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

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




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

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

 

 

Contacts

La Jolla Pharmaceutical Company Contact
Michael Hearne

Chief Financial Officer

La Jolla Pharmaceutical Company

(617) 715-3598

mhearne@ljpc.com