La Jolla Pharmaceutical Company Announces Financial Results for the Three Months Ended March 31, 2022 and Highlights Corporate Progress

Rhea-AI Summary

La Jolla Pharmaceutical Company (LJPC) reported a net product sales increase of 21% to $10.4 million for Q1 2022, driven by GIAPREZA and XERAVA. GIAPREZA U.S. sales rose 13% to $7.7 million, while XERAVA sales surged 50% to $2.7 million. However, total revenue fell to $10.4 million from $34.1 million in Q1 2021, impacted by prior year upfront payments totaling $22.5 million. Net income decreased to approximately $2,000, or $0.00 per diluted share, from $14.4 million, or $0.42 per share, in the same quarter last year. Cash reserves stood at $44.6 million, down from $46.7 million.

Positive

• Net product sales increased by 21% year-over-year.
• GIAPREZA U.S. net sales grew by 13%.

Negative

• Total revenue declined to $10.4 million from $34.1 million in Q1 2021.
• Net income significantly decreased to approximately $2,000 from $14.4 million.

WALTHAM, Mass.--(BUSINESS WIRE)-- La Jolla Pharmaceutical Company (Nasdaq: LJPC), which is dedicated to the commercialization of innovative therapies that improve outcomes in patients suffering from life-threatening diseases, today announced financial results for the three months ended March 31, 2022 and highlighted corporate progress.

Corporate Progress

• Net Product Sales: For the three months ended March 31, 2022, La Jolla’s net product sales were $10.4 million, up 21% from the same period in 2021.
  • GIAPREZA U.S. Net Product Sales: For the three months ended March 31, 2022, GIAPREZA U.S. net product sales were $7.7 million, up 13% from the same period in 2021.
  • XERAVA U.S. Net Product Sales: For the three months ended March 31, 2022, XERAVA U.S. net product sales were $2.7 million, up 50% from the same period in 2021.
• Positive Net Cash Provided by Operating Activities: For the three months ended March 31, 2022, La Jolla’s net cash provided by operating activities was $2.5 million compared to $17.2 million for the same period in 2021. The 2021 period included a $16.8 million net upfront payment and a $3.0 million milestone payment received in connection with the Company’s agreements with PAION AG and Everest Medicines Limited covering ex-U.S. rights to GIAPREZA and XERAVA.

“We are pleased to report that La Jolla continues to grow net product sales and generate positive operating cash flow,” said Larry Edwards, President and Chief Executive Officer of La Jolla. “La Jolla’s focus remains on growing its GIAPREZA and XERAVA franchises while increasing operating cash flow.”

Financial Results

For the three months ended March 31, 2022, La Jolla’s total revenue was $10.4 million compared to $34.1 million for the same period in 2021. The 2021 period included a $22.5 million upfront payment and a $3.0 million milestone payment received in connection with the Company’s agreements with PAION AG and Everest Medicines Limited covering ex-U.S. rights to GIAPREZA and XERAVA. For the three months ended March 31, 2022, La Jolla’s net product sales were $10.4 million compared to $8.6 million for the same period in 2021, an increase of 21%. GIAPREZA U.S. net product sales were $7.7 million for the three months ended March 31, 2022 compared to $6.8 million for the same period in 2021, an increase of 13%. XERAVA U.S. net product sales were $2.7 million for the three months ended March 31, 2022 compared to $1.8 million for the same period in 2021, an increase of 50%.

For the three months ended March 31, 2022, La Jolla’s net income was approximately $2,000, or $0.00 per diluted share, compared to $14.4 million, or $0.42 per diluted share, for the same period in 2021.

As of March 31, 2022, La Jolla had $44.6 million of cash, cash equivalents and short-term investments compared to $46.7 million as of December 31, 2021. The $2.1 million decrease in cash, cash equivalents and short-term investments is primarily due to $2.5 million of net cash provided by operating activities, offset by $5.2 million in purchases of the Company’s common stock under its stock repurchase plan. For the three months ended March 31, 2022, La Jolla’s net cash provided by operating activities was $2.5 million compared to $17.2 million for the same period in 2021. The 2021 period included a $16.8 million net upfront payment and a $3.0 million milestone payment received in connection with the Company’s agreements with PAION AG and Everest Medicines Limited covering ex-U.S. rights to GIAPREZA and XERAVA.

About GIAPREZA

GIAPREZA^® (angiotensin II) injection is approved by the U.S. Food and Drug Administration (FDA) as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. GIAPREZA is approved by the European Commission (EC) for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies. GIAPREZA mimics the body’s endogenous angiotensin II peptide, which is central to the renin-angiotensin-aldosterone system, which in turn regulates blood pressure. Prescribing information for GIAPREZA is available at www.giapreza.com. The European Summary of Product Characteristics is available at www.ema.europa.eu/en/medicines/human/EPAR/giapreza. GIAPREZA is marketed in the U.S. by La Jolla Pharmaceutical Company on behalf of La Jolla Pharma, LLC, its wholly owned subsidiary, and is marketed in Europe by PAION Deutschland GmbH on behalf of La Jolla Pharma, LLC.

GIAPREZA Important Safety Information

Contraindications

None.

Warnings and Precautions

There is a potential for venous and arterial thrombotic and thromboembolic events in patients who receive GIAPREZA. Use concurrent venous thromboembolism (VTE) prophylaxis.

Adverse Reactions

The most common adverse reactions that were reported in greater than 10% of GIAPREZA-treated patients were thromboembolic events.

Drug Interactions

Angiotensin converting enzyme (ACE) inhibitors may increase response to GIAPREZA. Angiotensin II receptor blockers (ARBs) may reduce response to GIAPREZA.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For additional information, please see Full Prescribing Information for the United States and the Summary of Product Characteristics for the European Union.

About XERAVA

XERAVA^® (eravacycline) for injection is approved by the U.S. Food and Drug Administration (FDA) as a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years of age and older. XERAVA is approved by the European Commission (EC) for the treatment of cIAI in adults. Prescribing information for XERAVA is available at www.xerava.com. The European Summary of Product Characteristics is available at www.ema.europa.eu/en/medicines/human/EPAR/xerava. XERAVA is marketed in the U.S. by Tetraphase Pharmaceuticals, Inc., a wholly owned subsidiary of La Jolla, and is marketed in Europe by PAION Deutschland GmbH on behalf of Tetraphase Pharmaceuticals, Inc. Everest, the Company’s licensee for mainland China, Taiwan, Hong Kong, Macau, South Korea, Singapore, the Malaysian Federation, the Kingdom of Thailand, the Republic of Indonesia, the Socialist Republic of Vietnam and the Republic of the Philippines, submitted an NDA in China, which was accepted by the China National Medical Products Administration (NMPA) in March 2021. XERAVA was approved in Singapore by the Health Science Authority in April 2020.

XERAVA Important Safety Information

XERAVA is a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections in patients 18 years of age and older.

XERAVA is not indicated for the treatment of complicated urinary tract infections.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs or to any of the excipients. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA.

The use of XERAVA during tooth development (last half of pregnancy, infancy and childhood to the age of eight years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

The use of XERAVA during the second and third trimester of pregnancy, infancy and childhood up to the age of eight years may cause reversible inhibition of bone growth.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis.

The most common adverse reactions observed in clinical trials (incidence ≥ 3%) were infusion site reactions, nausea and vomiting.

XERAVA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri and anti-anabolic action, which has led to increased blood urea nitrogen, azotemia, acidosis, hyperphosphatemia, pancreatitis and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with XERAVA. Discontinue XERAVA if any of these adverse reactions are suspected.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For additional information, please see Full Prescribing Information for the United States.

About La Jolla Pharmaceutical Company

La Jolla Pharmaceutical Company is dedicated to the commercialization of innovative therapies that improve outcomes in patients suffering from life-threatening diseases. GIAPREZA^® (angiotensin II) injection is approved by the FDA as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. XERAVA^® (eravacycline) for injection is approved by the FDA as a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years of age and older. For more information, please visit www.ljpc.com.

Forward-looking Statements

This press release contains “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995. We caution investors that forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and involve substantial risks and uncertainties that could cause the actual outcomes to differ materially from what we currently expect. These risks and uncertainties include, but are not limited to, those associated with: GIAPREZA^® (angiotensin II) and XERAVA^® (eravacycline) sales; operating costs; regulatory actions relating to La Jolla’s products by the U.S. FDA, European Commission, China National Medical Products Administration and/or other regulatory authorities; expected future cash flows of La Jolla, including upfront, milestone, royalty and other payments resulting from La Jolla’s out-license agreements and commercial supply agreements; and other risks and uncertainties identified in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements in this press release apply only as of the date made, and we undertake no obligation to update or revise any forward-looking statements to reflect subsequent events or circumstances.

LA JOLLA PHARMACEUTICAL COMPANY Condensed Consolidated Balance Sheets (in thousands, except par value and share amounts)
		March 31,				December 31,
		2022				2021
		(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents		$	44,169			$	46,668
Short-term investments			390				-
Accounts receivable, net			5,729				8,610
Inventory, net			7,113				6,281
Prepaid expenses and other current assets			5,518				5,756
Total current assets			62,919				67,315
Goodwill			20,123				20,123
Intangible assets, net			12,933				13,321
Right-of-use lease assets			275				318
Property and equipment, net			88				113
Restricted cash			40				40
Total assets		$	96,378			$	101,230
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable		$	2,789			$	2,278
Accrued expenses			4,297				4,866
Accrued interest expense on deferred royalty obligation, current portion			5,957				5,163
Deferred revenue			2,849				2,849
Paycheck Protection Program loan			-				2,325
Lease liabilities, current portion			156				154
Total current liabilities			16,048				17,635
Deferred royalty obligation, net			124,519				124,503
Accrued interest expense on deferred royalty obligation, less current portion			25,262				24,590
Lease liabilities, less current portion			120				164
Fair value of contingent value rights			923				1,076
Total liabilities			166,872				167,968
Commitments and contingencies
Stockholders’ deficit:
Common Stock, $0.0001 par value; 100,000,000 shares authorized, 25,663,667 and 26,783,544 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively			3				3
Series C-12 Convertible Preferred Stock, $0.0001 par value; 11,000 shares authorized, 3,906 shares issued and outstanding at March 31, 2022 and December 31, 2021; and liquidation preference of $3,906 at March 31, 2022 and December 31, 2021			3,906				3,906
Additional paid-in capital			982,687				986,445
Accumulated deficit			(1,057,090	)			(1,057,092	)
Total stockholders’ deficit			(70,494	)			(66,738	)
Total liabilities and stockholders’ deficit		$	96,378			$	101,230

LA JOLLA PHARMACEUTICAL COMPANY Condensed Consolidated Statements of Operations (Unaudited) (in thousands, except per share amounts)
		Three Months Ended
		March 31,
		2022				2021
Revenue
Net product sales		$	10,409			$	8,637
License and other revenue			16				25,500
Total revenue			10,425				34,137
Operating expenses
Cost of product sales			2,165				2,731
Cost of license and other revenue			5				3,600
Selling, general and administrative			10,274				8,755
Research and development			27				1,558
Total operating expenses			12,471				16,644
(Loss) income from operations			(2,046	)			17,493
Other income (expense)
Interest expense			(2,402	)			(2,609	)
Gain on forgiveness of Paycheck Protection Program loan			2,325				-
Other income—related party			1,583				-
Other income (expense)			543				(448	)
Total other income (expense), net			2,049				(3,057	)
Income before income taxes			3				14,436
Provision for income taxes			1				18
Net income		$	2			$	14,418
Earnings per share
Basic		$	0.00			$	0.53
Diluted		$	0.00			$	0.42
Shares used in computing earnings per share
Basic			26,163				27,427
Diluted			32,916				34,183

LA JOLLA PHARMACEUTICAL COMPANY Condensed Consolidated Statements of Cash Flows (Unaudited) (in thousands)
		Three Months Ended
		March 31,
		2022				2021
Operating activities
Net income		$	2			$	14,418
Adjustments to reconcile net income to net cash provided by operating activities:
Non-cash interest expense			1,482				1,736
Share-based compensation expense			1,262				1,116
Amortization of intangible assets			388				388
Amortization of right-of-use lease assets			43				46
Depreciation expense			25				29
Loss on short-term investments			309				-
Gain on forgiveness of Paycheck Protection Program loan			(2,325	)			-
Gain on sale of non-controlling equity interest			(699	)			-
(Gain) loss on change in fair value of contingent value rights			(153	)			450
Inventory fair value step-up adjustment included in cost of product sales			-				850
Changes in operating assets and liabilities:
Accounts receivable, net			2,881				1,681
Inventory, net			(832	)			(211	)
Prepaid expenses and other current assets			238				(2,716	)
Accounts payable			511				(1,664	)
Accrued expenses			(569	)			1,101
Lease liabilities			(42	)			(46	)
Net cash provided by operating activities			2,521				17,178
Investing activities
Net cash provided by (used for) investing activities			-				-
Financing activities
Purchases of common stock under Stock Repurchase Plan			(5,179	)			-
Net proceeds from issuance of common stock under ESPP			159				81
Net proceeds from issuance of common stock under 2013 Equity Plan			-				154
Net cash (used for) provided by financing activities			(5,020	)			235
Net (decrease) increase in cash, cash equivalents and restricted cash			(2,499	)			17,413
Cash, cash equivalents and restricted cash, beginning of period			46,708				21,261
Cash, cash equivalents and restricted cash, end of period		$	44,209			$	38,674
Supplemental disclosure of non-cash investing and financing activities
Sale of non-controlling equity interest		$	699			$	-
Forgiveness of Paycheck Protection Program loan		$	2,325			$	-
Reconciliation of cash, cash equivalents and restricted cash to the condensed consolidated balance sheets
Cash and cash equivalents		$	44,169			$	38,634
Restricted cash			40				40
Total cash, cash equivalents and restricted cash		$	44,209			$	38,674

 

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La Jolla Pharmaceutical Company Contact

Michael Hearne

Chief Financial Officer

La Jolla Pharmaceutical Company

(617) 715-3598

mhearne@ljpc.com

Source: La Jolla Pharmaceutical Company

FAQ

What are La Jolla Pharmaceutical Company's earnings results for Q1 2022?

La Jolla reported net product sales of $10.4 million for Q1 2022, with a net income of approximately $2,000.

How did GIAPREZA and XERAVA perform in Q1 2022?

GIAPREZA U.S. net sales increased by 13% to $7.7 million, while XERAVA U.S. net sales surged by 50% to $2.7 million.

What was La Jolla's financial performance compared to Q1 2021?

Total revenue dropped from $34.1 million in Q1 2021 to $10.4 million in Q1 2022, primarily due to earlier upfront payments.

What financial metrics should investors note from La Jolla's Q1 2022 report?

Investors should note the significant decrease in net income and total revenue, alongside positive sales growth for its products.