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

Rhea-AI Summary

La Jolla Pharmaceutical Company (Nasdaq: LJPC) reported significant financial progress for the three and nine months ended September 30, 2021. Total revenue reached $13.3 million for Q3 and $63.5 million year-to-date, marking substantial increases from $9.1 million and $22.5 million in 2020. Net product sales were $11.8 million for Q3 and $31.5 million year-to-date, driven by GIAPREZA and XERAVA. Additionally, net cash provided by operating activities improved to $0.8 million for Q3 and $25.1 million year-to-date, highlighting a positive cash flow trend.

Positive

• Net product sales increased to $11.8 million and $31.5 million for Q3 and YTD 2021, up from $9.1 million and $22.5 million in 2020.
• GIAPREZA U.S. net product sales rose to $8.9 million for Q3 2021, an increase of 24% from Q3 2020.
• Positive cash flow of $0.8 million for Q3 2021, marking the third consecutive quarter of positive operating cash flow.
• Net income improved to $15.9 million for the nine months ended September 30, 2021, compared to a loss of $35.9 million in 2020.

Negative

• Net loss of $2.3 million for Q3 2021, although improved from a loss of $11.8 million in Q3 2020.

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 and nine months ended September 30, 2021 and highlighted corporate progress.

Corporate Progress

• Increased Net Product Sales: For the three and nine months ended September 30, 2021, La Jolla’s net product sales were $11.8 million and $31.5 million, respectively, compared to $9.1 million and $22.5 million, respectively, for the same periods in 2020. La Jolla acquired Tetraphase, which commercialized XERAVA, on July 28, 2020. Net product sales for the three and nine months ended September 30, 2020 excludes XERAVA for the period prior to July 28, 2020.
  • GIAPREZA U.S. Net Product Sales: For the three months ended September 30, 2021, GIAPREZA U.S. net product sales were $8.9 million, up 3% from the three months ended June 30, 2021 and up 24% from the three months ended September 30, 2020. For the nine months ended September 30, 2021, GIAPREZA U.S. net product sales were $24.3 million, up 18% from the same period in 2020.
  • XERAVA U.S. Net Product Sales: For the three months ended September 30, 2021, XERAVA U.S. net product sales were $2.9 million, up 16% from the three months ended June 30, 2021 and up 7% from the three months ended September 30, 2020, including the period prior to the acquisition of Tetraphase. For the nine months ended September 30, 2021, XERAVA U.S. net product sales were $7.2 million, up 22% from the same period in 2020, including the period prior to the acquisition of Tetraphase.
• Positive Net Cash Provided by Operating Activities: La Jolla’s net cash provided by (used for) operating activities for the three and nine months ended September 30, 2021 was $0.8 million and $25.1 million, respectively, compared to $(9.8) million and $(30.4) million, respectively, for the same periods in 2020. La Jolla’s net cash provided by (used for) operating activities for the three and nine months ended September 30, 2021, excluding upfront net receipts in connection with out-license agreements and commercial supply agreements, payments related to reductions in headcount, and transaction costs associated with the Tetraphase acquisition, was $1.1 million and $1.5 million, respectively, compared to $(5.6) million and $(21.6) million, respectively, for the same periods in 2020.

“We are pleased to report that La Jolla had a record quarter for net product sales of both GIAPREZA and XERAVA for the three months ended September 30, 2021, and La Jolla had positive operating cash flow for the third consecutive quarter. These are significant achievements for La Jolla,” said Larry Edwards, President and Chief Executive Officer of La Jolla. “La Jolla continues to focus on growing net product sales of both GIAPREZA and XERAVA and generating positive operating cash flow.”

Financial Results

For the three and nine months ended September 30, 2021, La Jolla’s total revenue was $13.3 million and $63.5 million, respectively, compared to $9.1 million and $22.5 million, respectively, for the same periods in 2020. La Jolla’s total revenue was comprised of the following:

• For the three and nine months ended September 30, 2021, La Jolla’s net product sales were $11.8 million and $31.5 million, respectively, compared to $9.1 million and $22.5 million, respectively, for the same periods in 2020. GIAPREZA U.S. net product sales were $8.9 million and $24.3 million for the three and nine months ended September 30, 2021, compared to $7.2 million and $20.6 million, respectively, for the same periods in 2020. XERAVA U.S. net product sales were $2.9 million and $7.2 million for the three and nine months ended September 30, 2021, compared to $1.9 million for the three and nine months ended September 30, 2020.
• For the three and nine months ended September 30, 2021, La Jolla’s license and other revenue was $1.5 million and $32.0 million, respectively, compared to zero for the same periods in 2020.

La Jolla’s net income (loss) for the three and nine months ended September 30, 2021 was $(2.3) million and $15.9 million, or $(0.08) and $0.46 per diluted share, respectively, compared to $(11.8) million and $(35.9) million, or $(0.43) and $(1.32) per diluted share, respectively, for the same periods in 2020.

As of September 30, 2021 and December 31, 2020, La Jolla had cash and cash equivalents of $46.8 million and $21.2 million, respectively. La Jolla’s net cash provided by (used for) operating activities for the three and nine months ended September 30, 2021 was $0.8 million and $25.1 million, respectively, compared to $(9.8) million and $(30.4) million, respectively, for the same periods in 2020.

La Jolla’s net cash provided by (used for) operating activities for the three and nine months ended September 30, 2021, excluding upfront net receipts in connection with out-license agreements and commercial supply agreements, payments related to reductions in headcount, and transaction costs associated with the Tetraphase acquisition, was $1.1 million and $1.5 million, respectively, compared to $(5.6) million and $(21.6) million, respectively, for the same periods in 2020. The exclusions above are comprised of the following:

• Upfront net receipts in connection with out-license agreements were zero and $18.4 million for the three and nine months ended September 30, 2021, respectively, and zero for the same periods in 2020.
• Upfront net receipts in connection with commercial supply agreements were zero and $6.8 million for the three and nine months ended September 30, 2021, and zero for the same periods in 2020.
• Payments related to reductions in headcount were $0.3 million and $1.6 million for the three and nine months ended September 30, 2021, respectively, and $3.3 million and $7.9 million, respectively, for the same periods in 2020.
• Payments related to transaction costs associated with the Tetraphase acquisition were zero for the three and nine months ended September 30, 2021, and $0.9 million for the three and nine months ended September 30, 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)
		September 30,				December 31,
		2021				2020
		(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents		$	46,765			$	21,221
Accounts receivable, net			8,793				5,834
Inventory, net			6,094				6,013
Prepaid expenses and other current assets			4,263				3,388
Total current assets			65,915				36,456
Goodwill			20,123				20,123
Intangible assets, net			13,709				14,873
Right-of-use lease assets			367				536
Property and equipment, net			140				215
Restricted cash			40				40
Total assets		$	100,294			$	72,243
LIABILITIES AND SHAREHOLDERS’ DEFICIT
Current liabilities:
Accounts payable		$	2,314			$	2,762
Accrued expenses			11,720				6,494
Accrued payroll and related expenses			1,801				2,878
Lease liabilities, current portion			160				204
Total current liabilities			15,995				12,338
Deferred royalty obligation, net			124,487				124,437
Accrued interest expense on deferred royalty obligation, less current portion			23,489				19,111
Lease liabilities, less current portion			208				332
Other noncurrent liabilities			4,523				4,112
Total liabilities			168,702				160,330
Commitments and contingencies
Shareholders’ deficit:
Common Stock, $0.0001 par value; 100,000,000 shares authorized, 27,518,191 and 27,402,648 shares issued and outstanding at September 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 September 30, 2021 and December 31, 2020; and liquidation preference of $3,906 at September 30, 2021 and December 31, 2020			3,906				3,906
Additional paid-in capital			988,544				984,756
Accumulated deficit			(1,060,861	)			(1,076,752	)
Total shareholders’ deficit			(68,408	)			(88,087	)
Total liabilities and shareholders’ deficit		$	100,294			$	72,243

LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share amounts)
		Three Months Ended								Nine Months Ended
		September 30,								September 30,
		2021				2020				2021				2020
Revenue
Net product sales		$	11,781			$	9,072			$	31,477			$	22,468
License and other revenue			1,533				-				32,033				-
Total revenue			13,314				9,072				63,510				22,468
Operating expenses
Cost of product sales			2,031				2,489				6,918				4,013
Cost of license and other revenue			841				-				4,441				-
Selling, general and administrative			8,632				12,493				26,383				29,322
Research and development			1,285				3,617				3,957				21,581
Total operating expenses			12,789				18,599				41,699				54,916
Income (loss) from operations			525				(9,527	)			21,811				(32,448	)
Other (expense) income
Interest expense			(2,729	)			(2,526	)			(8,010	)			(7,402	)
Interest income			-				12				2				234
Other income—related party			-				-				2,532				4,085
Other (expense) income			(25	)			281				(395	)			(412	)
Total other (expense) income, net			(2,754	)			(2,233	)			(5,871	)			(3,495	)
Income (loss) before income taxes			(2,229	)			(11,760	)			15,940				(35,943	)
Provision for income taxes			31				-				49				-
Net income (loss)		$	(2,260	)		$	(11,760	)		$	15,891			$	(35,943	)
Earnings (loss) per share
Basic		$	(0.08	)		$	(0.43	)		$	0.58			$	(1.32	)
Diluted		$	(0.08	)		$	(0.43	)		$	0.46			$	(1.32	)
Shares used in computing earnings (loss) per share
Basic			27,497				27,368				27,462				27,311
Diluted			27,497				27,368				34,206				27,311

LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(in thousands)
		Nine Months Ended
		September 30,
		2021				2020
Operating activities
Net income (loss)		$	15,891			$	(35,943	)
Adjustments to reconcile net income (loss) to net cash provided by (used for) operating activities:
Share-based compensation expense			3,315				5,385
Depreciation expense			84				2,155
Non-cash interest expense			5,587				5,339
Inventory fair value step-up adjustment included in cost of product sales			850				1,186
Amortization of intangible assets			1,164				259
Loss on change in fair value of contingent value rights			395				-
Amortization of right-of-use lease assets			169				1,091
Loss on short-term investments			-				502
Loss on disposal of property and equipment, net of gain on lease termination			-				59
Changes in operating assets and liabilities:
Accounts receivable, net			(2,959	)			218
Inventory, net			(931	)			(1,482	)
Prepaid expenses and other current assets			(875	)			2,445
Accounts payable			(448	)			(1,649	)
Accrued expenses			4,083				(5,786	)
Accrued payroll and related expenses			(1,077	)			(2,168	)
Lease liabilities			(168	)			(1,969	)
Net cash provided by (used for) operating activities			25,080				(30,358	)
Investing activities
Acquisition of Tetraphase, net of cash, cash equivalents and restricted cash acquired			-				(33,513	)
Proceeds from the sale of property and equipment			-				3,070
Purchases of property and equipment			(9	)			-
Proceeds from the sale of short-term investments			-				2,497
Purchases of short-term investments			-				(2,999	)
Net cash used for investing activities			(9	)			(30,945	)
Financing activities
Net proceeds from issuance of common stock under ESPP			317				428
Net proceeds from issuance of common stock under 2013 Equity Plan			156				605
Net cash provided by financing activities			473				1,033
Net increase (decrease) in cash, cash equivalents and restricted cash			25,544				(60,270	)
Cash, cash equivalents and restricted cash, beginning of period			21,261				88,729
Cash, cash equivalents and restricted cash, end of period		$	46,805			$	28,459
Reconciliation of cash, cash equivalents and restricted cash to the condensed consolidated balance sheets
Cash and cash equivalents		$	46,765			$	27,760
Restricted cash			40				699
Total cash, cash equivalents and restricted cash		$	46,805			$	28,459

 

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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 were La Jolla Pharmaceutical Company's Q3 2021 net product sales?

La Jolla's Q3 2021 net product sales were $11.8 million.

How did La Jolla's total revenue for the nine months ended September 30, 2021 compare to 2020?

Total revenue for the nine months ended September 30, 2021 was $63.5 million, compared to $22.5 million for the same period in 2020.

What was the performance of GIAPREZA in Q3 2021?

GIAPREZA achieved U.S. net product sales of $8.9 million in Q3 2021, a 24% increase compared to Q3 2020.

How much cash did La Jolla generate from operating activities in Q3 2021?

La Jolla generated $0.8 million in cash from operating activities in Q3 2021.

What was La Jolla's net income for the nine months ended September 30, 2021?

La Jolla reported a net income of $15.9 million for the nine months ended September 30, 2021.