relating to our interest rate swap contracts

Cash flow provided by operating activities for the six months ended June 30, 2024 was $124.4 million.

Pipeline Information

The Company currently has three abbreviated new drug applications ("ANDAs") on file with the U.S. Food and Drug Administration (the "FDA") targeting products with a market size of over $3 billion, three biosimilar products in development targeting products with a market size of over $7 billion, and four generic products in development targeting products with a market size of over $3 billion. This market information is based on IQVIA data for the 12 months ended June 30, 2024. The Company is developing multiple proprietary products with injectable and intranasal dosage forms.

Amphastar's Chinese subsidiary, Amphastar Nanjing Pharmaceuticals, Co., Ltd. ("ANP"), currently has multiple Drug Master Files ("DMFs"), on file with the FDA and is developing several additional DMFs.

Company Information

Amphastar is a bio-pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation, and intranasal products. Additionally, the Company sells insulin API products. Most of the Company's finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. More information and resources are available at www.amphastar.com.

Amphastar's logo and other trademarks or service marks of Amphastar, including, but not limited to Amphastar^®, BAQSIMI^®, Primatene MIST^®, REXTOVY^TM, Amphadase^®, and Cortrosyn^®, are the property of Amphastar.

Non-GAAP Financial Measures

To supplement its consolidated financial statements, which are prepared and presented in accordance with U.S. generally accepted accounting principles ("GAAP"), the Company is disclosing non-GAAP financial measures when providing financial results. The Company believes that an evaluation of its ongoing operations (and comparisons of its current operations with historical and future operations) would be difficult if the disclosure of its financial results were limited to financial measures prepared only in accordance with GAAP. As a result, the Company is disclosing certain non-GAAP results, including (i) Adjusted non-GAAP net income (loss) and (ii) Adjusted non-GAAP diluted EPS, which exclude amortization expense, share-based compensation, impairment charges, expenses related to our acquisition of BAQSIMI®, certain debt issuance costs, legal settlements, and other one-time events in order to supplement investors' and other readers' understanding and assessment of the Company's financial performance because the Company's management uses these measures internally for forecasting, budgeting, and measuring its operating performance. Whenever the Company uses such non-GAAP measures, it will provide a reconciliation of non-GAAP financial measures to their most directly comparable GAAP financial measures. Investors and other readers are encouraged to review the related GAAP financial measures and the reconciliation of non-GAAP measures to their most directly comparable GAAP measures set forth below and should consider non-GAAP measures only as a supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with GAAP.

Conference Call Information

The Company will hold a conference call to discuss its financial results today, August 7, 2024, at 2:00 p.m. Pacific Time.

To access the conference call, dial toll-free [phone] or [phone] for international callers, ten minutes before the conference.

The call can also be accessed on the Investors page on the Company's website at www.amphastar.com.

Forward-Looking Statements

All statements in this press release and in the conference call referenced above that are not historical are forward-looking statements, including, among other things, statements relating to our expectations regarding future financial performance and business trends, our future growth, sales and marketing of our products, market size and expansion, product portfolio, product development, the timing of FDA filings or approvals, including the DMFs of ANP, the timing of product launches, acquisitions and other matters related to our pipeline of product candidates, the timing and results of clinical trials, the prospective benefits of the acquisition of BAQSIMI^®, including its potential for continued revenue growth, the success of our integration of BAQSIMI^®, the transition of our pipeline towards branded products and biosimilars, and other future events. These statements are not facts but rather are based on Amphastar's historical performance and our current expectations, estimates, and projections regarding our business, operations, and other similar or related factors. Words such as "may," "might," "will," "could," "would," "should," "anticipate," "predict," "potential," "continue," "expect," "intend," "plan," "project," "believe," "estimate," and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Amphastar's control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Amphastar's filings with the Securities and Exchange Commission, including in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on February 29, 2024 and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, filed with the SEC on May 10, 2024. In particular, there can be no guarantee that the acquisition of BAQSIMI^® will be beneficial to our business in the long term, that any event, change or other circumstance could cause the results of the acquisition and integration of BAQSIMI^® into our product portfolio to differ from Amphastar's expectation, that all or any of the contingent consideration will be payable on the terms described herein or at all, or that Amphastar can reliably predict the impact of BAQSIMI^® on its financial results or financial guidance. You can locate these reports through our website at http://ir.amphastar.com and on the SEC's website at www.sec.gov. The forward-looking statements in this release speak only as of the date of the release. Amphastar undertakes no obligation to revise or update information or any forward-looking statements in this press release or the conference call referenced above to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause our expectations to change.

Contact Information:

Amphastar Pharmaceuticals, Inc.
Bill Peters
Chief Financial Officer
[phone]

Table I
Amphastar Pharmaceuticals, Inc.
Condensed Consolidated Statement of Operations
(Unaudited; in thousands, except per share data)

		Three Months Ended								Six Months Ended
		June 30,								June 30,
		2024				2023				2024				2023
Net revenues:
Product revenues, net		$	179,388			$	145,712			$	337,017			$	285,734
Other revenues			3,006				-				17,213				-
Total net revenues			182,394				145,712				354,230				285,734
Cost of revenues			87,228				72,974				168,964				139,156
Gross profit			95,166				72,738				185,266				146,578
Operating expenses:
Selling, distribution, and marketing			9,012				6,718				18,383				13,827
General and administrative			13,285				12,281				28,961				25,764
Research and development			17,652				16,843				34,695				36,658
Total operating expenses			39,949				35,842				82,039				76,249
Income from operations			55,217				36,896				103,227				70,329
Non-operating income (expenses):
Interest income			3,337				1,030				5,893				1,954
Interest expense			(8,609	)			(3,602	)			(17,220	)			(4,000	)
Other income (expenses), net			298				(1,516	)			6,219				(1,906	)
Total non-operating income (expenses), net			(4,974	)			(4,088	)			(5,108	)			(3,952	)
Income before income taxes			50,243				32,808				98,119				66,377
Income tax provision			12,294				6,383				16,420				13,135
Net income before equity in losses of unconsolidated affiliate			37,949				26,425				81,699				53,242
Equity in losses of unconsolidated affiliate			-				(301	)			(573	)			(1,086	)
Net income		$	37,949			$	26,124			$	81,126			$	52,156
Net income per share:
Basic		$	0.77			$	0.54			$	1.67			$	1.08
Diluted		$	0.73			$	0.49			$	1.54			$	0.99
Weighted-average shares used to compute net income per share:
Basic			48,907				48,404				48,560				48,202
Diluted			52,046				53,102				52,530				52,536

Table II
Amphastar Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(Unaudited; in thousands, except share data)

		June 30,				December 31,
		2024				2023
		(unaudited)
ASSETS
Current assets:
Cash and cash equivalents		$	189,619			$	144,296
Restricted cash			235				235
Short-term investments			28,156				112,510
Restricted short-term investments			2,200				2,200
Accounts receivable, net			131,412				114,943
Inventories			122,411				105,833
Income tax refunds and deposits			667				526
Prepaid expenses and other assets			7,945				9,057
Total current assets			482,645				489,600
Property, plant, and equipment, net			287,999				282,746
Finance lease right-of-use assets			469				564
Operating lease right-of-use assets			32,104				32,333
Investment in unconsolidated affiliate			-				527
Goodwill and intangible assets, net			600,849				613,295
Long-term investments			9,944				14,685
Other assets			24,260				25,910
Deferred tax assets			53,252				53,252
Total assets		$	1,491,522			$	1,512,912
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued liabilities		$	131,212			$	93,366
Accrued payments for BAQSIMI®			-				126,090
Income taxes payable			1,514				1,609
Current portion of long-term debt			249				436
Current portion of operating lease liabilities			3,996				3,906
Total current liabilities			136,971				225,407
Long-term reserve for income tax liabilities			6,066				6,066
Long-term debt, net of current portion and unamortized debt issuance costs			586,853				589,579
Long-term operating lease liabilities, net of current portion			29,483				29,721
Other long-term liabilities			18,803				22,718
Total liabilities			778,176				873,491
Commitments and contingencies
Stockholders' equity:
Preferred stock: par value $0.0001; 20,000,000 shares authorized; no shares issued and outstanding			-				-
Common stock: par value $0.0001; 300,000,000 shares authorized; 60,482,455 and 48,962,414 shares issued and outstanding, respectively, as of June 30, 2024 and 59,390,194 and 48,068,881 shares issued and outstanding, respectively, as of December 31, 2023			6				6
Additional paid-in capital			487,571				486,056
Retained earnings			490,394				409,268
Accumulated other comprehensive loss			(8,826	)			(8,478	)
Treasury stock			(255,799	)			(247,431	)
Total equity			713,346				639,421
Total liabilities and stockholders' equity		$	1,491,522			$	1,512,912

Table III
Amphastar Pharmaceuticals, Inc.
Reconciliation of Non-GAAP Measures
(Unaudited; in thousands, except per share data)

		Three Months Ended								Six Months Ended
		June 30,								June 30,
		2024				2023				2024				2023
GAAP net income		$	37,949			$	26,124			$	81,126			$	52,156
Adjusted for:
Intangible asset amortization			6,193				242				12,360				483
Share-based compensation			5,780				4,865				13,140				10,976
Impairment of long-lived assets			-				2,700				-				2,700
Expenses related to BAQSIMI® acquisition			1,825				3,307				3,651				4,524
Income tax provision on pre-tax adjustments			(3,059	)			(2,456	)			(6,293	)			(3,914	)
Adjusted non-GAAP net income		$	48,688			$	34,782			$	103,984			$	66,925
Adjusted non-GAAP net income per share:
Basic		$	0.99			$	0.72			$	2.14			$	1.39
Diluted		$	0.94			$	0.65			$	1.98			$	1.27
Weighted-average shares used to compute adjusted non-GAAP net income per share:
Basic			48,907				48,404				48,560				48,202
Diluted			52,046				53,102				52,530				52,536

		Three Months Ended June 30, 2024
						Selling,				General				Research				Non-operating
		Cost of				distribution				and				and				(expenses)				Income
		revenue				and marketing				administrative				development				income, net				tax provision
GAAP		$	87,228			$	9,012			$	13,285			$	17,652			$	(4,974	)		$	12,294
Intangible asset amortization			(6,173	)			-				-				(20	)			-				-
Share-based compensation			(1,325	)			(268	)			(3,653	)			(534	)			-				-
Expenses related to BAQSIMI® acquisition			-				-				-				-				1,825				-
Income tax provision on pre-tax adjustments			-				-				-				-				-				3,059
Non-GAAP		$	79,730			$	8,744			$	9,632			$	17,098			$	(3,149	)		$	15,353

		Three Months Ended June 30, 2023
						Selling,				General				Research				Non-operating
		Cost of				distribution				and				and				(expenses)				Income
		revenue				and marketing				administrative				development				income, net				tax provision
GAAP		$	72,974			$	6,718			$	12,281			$	16,843			$	(4,088	)		$	6,383
Intangible asset amortization			(222	)			-				(20	)			-				-				-
Share-based compensation			(1,158	)			(227	)			(2,991	)			(489	)			-				-
Impairment of long-lived assets			(2,700	)			-				-				-				-				-
Expenses related to BAQSIMI® acquisition			-				-				(283	)			-				3,024				-
Income tax provision on pre-tax adjustments			-				-				-				-				-				2,456
Non-GAAP		$	68,894			$	6,491			$	8,987			$	16,354			$	(1,064	)		$	8,839

		Six Months Ended June 30, 2024
						Selling,				General				Research				Non-operating
		Cost of				distribution				and				and				(expenses)				Income
		revenue				and marketing				administrative				development				income, net				tax provision
GAAP		$	168,964			$	18,383			$	28,961			$	34,695			$	(5,108	)		$	16,420
Intangible asset amortization			(12,320	)			-				(3	)			(37	)			-				-
Share-based compensation			(3,450	)			(528	)			(7,529	)			(1,633	)			-				-
Expenses related to BAQSIMI® acquisition			-				-				-				-				3,651				-
Income tax provision on pre-tax adjustments			-				-				-				-				-				6,293
Non-GAAP		$	153,194			$	17,855			$	21,429			$	33,025			$	(1,457	)		$	22,713

		Six Months Ended June 30, 2023
						Selling,				General				Research				Non-operating
		Cost of				distribution				and				and				(expenses)				Income
		revenue				and marketing				administrative				development				income, net				tax provision
GAAP		$	139,156			$	13,827			$	25,764			$	36,658			$	(3,952	)		$	13,135
Intangible asset amortization			(433	)			-				(50	)			-				-				-
Share-based compensation			(2,864	)			(436	)			(6,348	)			(1,328	)			-				-
Impairment of long-lived assets			(2,700	)			-				-				-				-				-
Expenses related to BAQSIMI® acquisition			-				-				(1,500	)			-				3,024				-
Income tax provision on pre-tax adjustments			-				-				-				-				-				3,914
Non-GAAP		$	133,159			$	13,391			$	17,866			$	35,330			$	(928	)		$	17,049

SOURCE: Amphastar Pharmaceuticals, Inc.

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