La Jolla Pharmaceutical Company Announces Financial Results for the Three and Twelve Months Ended December 31, 2021 and Highlights Corporate Progress
La Jolla Pharmaceutical Company (Nasdaq: LJPC) reported record net product sales of $12.1 million for Q4 2021 and $43.5 million for the full year, up from $11.0 million and $33.4 million in 2020. Notably, GIAPREZA sales increased to $9.2 million in Q4, while XERAVA sales reached $2.9 million. La Jolla achieved positive operating cash flow for the fourth consecutive quarter, amounting to $3.1 million for Q4 and $28.2 million for the year, a significant turnaround from the prior year's losses. The company reported net income of $3.8 million for Q4 and $19.7 million for the full year, compared to losses in 2020.
- Record net product sales of $12.1 million for Q4 2021 and $43.5 million for the full year, up 10% and 30% respectively from 2020.
- GIAPREZA sales increased by 6% to $9.2 million for Q4 2021 and 14% to $33.4 million for the full year.
- XERAVA sales rose by 26% to $2.9 million for Q4 2021 and 23% to $10.1 million for the full year.
- Positive net cash from operating activities of $3.1 million for Q4 and $28.2 million for the full year, reversing prior year losses.
- Net income of $3.8 million for Q4 and $19.7 million for the full year, a significant improvement from $3.5 million and $39.4 million losses in 2020.
- None.
Corporate Progress
-
Record Fourth Quarter and Full Year Net Product Sales: La Jolla had record net product sales for the three and twelve months ended
December 31, 2021 . For the three and twelve months endedDecember 31, 2021 , La Jolla’s net product sales were and$12.1 million , respectively, compared to$43.5 million and$11.0 million , respectively, for the same periods in 2020. La Jolla acquired Tetraphase, which commercialized XERAVA, on$33.4 million July 28, 2020 . Net product sales for the twelve months endedDecember 31, 2020 exclude XERAVA for the period prior toJuly 28, 2020 .-
GIAPREZA
U.S. Net Product Sales: For the three months endedDecember 31, 2021 , GIAPREZAU.S. net product sales were , up$9.2 million 3% from the three months endedSeptember 30, 2021 and up6% from the three months endedDecember 31, 2020 . For the twelve months endedDecember 31, 2021 , GIAPREZAU.S. net product sales were , up$33.4 million 14% from the same period in 2020. -
XERAVA
U.S. Net Product Sales: For the three months endedDecember 31, 2021 , XERAVAU.S. net product sales were , consistent with the three months ended$2.9 million September 30, 2021 and up26% from the three months endedDecember 31, 2020 . For the twelve months endedDecember 31, 2021 , XERAVAU.S. net product sales were , up$10.1 million 23% from the same period in 2020, including the period prior to the acquisition of Tetraphase.
-
GIAPREZA
-
Fourth Consecutive Quarter of Positive Net Cash Provided by Operating Activities: La Jolla had positive net cash provided by operating activities for the fourth consecutive quarter. La Jolla’s net cash provided by (used for) operating activities for the three and twelve months endedDecember 31, 2021 was and$3.1 million , respectively, compared to$28.2 million and$(7.2) million , respectively, for the same periods in 2020.$(37.6) million
“We are pleased to report that La Jolla had record net product sales for the three and twelve months ended
Financial Results
For the three and twelve months ended
La Jolla’s net income (loss) for the three and twelve months ended
As of
-
Upfront net receipts in connection with out-license agreements were zero and
for the three and twelve months ended$18.4 million December 31, 2021 , respectively, and zero for the same periods in 2020. -
Upfront net receipts in connection with commercial supply agreements were zero and
for the three and twelve months ended$6.8 million December 31, 2021 , respectively, and zero for the same periods in 2020. -
Payments related to reductions in headcount were zero and
for the three and twelve months ended$1.6 million December 31, 2021 , respectively, and and$1.6 million , respectively, for the same periods in 2020.$9.5 million -
Payments related to transaction costs associated with the Tetraphase acquisition were zero for the three and twelve months ended
December 31, 2021 , and zero and , respectively, for the same periods in 2020.$0.9 million
About GIAPREZA
GIAPREZA® (angiotensin II) injection is approved by the
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
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
About XERAVA
XERAVA® (eravacycline) for injection is approved by the
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 ≥
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
About
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
Consolidated Balance Sheets (in thousands, except par value and share amounts) |
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2021 |
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2020 |
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ASSETS |
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Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
46,668 |
|
|
$ |
21,221 |
|
Accounts receivable, net |
|
|
8,610 |
|
|
|
5,834 |
|
Inventory, net |
|
|
6,281 |
|
|
|
6,013 |
|
Prepaid expenses and other current assets |
|
|
5,756 |
|
|
|
3,388 |
|
Total current assets |
|
|
67,315 |
|
|
|
36,456 |
|
|
|
|
20,123 |
|
|
|
20,123 |
|
Intangible assets, net |
|
|
13,321 |
|
|
|
14,873 |
|
Right-of-use lease assets |
|
|
318 |
|
|
|
536 |
|
Property and equipment, net |
|
|
113 |
|
|
|
215 |
|
Restricted cash |
|
|
40 |
|
|
|
40 |
|
Total assets |
|
$ |
101,230 |
|
|
$ |
72,243 |
|
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|
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LIABILITIES AND STOCKHOLDERS’ DEFICIT |
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Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,278 |
|
|
$ |
2,762 |
|
Accrued expenses |
|
|
4,866 |
|
|
|
5,617 |
|
Accrued interest expense on deferred royalty obligation, current portion |
|
|
5,163 |
|
|
|
3,567 |
|
Deferred revenue |
|
|
2,849 |
|
|
|
188 |
|
Paycheck Protection Program loan, current portion |
|
|
2,325 |
|
|
|
- |
|
Lease liabilities, current portion |
|
|
154 |
|
|
|
204 |
|
Total current liabilities |
|
|
17,635 |
|
|
|
12,338 |
|
Deferred royalty obligation, net |
|
|
124,503 |
|
|
|
124,437 |
|
Accrued interest expense on deferred royalty obligation, less current portion |
|
|
24,590 |
|
|
|
19,111 |
|
Lease liabilities, less current portion |
|
|
164 |
|
|
|
332 |
|
Other noncurrent liabilities |
|
|
1,076 |
|
|
|
4,112 |
|
Total liabilities |
|
|
167,968 |
|
|
|
160,330 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
Stockholders’ deficit: |
|
|
|
|
|
|
|
|
Common Stock, |
|
|
3 |
|
|
|
3 |
|
Series C-12 Convertible Preferred Stock, |
|
|
3,906 |
|
|
|
3,906 |
|
Additional paid-in capital |
|
|
986,445 |
|
|
|
984,756 |
|
Accumulated deficit |
|
|
(1,057,092 |
) |
|
|
(1,076,752 |
) |
Total stockholders’ deficit |
|
|
(66,738 |
) |
|
|
(88,087 |
) |
Total liabilities and stockholders’ deficit |
|
$ |
101,230 |
|
|
$ |
72,243 |
|
Consolidated Statements of Operations (in thousands, except per share amounts) |
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Year Ended |
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2021 |
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2020 |
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Revenue |
|
|
|
|
|
|
|
|
Net product sales |
|
$ |
43,532 |
|
|
$ |
33,419 |
|
License and other revenue |
|
|
32,188 |
|
|
|
- |
|
Total revenue |
|
|
75,720 |
|
|
|
33,419 |
|
Operating expenses |
|
|
|
|
|
|
|
|
Cost of product sales |
|
|
8,976 |
|
|
|
7,819 |
|
Cost of license and other revenue |
|
|
4,513 |
|
|
|
- |
|
Selling, general and administrative |
|
|
35,386 |
|
|
|
38,428 |
|
Research and development |
|
|
5,014 |
|
|
|
23,010 |
|
Total operating expenses |
|
|
53,889 |
|
|
|
69,257 |
|
Income (loss) from operations |
|
|
21,831 |
|
|
|
(35,838 |
) |
Other (expense) income |
|
|
|
|
|
|
|
|
Interest expense |
|
|
(10,458 |
) |
|
|
(10,051 |
) |
Interest income |
|
|
7 |
|
|
|
235 |
|
Other income—related party |
|
|
7,596 |
|
|
|
6,279 |
|
Other income (expense) |
|
|
733 |
|
|
|
(46 |
) |
Total other (expense) income, net |
|
|
(2,122 |
) |
|
|
(3,583 |
) |
Income (loss) before income taxes |
|
|
19,709 |
|
|
|
(39,421 |
) |
Provision for income taxes |
|
|
49 |
|
|
|
- |
|
Net income (loss) |
|
$ |
19,660 |
|
|
$ |
(39,421 |
) |
Earnings (loss) per share |
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.72 |
|
|
$ |
(1.44 |
) |
Diluted |
|
$ |
0.58 |
|
|
$ |
(1.44 |
) |
Shares used in computing earnings (loss) per share |
|
|
|
|
|
|
|
|
Basic |
|
|
27,436 |
|
|
|
27,329 |
|
Diluted |
34,179 |
27,329 |
Consolidated Statements of Cash Flows (in thousands) |
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Year Ended |
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2021 |
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2020 |
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Operating activities |
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
19,660 |
|
|
$ |
(39,421 |
) |
Adjustments to reconcile net income (loss) to net cash provided by (used for) operating activities: |
|
|
|
|
|
|
|
|
Non-cash interest expense |
|
|
7,141 |
|
|
|
6,379 |
|
Share-based compensation expense |
|
|
4,477 |
|
|
|
6,207 |
|
Amortization of intangible assets |
|
|
1,552 |
|
|
|
647 |
|
Amortization of right-of-use lease assets |
|
|
218 |
|
|
|
1,249 |
|
Depreciation expense |
|
|
111 |
|
|
|
2,188 |
|
Inventory fair value step-up adjustment included in cost of product sales |
|
|
850 |
|
|
|
2,458 |
|
Gain on change in fair value of contingent value rights |
|
|
(734 |
) |
|
|
(800 |
) |
Loss on short-term investments |
|
|
- |
|
|
|
502 |
|
Loss on disposal of property and equipment, net of gain on lease termination |
|
|
- |
|
|
|
10 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable, net |
|
|
(2,776 |
) |
|
|
(1,687 |
) |
Inventory, net |
|
|
(1,118 |
) |
|
|
(1,493 |
) |
Prepaid expenses and other current assets |
|
|
(2,368 |
) |
|
|
2,297 |
|
Accounts payable |
|
|
(484 |
) |
|
|
(2,815 |
) |
Accrued expenses |
|
|
(728 |
) |
|
|
(11,423 |
) |
Deferred revenue |
|
|
2,661 |
|
|
|
188 |
|
Lease liabilities |
|
|
(218 |
) |
|
|
(2,126 |
) |
Net cash provided by (used for) operating activities |
|
|
28,244 |
|
|
|
(37,640 |
) |
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 |
|
|
|
|
|
|
|
|
Purchases of common stock under Stock Repurchase Plan |
|
|
(3,380 |
) |
|
|
- |
|
Net proceeds from issuance of common stock under ESPP |
|
|
436 |
|
|
|
512 |
|
Net proceeds from issuance of common stock under 2013 Equity Plan |
|
|
156 |
|
|
|
605 |
|
Net cash (used for) provided by financing activities |
|
|
(2,788 |
) |
|
|
1,117 |
|
Net increase (decrease) in cash, cash equivalents and restricted cash |
|
|
25,447 |
|
|
|
(67,468 |
) |
Cash, cash equivalents and restricted cash, beginning of period |
|
|
21,261 |
|
|
|
88,729 |
|
Cash, cash equivalents and restricted cash, end of period |
|
$ |
46,708 |
|
|
$ |
21,261 |
|
Supplemental disclosure of non-cash investing and financing activities |
|
|
|
|
|
|
|
|
Initial recognition of right-of-use lease asset |
|
$ |
- |
|
|
$ |
536 |
|
Reconciliation of cash, cash equivalents and restricted cash to the consolidated balance sheets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
46,668 |
|
|
$ |
21,221 |
|
Restricted cash |
|
|
40 |
|
|
|
40 |
|
Total cash, cash equivalents and restricted cash |
|
$ |
46,708 |
|
|
$ |
21,261 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20220309005270/en/
Chief Financial Officer
(617) 715-3598
mhearne@ljpc.com
Source:
FAQ
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