La Jolla Pharmaceutical Company Announces Financial Results for the Three and Six Months Ended June 30, 2021 and Highlights Corporate Progress

Rhea-AI Summary

La Jolla Pharmaceutical Company (Nasdaq: LJPC) reported significant financial growth for the second quarter and first half of 2021, with total revenues reaching $16.1 million and $50.2 million, respectively. This marks a substantial increase from $5.8 million and $13.4 million in the same periods of 2020. Net product sales grew to $11.1 million and $19.7 million, driven by a 48% increase in GIAPREZA net sales and a 67% rise in XERAVA's sales. The company achieved net income of $3.7 million in Q2 2021, a turnaround from a loss of $15.6 million a year prior.

Positive

• Total revenue increased to $16.1 million for Q2 2021, up from $5.8 million in Q2 2020.
• Net product sales for Q2 2021 rose to $11.1 million, compared to $5.8 million in Q2 2020.
• GIAPREZA U.S. net sales were $8.6 million for Q2 2021, an increase of 48% from Q2 2020.
• XERAVA U.S. net sales reached $2.5 million for Q2 2021, up 67% from Q2 2020.
• Net income of $3.7 million for Q2 2021, compared to a net loss of $15.6 million in Q2 2020.

Negative

• None.

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 and six months ended June 30, 2021 and highlighted corporate progress.

Corporate Progress

• Positive Net Cash Provided by Operating Activities: La Jolla’s net cash provided by (used for) operating activities for the three and six months ended June 30, 2021 was $7.1 million and $24.3 million, respectively, compared to $(8.4) million and $(20.6) million, respectively, for the same periods in 2020. La Jolla’s net cash provided by (used for) operating activities for the three and six months ended June 30, 2021, excluding net receipts in connection with out-license agreements, commercial supply agreements and payments related to reductions in headcount, was $2.2 million and $0.4 million, respectively, compared to $(6.7) million and $(16.0) million, respectively, for the same periods in 2020.
• Increased Net Product Sales: For the three and six months ended June 30, 2021, La Jolla’s net product sales were $11.1 million and $19.7 million, respectively, compared to $5.8 million and $13.4 million, respectively, for the same periods in 2020. La Jolla acquired Tetraphase, which commercialized XERAVA, on July 28, 2020. Net product sales excludes XERAVA for the three and six months ended June 30, 2020.
  • GIAPREZA U.S. Net Sales: For the three months ended June 30, 2021, GIAPREZA U.S. net sales were $8.6 million, up 25% from the three months ended March 31, 2021 and up 48% from the three months ended June 30, 2020. For the six months ended June 30, 2021, GIAPREZA U.S. net sales were $15.4 million, up 15% from the same period in 2020.
  • XERAVA U.S. Net Sales: For the three months ended June 30, 2021, XERAVA U.S. net sales were $2.5 million, up 39% from the three months ended March 31, 2021 and up 67% from the three months ended June 30, 2020, including the period prior to the acquisition of Tetraphase. For the six months ended June 30, 2021, XERAVA U.S. net sales were $4.3 million, up 34% from the same period in 2020, including the period prior to the acquisition of Tetraphase.

“We are pleased to report that La Jolla had positive net cash provided by operating activities for the three and six months ended June 30, 2021. We believe this is a significant achievement,” said Larry Edwards, President and Chief Executive Officer of La Jolla. “La Jolla continues to focus on growing net sales of both GIAPREZA and XERAVA while managing operating costs. We believe we are well-positioned to serve the needs of patients suffering from life-threatening diseases.”

Financial Results

For the three and six months ended June 30, 2021, La Jolla’s total revenue was $16.1 million and $50.2 million, respectively, compared to $5.8 million and $13.4 million, respectively, for the same periods in 2020. For the three and six months ended June 30, 2021, La Jolla’s net product sales were $11.1 million and $19.7 million, respectively, compared to $5.8 million and $13.4 million, respectively, for the same periods in 2020. GIAPREZA U.S. net sales were $8.6 million and $15.4 million for the three and six months ended June 30, 2021, compared to $5.8 million and $13.4 million, respectively, for the same periods in 2020. XERAVA U.S. net sales were $2.5 million and $4.3 million for the three and six months ended June 30, 2021, compared to zero for the same periods in 2020. For the three and six months ended June 30, 2021, La Jolla’s license revenue was $5.0 million and $30.5 million, respectively, compared to zero for the same periods in 2020.

La Jolla’s net income (loss) for the three and six months ended June 30, 2021 was $3.7 million and $18.2 million, or $0.11 and $0.53 per diluted share, respectively, compared to $(15.6) million and $(24.2) million, or $(0.57) and $(0.89) per diluted share, respectively, for the same periods in 2020.

As of June 30, 2021 and December 31, 2020, La Jolla had cash and cash equivalents of $45.9 million and $21.2 million, respectively. La Jolla’s net cash provided by (used for) operating activities for the three and six months ended June 30, 2021 was $7.1 million and $24.3 million, respectively, compared to $(8.4) million and $(20.6) million, respectively, for the same periods in 2020.

La Jolla’s net cash provided by (used for) operating activities for the three and six months ended June 30, 2021, excluding net receipts in connection with out-license agreements, commercial supply agreements and payments related to reductions in headcount, was $2.2 million and $0.4 million, respectively, compared to $(6.7) million and $(16.0) million, respectively, for the same periods in 2020. Net receipts (payments) in connection with out-license agreements were $(1.4) million and $18.4 million for the three and six months ended June 30, 2021, respectively, and zero for the same periods in 2020. Net receipts in connection with commercial supply agreements were $6.8 million for the three and six months ended June 30, 2021, and zero for the same periods in 2020. Payments related to reductions in headcount were $0.5 million and $1.3 million for the three and six months ended June 30, 2021, respectively, and $1.6 million and $4.6 million, respectively, for the same periods in 2020.

La Jolla’s consolidated financial results for the three and six months ended June 30, 2020 exclude the financial results of Tetraphase. La Jolla acquired Tetraphase, which commercialized XERAVA, on July 28, 2020.

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 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)
		June 30,				December 31,
		2021				2020
		(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents		$	45,888			$	21,221
Accounts receivable, net			8,596				5,834
Inventory, net			5,481				6,013
Prepaid expenses and other current assets			5,201				3,388
Total current assets			65,166				36,456
Goodwill			20,123				20,123
Intangible assets, net			14,097				14,873
Right-of-use lease assets			419				536
Property and equipment, net			163				215
Restricted cash			40				40
Total assets		$	100,008			$	72,243
LIABILITIES AND SHAREHOLDERS’ DEFICIT
Current liabilities:
Accounts payable		$	1,846			$	2,762
Accrued expenses			12,175				6,494
Accrued payroll and related expenses			1,912				2,878
Lease liabilities, current portion			168				204
Total current liabilities			16,101				12,338
Deferred royalty obligation, net			124,470				124,437
Accrued interest expense on deferred royalty obligation, less current portion			22,136				19,111
Lease liabilities, less current portion			251				332
Other noncurrent liabilities			4,493				4,112
Total liabilities			167,451				160,330
Commitments and contingencies
Shareholders’ deficit:
Common Stock, $0.0001 par value; 100,000,000 shares authorized, 27,482,231 and 27,402,648 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively			3				3
Series C-12 Convertible Preferred Stock, $0.0001 par value; 11,000 shares authorized, 3,906 shares issued and outstanding at June 30, 2021 and December 31, 2020; and liquidation preference of $3,906 at June 30, 2021 and December 31, 2020			3,906				3,906
Additional paid-in capital			987,249				984,756
Accumulated deficit			(1,058,601	)			(1,076,752	)
Total shareholders’ deficit			(67,443	)			(88,087	)
Total liabilities and shareholders’ deficit		$	100,008			$	72,243

LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share amounts)
		Three Months Ended								Six Months Ended
		June 30,								June 30,
		2021				2020				2021				2020
Revenue
Net product sales		$	11,059			$	5,805			$	19,696			$	13,396
License revenue			5,000				-				30,500				-
Total revenue			16,059				5,805				50,196				13,396
Operating expenses
Cost of product sales			2,156				808				4,887				1,524
Cost of license revenue			-				-				3,600				-
Selling, general and administrative			8,996				8,677				17,751				16,829
Research and development			1,114				8,781				2,672				17,964
Total operating expenses			12,266				18,266				28,910				36,317
Income (loss) from operations			3,793				(12,461	)			21,286				(22,921	)
Other (expense) income
Interest expense			(2,672	)			(2,470	)			(5,281	)			(4,876	)
Interest income			-				32				2				222
Other income—related party			2,532				-				2,532				4,085
Other income (expense)			80				(693	)			(370	)			(693	)
Total other (expense) income, net			(60	)			(3,131	)			(3,117	)			(1,262	)
Income (loss) before income taxes			3,733				(15,592	)			18,169				(24,183	)
Provision for income taxes			-				-				18				-
Net income (loss)		$	3,733			$	(15,592	)		$	18,151			$	(24,183	)
Earnings (loss) per share
Basic		$	0.14			$	(0.57	)		$	0.66			$	(0.89	)
Diluted		$	0.11			$	(0.57	)		$	0.53			$	(0.89	)
Shares used in computing earnings (loss) per share
Basic			27,461				27,326				27,444				27,282
Diluted			34,201				27,326				34,192				27,282

LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(in thousands)
		Six Months Ended
		June 30,
		2021				2020
Operating activities
Net income (loss)		$	18,151			$	(24,183	)
Adjustments to reconcile net income (loss) to net cash provided by (used for) operating activities:
Share-based compensation expense			2,140				3,997
Depreciation expense			56				1,798
Non-cash interest expense			3,718				3,392
Inventory fair value step-up adjustment included in cost of product sales			850				-
Amortization of intangible assets			776				-
Loss on change in fair value of contingent value rights			370				-
Amortization of right-of-use lease assets			117				699
Loss on disposal of property and equipment			-				904
Unrealized gains on short-term investments			-				(63	)
Changes in operating assets and liabilities:
Accounts receivable, net			(2,762	)			1,117
Inventory, net			(318	)			(909	)
Prepaid expenses and other current assets			(1,813	)			1,675
Accounts payable			(920	)			(1,696	)
Accrued expenses			5,032				(3,378	)
Accrued payroll and related expenses			(966	)			(2,591	)
Lease liabilities			(117	)			(1,357	)
Net cash provided by (used for) operating activities			24,314				(20,595	)
Investing activities
Proceeds from the sale of property and equipment			-				2,860
Purchases of short-term investments			-				(2,999	)
Net cash used for investing activities			-				(139	)
Financing activities
Net proceeds from issuance of common stock under 2013 Equity Plan			155				605
Net proceeds from issuance of common stock under ESPP			198				359
Net cash provided by financing activities			353				964
Net increase (decrease) in cash, cash equivalents and restricted cash			24,667				(19,770	)
Cash, cash equivalents and restricted cash, beginning of period			21,261				88,729
Cash, cash equivalents and restricted cash, end of period		$	45,928			$	68,959
Reconciliation of cash, cash equivalents and restricted cash to the condensed consolidated balance sheets
Cash and cash equivalents		$	45,888			$	68,353
Restricted cash			40				606
Total cash, cash equivalents and restricted cash		$	45,928			$	68,959

 

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FAQ

What were La Jolla's financial results for Q2 2021?

La Jolla reported total revenues of $16.1 million for Q2 2021, with net product sales of $11.1 million.

How did GIAPREZA perform in the second quarter of 2021?

GIAPREZA U.S. net sales reached $8.6 million in Q2 2021, reflecting a 48% increase compared to Q2 2020.

What was the net income for La Jolla Pharmaceutical in Q2 2021?

La Jolla had a net income of $3.7 million in Q2 2021, a notable improvement from a loss of $15.6 million in the same period of 2020.

How much cash did La Jolla have at the end of June 2021?

As of June 30, 2021, La Jolla had cash and cash equivalents amounting to $45.9 million.

What was the growth in XERAVA net sales for Q2 2021?

XERAVA U.S. net sales were $2.5 million for Q2 2021, representing a 67% increase from Q2 2020.