Amphastar Pharmaceuticals Reports Financial Results for the Three Months and Full-Year Ended December 31, 2021

Rhea-AI Summary

Amphastar Pharmaceuticals (NASDAQ:AMPH) reported net revenues of $120.9 million for Q4 2021, a 26% increase year-over-year. GAAP net income stood at $19.8 million or $0.39 per share. For the fiscal year, revenues totaled $437.8 million, up 25%, with GAAP net income of $62.1 million, reflecting the company's strong performance in higher-margin products like Primatene Mist and epinephrine. The company anticipates further growth with multiple pipeline milestones set for 2022.

Positive

• Q4 2021 net revenues increased by 26%, reflecting strong sales growth.
• GAAP net income for Q4 2021 was $19.8 million compared to a loss in Q4 2020.
• Adjusted non-GAAP net income for the year reached $68 million, a significant climb from previous year.
• Sales growth in higher-margin products, such as Primatene Mist and epinephrine, contributed to improved profitability.
• Cash flow from operating activities for the year was $98 million.

Negative

• Decreased sales of enoxaparin by 55% due to lower unit volumes and competitor re-entry.
• API revenues dropped by 64%, attributed to timing of orders.

Reports Net Revenues of $120.9 Million for the Three Months Ended December 31, 2021

RANCHO CUCAMONGA, CA / ACCESSWIRE / March 10, 2022 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) ("Amphastar" or the "Company") today reported results for the three months and full-year ended December 31, 2021.

Fourth Quarter Highlights

• Net revenues of $120.9 million for the fourth quarter
• GAAP net income of $19.8 million, or $0.39 per share, for the fourth quarter
• Adjusted non-GAAP net income of $20.8 million, or $0.42 per share, for the fourth quarter

Full-Year Highlights

• Net revenues of $437.8 million for the fiscal year
• GAAP net income of $62.1 million, or $1.25 per share, for the fiscal year
• Adjusted non-GAAP net income of $68.0 million, or $1.37 per share, for the fiscal year

Dr. Jack Zhang, Amphastar's President and Chief Executive Officer commented: "Last year was a turning point for Amphastar - with financial strength driven by the continued growth of our higher-margin products. We expect a number of pipeline milestones to be reached in 2022 as we continue to execute the Company's strategy."

		Three Months Ended								Year Ended
		December 31,								December 31,
		2021				2020				2021				2020
		(in thousands, except per share data)
Net revenues		$	120,887			$	95,921			$	437,768			$	349,846
GAAP net income (loss) attributable to Amphastar		$	19,760			$	(6,273	)		$	62,116			$	1,403
Adjusted non-GAAP net income attributable to Amphastar*		$	20,833			$	7,994			$	67,999			$	31,616
GAAP diluted EPS attributable to Amphastar stockholders		$	0.39			$	(0.13	)		$	1.25			$	0.03
Adjusted non-GAAP diluted EPS attributable to Amphastar stockholders*		$	0.42			$	0.16			$	1.37			$	0.64

* Adjusted non-GAAP net income attributable to Amphastar and Adjusted non-GAAP diluted EPS attributable to Amphastar stockholders 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.

Fourth Quarter Results

		Three Months Ended
		December 31,								Change
		2021				2020				Dollars				%
		(in thousands)
Net revenues:
Primatene Mist®		$	21,489			$	13,392			$	8,097				60	%
Epinephrine			18,868				7,482				11,386				152	%
Glucagon			15,335				-				15,335				N/A
Phytonadione			13,921				10,458				3,463				33	%
Lidocaine			12,099				12,191				(92	)			(1	)%
Enoxaparin			7,942				17,648				(9,706	)			(55	)%
Naloxone			6,546				7,079				(533	)			(8	)%
Other finished pharmaceutical products			21,776				19,550				2,226				11	%
Total finished pharmaceutical products net revenues		$	117,976			$	87,800			$	30,176				34	%
API			2,911				8,121				(5,210	)			(64	)%
Total net revenues		$	120,887			$	95,921			$	24,966				26	%

Changes in net revenues were primarily driven by:

• Primatene Mist^® increased volumes resulting due to the continued success of our advertising campaign
• Epinephrine sales increased due to our launch of the multi-dose vial in 2020 and higher demand for the pre-filled syringe as a result of competitor shortages
• Glucagon for injection emergency kit, which was launched in the first quarter of 2021
• Phytonadione sales increased due to an increase in unit volumes and higher average selling price
• Enoxaparin sales decreased due to lower unit volumes and lower average selling price as competitors re-entered the market in 2021
• Other finished pharmaceutical product sales increased due to higher demand, largely due to competitors' shortages
• API decrease due to timing of orders from MannKind and other customers

		Three Months Ended
		December 31,								Change
		2021				2020				Dollars				%
		(in thousands)
Net revenues		$	120,887			$	95,921			$	24,966				26%
Cost of revenues			64,653				59,089				5,564				9%
Gross profit		$	56,234			$	36,832			$	19,402				53%
as % of net revenues			47%				38%

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

• Increased sales of higher-margin products such as Primatene Mist^®, epinephrine injection multi-dose vials, and glucagon
• Partially offset by increased cost for heparin, the starting material for enoxaparin, and lower pricing for enoxaparin

		Three Months Ended
		December 31,								Change
		2021				2020				Dollars				%
		(in thousands)
Selling, distribution, and marketing		$	4,075			$	3,787			$	288				8	%
General and administrative			10,621				12,033				(1,412	)			(12	)%
Research and development			17,286				18,133				(847	)			(5	)%
Non-operating income, net			2,910				(9,621	)			12,531				(130	)%

• Selling, distribution, and marketing expenses increased primarily due to the ongoing marketing and distribution expenses for Primatene Mist^®
• General and administrative expenses decreased primarily due to a decrease in legal expenses, as we settled several lawsuits
• Research and development expenses decreased due to a decrease in expenses in China resulting from the restructuring of our Chinese subsidiary, Amphastar Nanjing Pharmaceuticals (ANP), and the deconsolidation of Hanxin and its subsidiaries
• Non-operating income, net, increased as a result of:
  • A $2.7 million gain related to a settlement of a legal dispute, net of contingent legal fees
  • A $12.8 million expense in the fourth quarter of 2020 relating to litigation with Aventis

Year-End Results

		Year Ended December 31,								Change
		2021				2020				Dollars				%
		(in thousands)
Net revenues:
Primatene Mist®		$	73,113			$	51,725			$	21,388				41	%
Epinephrine			57,530				23,799				33,731				142	%
Glucagon			47,639				-				47,639				N/A
Phytonadione			45,498				42,646				2,852				7	%
Lidocaine			44,413				41,113				3,300				8	%
Enoxaparin			35,962				48,681				(12,719	)			(26	)%
Naloxone			27,540				33,416				(5,876	)			(18	)%
Other finished pharmaceutical products			87,875				89,988				(2,113	)			(2	)%
Total finished pharmaceutical products net revenues		$	419,570			$	331,368			$	88,202				27	%
API			18,198				18,478				(280	)			(2	)%
Total net revenues		$	437,768			$	349,846			$	87,922				25	%

Changes in net revenues were primarily driven by:

• Primatene Mist^® increased volumes resulting from the continued success of our advertising campaign
• Glucagon for injection emergency kit, which was launched in the first quarter of 2021
• Epinephrine and lidocaine sales increased due to our launch of the epinephrine multi-dose vials in 2020 and higher demand for the pre-filled syringe as a result of competitor shortages
• Phytonadione sales increased due to higher average selling price
• Enoxaparin and naloxone sales decreased due to lower unit volumes and lower average selling prices as competitors entered the market in 2021
• Other finished pharmaceutical product sales decreased due to lower unit volumes as a result of competitors returning to their normal distribution levels during the year

		Year Ended December 31,								Change
		2021				2020				Dollars				%
		(in thousands)
Net revenues		$	437,768			$	349,846			$	87,922				25%
Cost of revenues			238,029				206,506				31,523				15%
Gross profit		$	199,739			$	143,340			$	56,399				39%
as % of net revenues			46%				41%

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

• Increased sales of higher-margin products such as Primatene Mist^®, epinephrine injection multi-dose vials, and glucagon
• Partially offset by increased cost for heparin, the starting material for enoxaparin, and lower pricing for enoxaparin

		Year Ended December 31,								Change
		2021				2020				Dollars				%
		(in thousands)
Selling, distribution, and marketing		$	17,486			$	14,780			$	2,706				18	%
General and administrative			51,434				50,377				1,057				2	%
Research and development			60,932				67,229				(6,297	)			(9	)%
Non-operating (expense) income, net		$	14,252			$	(6,317	)		$	20,569				NM

• Selling, distribution, and marketing expenses increased primarily due to the ongoing marketing and distribution expenses for Primatene Mist^®, including the cost of developing a new commercial for television
• General and administrative expenses increased primarily due to an increase in legal expenses, which was partially offset by a decrease in cash compensation and share-based compensation expense relating to the separation agreement that we entered into with a former executive during the second quarter of 2020
• Research and development expenses decreased due to:
  • A decrease in clinical trial expense as a result of delays in beginning certain clinical trials due to changes in COVID-19 protocols
  • A decrease in expenses in China due to the restructuring of ANP and the deconsolidation of Hanxin and its subsidiaries
• Non-operating income, net, increased as a result of:
  • A $13.6 million gain on the deconsolidation of Hanxin relating to the ANP restructuring
  • A $2.7 million gain related to a settlement of a legal dispute, net of contingent legal fees
  • A $12.8 million expense in the fourth quarter of 2020 relating to the litigation with Aventis

Cash flow provided by operating activities for the year ended December 31, 2021 was $98.0 million.

Pipeline Information

The Company currently has five ANDAs on file with the FDA targeting products with a market size of approximately $4 billion, three biosimilar products in development targeting products with a market size of approximately $13 billion, and eight generic products in development targeting products with a market size of approximately $12 billion. This market information is based on IQVIA data for the 12 months ended December 31, 2021. The Company is developing multiple proprietary products with injectable and intranasal dosage forms.

Amphastar's Chinese subsidiary, ANP, currently has 17 Drug Master Files, or 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^®, Primatene Mist^®, 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) attributed to Amphastar and (ii) Adjusted non-GAAP diluted EPS attributed to Amphastar's stockholders, which exclude amortization expense, share-based compensation, impairment charges, executive severance expense, 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, March 10, 2022, at 2:00 p.m. Pacific Time.

To access the conference call, dial toll-free (877) 407-0989 or (201) 389-0921 for international callers, five 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, backlog, sales and marketing of our products, market size and growth, 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, our share buyback program, the impact of the restructuring of ANP, and other future events, such as the impact of the COVID-19 pandemic including its variants and related responses of business and governments to the pandemic on our operations and personnel, and on commercial activity and demand across our business operations and results of operations. 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, 2020, filed with the SEC on March 15, 2021, and in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, filed with the SEC on November 9, 2021. In particular, the extent of COVID-19's impact on our business will depend on several factors, including the severity, duration and extent of the pandemic including its variants, as well as actions taken by governments, businesses, and consumers in response to the pandemic, all of which continue to evolve and remain uncertain at this time. 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
(909) 980-9484

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

		Three Months Ended								Year Ended
		December 31,								December 31,
		2021				2020				2021				2020
Net revenues		$	120,887			$	95,921			$	437,768			$	349,846
Cost of revenues			64,653				59,089				238,029				206,506
Gross profit			56,234				36,832				199,739				143,340
Operating expenses:
Selling, distribution, and marketing			4,075				3,787				17,486				14,780
General and administrative			10,621				12,033				51,434				50,377
Research and development			17,286				18,133				60,932				67,229
Total operating expenses			31,982				33,953				129,852				132,386
Income from operations			24,252				2,879				69,887				10,954
Non-operating income (expenses), net			2,910				(9,621	)			14,252				(6,317	)
Income (loss) before income taxes			27,162				(6,742	)			84,139				4,637
Income tax provision (benefit)			7,194				(950	)			20,630				3,540
Net income before equity in losses of unconsolidated affiliate			19,968				(5,792	)			63,509				1,097
Equity in losses of unconsolidated affiliate			(208	)			-				(208	)			-
Net income (loss)		$	19,760			$	(5,792	)		$	63,301			$	1,097
Net income (loss) attributable to non-controlling interests		$	-			$	481			$	1,185			$	(306	)
Net income (loss) attributable to Amphastar		$	19,760			$	(6,273	)		$	62,116			$	1,403
Net income (loss) per share attributable to Amphastar stockholders:
Basic		$	0.41			$	(0.13	)		$	1.30			$	0.03
Diluted		$	0.39			$	(0.13	)		$	1.25			$	0.03
Weighted-average shares used to compute net income (loss) per share attributable to Amphastar stockholders:
Basic			47,836				47,496				47,777				47,038
Diluted			50,057				47,496				49,784				49,124

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

		December 31,				December 31,
		2021				2020
ASSETS
Current assets:
Cash and cash equivalents		$	126,353			$	92,642
Restricted cash			235				1,865
Short-term investments			10,320				12,977
Restricted short-term investments			2,200				2,200
Accounts receivable, net			78,804				66,005
Inventories			92,807				96,831
Income tax refunds and deposits			126				385
Prepaid expenses and other assets			7,274				6,777
Total current assets			318,119				279,682
Property, plant, and equipment, net			244,244				260,055
Finance lease right-of-use assets			353				612
Operating lease right-of-use assets			26,894				20,042
Equity method investment			3,985				-
Goodwill and intangible assets, net			38,870				40,615
Other assets			16,665				5,250
Deferred tax assets			22,399				24,980
Total assets		$	671,529			$	631,236
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued liabilities		$	89,545			$	95,504
Income taxes payable			9,081				1,077
Current portion of long-term debt			2,202				12,263
Current portion of operating lease liabilities			2,982				3,357
Total current liabilities			103,810				112,201
Long-term reserve for income tax liabilities			6,531				4,709
Long-term debt, net of current portion and unamortized debt issuance costs			74,776				34,186
Long-term operating lease liabilities, net of current portion			24,703				17,464
Deferred tax liabilities			534				741
Other long-term liabilities			15,653				13,212
Total liabilities			226,007				182,513
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; 56,440,202 and 47,714,912 shares issued and outstanding as of December 31, 2021 and 54,760,922 and 47,495,439 shares issued and outstanding as of December 31, 2020, respectively			6				5
Additional paid-in capital			422,423				410,061
Retained earnings			180,337				117,773
Accumulated other comprehensive loss			(6,765	)			(3,721	)
Treasury stock			(150,479	)			(121,812	)
Total Amphastar Pharmaceuticals, Inc. stockholders' equity			445,522				402,306
Non-controlling interests			-				46,417
Total equity			445,522				448,723
Total liabilities and stockholders' equity		$	671,529			$	631,236

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

		Three Months Ended								Year Ended
		December 31,								December 31,
		2021				2020				2021				2020
GAAP net income (loss)		$	19,760			$	(5,792	)		$	63,301			$	1,097
Adjusted for:
Intangible amortization			360				265				1,290				1,036
Share-based compensation			3,850				4,334				18,687				18,180
Impairment of long-lived assets			9				81				348				241
Gain on ANP Restructuring			-				-				(13,587	)			-
Expense related to executive separation agreement			-				-				-				4,869
Reserves for litigation and settlements			(2,717	)			13,780				274				13,780
Income tax benefit on pre-tax adjustments			(429	)			(4,090	)			(2,043	)			(7,482	)
Non-GAAP net income		$	20,833			$	8,578			$	68,270			$	31,721
Non-GAAP net income attributable to non-controlling interests		$	-			$	584			$	271			$	105
Non-GAAP net income attributable to Amphastar		$	20,833			$	7,994			$	67,999			$	31,616
Non-GAAP net income per share attributable to Amphastar stockholders:
Basic		$	0.44			$	0.17			$	1.42			$	0.67
Diluted		$	0.42			$	0.16			$	1.37			$	0.64
Weighted-average shares used to compute non-GAAP net income per share attributable to Amphastar stockholders:
Basic			47,836				47,496				47,777				47,038
Diluted			50,057				49,730				49,784				49,124

		Three Months Ended December 31, 2021
		Cost of revenue				Selling, distribution and marketing				General and administrative				Research and development				Non-operating income (expense), net				Income tax provision (benefit)				Non-controlling interest adjustment
GAAP		$	64,653			$	4,075			$	10,621			$	17,286			$	2,910			$	7,194			$	-
Intangible amortization			(235	)			-				(125	)			-				-				-				-
Share-based compensation			(811	)			(158	)			(2,553	)			(328	)			-				-				-
Impairment of long-lived assets			(9	)			-				-				-				-				-				-
Reserves for litigation and settlements			-				-				-				-				(2,717	)			-				-
Income tax provision (benefit) on pre-tax adjustments			-				-				-				-				-				429				-
Non-GAAP		$	63,598			$	3,917			$	7,943			$	16,958			$	193			$	7,623			$	-

		Three Months Ended December 31, 2020
		Cost of revenue				Selling, distribution and marketing				General and administrative				Research and development				Non-operating income (expense), net				Income tax provision (benefit)				Non-controlling interest adjustment
GAAP		$	59,089			$	3,787			$	12,033			$	18,133			$	(9,621	)		$	(950	)		$	481
Intangible amortization			(232	)			-				(33	)			-				-				-				11
Share-based compensation			(972	)			(106	)			(2,920	)			(336	)			-				-				114
Impairment of long-lived assets			(40	)			-				(12	)			(29	)			-				-				5
Loss on litigation settlement			-				-				(975	)			-				12,805				-				-
Income tax provision (benefit) on pre-tax adjustments			-				-				-				-				-				4,090				(27	)
Non-GAAP		$	57,845			$	3,681			$	8,093			$	17,768			$	3,182			$	3,140			$	584

		Year Ended December 31, 2021
		Cost of revenue				Selling, distribution and marketing				General and administrative				Research and development				Non-operating income (expense), net				Income tax provision (benefit)				Non-controlling interest adjustment
GAAP		$	238,029			$	17,486			$	51,434			$	60,932			$	14,252			$	20,630			$	1,185
Intangible amortization			(963	)			-				(327	)			-				-				-				26
Share-based compensation			(3,778	)			(596	)			(12,622	)			(1,691	)			-				-				870
Impairment of long-lived assets			(93	)			-				(33	)			(222	)			-				-				7
Gain on ANP Restructuring			-				-				-				-				(13,587	)			-				(2,062	)
Reserves for litigation and settlements			-				-				(1,295	)			-				(1,021	)			-				-
Income tax provision (benefit) on pre-tax adjustments			-				-				-				-				-				2,043				245
Non-GAAP		$	233,195			$	16,890			$	37,157			$	59,019			$	(356	)		$	22,673			$	271

		Year Ended December 31, 2020
		Cost of revenue				Selling, distribution and marketing				General and administrative				Research and development				Non-operating income (expense), net				Income tax provision (benefit)				Non-controlling interest adjustment
GAAP		$	206,506			$	14,780			$	50,377			$	67,229			$	(6,317	)		$	3,540			$	(306	)
Intangible amortization			(902	)			-				(134	)			-				-				-				45
Share-based compensation			(4,248	)			(456	)			(11,771	)			(1,705	)			-				-				444
Impairment of long-lived assets			(72	)			-				(140	)			(29	)			-				-				20
Expense related to executive separation agreement			-				-				(4,869	)			-				-				-				-
Loss on litigation settlement			-				-				(975	)			-				12,805				-				-
Income tax provision (benefit) on pre-tax adjustments			-				-				-				-				-				7,482				(98	)
Non-GAAP		$	201,284			$	14,324			$	32,488			$	65,495			$	6,488			$	11,022			$	105

SOURCE: Amphastar Pharmaceuticals, Inc.

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FAQ

What were Amphastar's Q4 2021 financial results?

Amphastar reported Q4 2021 net revenues of $120.9 million and GAAP net income of $19.8 million.

How did Amphastar's full-year results compare to 2020?

For the fiscal year 2021, Amphastar recorded net revenues of $437.8 million, up 25% from 2020.

What is the expected outlook for Amphastar in 2022?

Amphastar anticipates reaching several milestones in its pipeline throughout 2022.

What drove revenues for Amphastar in 2021?

Revenue growth was primarily driven by higher-margin products, including Primatene Mist and epinephrine.

What challenges did Amphastar face in 2021?

Challenges included a significant decline in enoxaparin and API sales due to increased competition.