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La Jolla Pharmaceutical Company Announces Financial Results for the Three and Nine Months Ended September 30, 2020

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La Jolla Pharmaceutical Company (NASDAQ:LJPC), which is dedicated to the development and 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, 2020.

On July 28, 2020, La Jolla completed its acquisition of Tetraphase Pharmaceuticals, Inc. (Tetraphase), a biopharmaceutical company focused on commercializing its novel tetracycline, XERAVATM (eravacycline), to treat serious and life-threatening infections, for $43 million in upfront cash plus potential future cash payments of up to $16 million. Financial results for periods ending September 30, 2020 and beyond include Tetraphase's financial results subsequent to the acquisition closing date of July 28, 2020.

For the three months ended September 30, 2020, GIAPREZA U.S. net sales were $7.2 million, up 24% from the three months ended June 30, 2020 and up 26% from the three months ended September 30, 2019. For the nine months ended September 30, 2020, GIAPREZA U.S. net sales were $20.6 million, up 30% from the same period in 2019.

Subsequent to July 28, 2020 and through September 30, 2020, XERAVA U.S. net sales were $1.9 million. For the three months ended September 30, 2020, XERAVA U.S. net sales were $2.7 million, up 80% from the three months ended June 30, 2020 and up 170% from the three months ended September 30, 2019. For the nine months ended September 30, 2020, XERAVA U.S. net sales were $5.9 million, up 181% from the same period in 2019.

La Jolla's net loss for the three and nine months ended September 30, 2020 was $11.8 million and $35.9 million, or $0.43 and $1.32 per share, respectively, compared to $29.2 million and $91.3 million, or $1.08 per share and $3.37 per share, respectively, for the same periods in 2019.

As of September 30, 2020, La Jolla had $27.8 million of cash and cash equivalents. Net cash used in operating activities for the three and nine months ended September 30, 2020 was $9.8 million and $30.4 million, respectively, down 48% and 55%, respectively, from the same periods in 2019. Net cash used in operating activities for the three and nine months ended September 30, 2020, excluding cash expenditures related to reductions in headcount and transaction costs associated with the Tetraphase acquisition, was $5.6 million and $21.6 million, respectively, down 70% and 67%, respectively, from the same periods in 2019. Cash expenditures related to reductions in headcount were $3.3 million and $7.9 million for the three and nine months ended September 30, 2020, respectively, and zero and $2.3 million, respectively, for the same periods in 2019. Cash expenditures related to transaction costs associated with the Tetraphase acquisition were $0.9 million for the three and nine months ended September 30, 2020.

"The third quarter was productive for La Jolla as we completed the integration of Tetraphase, increased net sales of both products compared to the prior quarter and increased our presence in the hospital," said Larry Edwards, President and Chief Executive Officer of La Jolla. "By leveraging the stronger platform that the combined company is providing, we are increasing patient and physician access to our two innovative therapies for life-threatening diseases."

About GIAPREZA

GIAPREZATM (angiotensin II) for 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 http://www.giapreza.com. The European Summary of Product Characteristics is available on the EMA website: 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.

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

XERAVATM (eravacycline) for injection is a novel fluorocycline of the tetracycline class of antibacterials that is approved by the U.S. Food and Drug Administration (FDA) 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. XERAVA is marketed in the U.S. by Tetraphase Pharmaceuticals, Inc., a wholly owned subsidiary of La Jolla.

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 development and commercialization of innovative therapies that improve outcomes in patients suffering from life-threatening diseases. GIAPREZA™ (angiotensin II) is approved by the U.S. FDA as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. XERAVA™ (eravacycline) is approved by the U.S. FDA for the treatment of complicated intra-abdominal infections. 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 XERAVATM (eravacycline) sales; whether La Jolla will realize the benefits from the acquisition of Tetraphase Pharmaceuticals, Inc.; regulatory actions relating to La Jolla's products by the U.S. FDA, European Commission and/or other regulatory authorities; the expected future cash flows of La Jolla; whether La Jolla can become cash flow positive and the timing for achieving this; 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,

 

 

 

2020

 

 

 

 

2019

 

 

 

(Unaudited)

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

27,760

 

 

 

 

$

87,820

 

Accounts receivable, net

 

 

3,929

 

 

 

 

 

2,960

 

Inventory, net

 

 

7,274

 

 

 

 

 

2,211

 

Prepaid expenses and other current assets

 

 

3,240

 

 

 

 

 

4,467

 

Total current assets

 

 

42,203

 

 

 

 

 

97,458

 

Property and equipment, net

 

 

284

 

 

 

 

 

18,389

 

Right-of-use lease assets

 

 

2,150

 

 

 

 

 

15,491

 

Restricted cash

 

 

699

 

 

 

 

 

909

 

Intangible assets, net

 

 

15,261

 

 

 

 

 

-

 

Goodwill

 

 

20,123

 

 

 

 

 

-

 

Total assets

 

$

80,720

 

 

 

 

$

132,247

 

 

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND SHAREHOLDERS' DEFICIT

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

 

 

Accounts payable

 

$

3,928

 

 

 

 

$

4,177

 

Accrued expenses

 

 

7,683

 

 

 

 

 

9,312

 

Accrued payroll and related expenses

 

 

6,164

 

 

 

 

 

8,332

 

Lease liabilities, current portion

 

 

985

 

 

 

 

 

2,766

 

Total current liabilities

 

 

18,760

 

 

 

 

 

24,587

 

Lease liabilities, less current portion

 

 

1,249

 

 

 

 

 

26,481

 

Deferred royalty obligation, net

 

 

124,421

 

 

 

 

 

124,379

 

Other noncurrent liabilities

 

 

21,805

 

 

 

 

 

12,790

 

Total liabilities

 

$

166,235

 

 

 

 

$

188,237

 

Commitments and contingencies (Note 6)

 

 

 

 

 

 

 

 

 

 

Shareholders' deficit:

 

 

 

 

 

 

 

 

 

 

Common Stock, $0.0001 par value; 100,000,000 shares authorized, 27,378,048 and 27,195,469 shares issued and outstanding at September 30, 2020 and December 31, 2019, 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, 2020 and December 31, 2019; and liquidation preference of $3,906 at September 30, 2020 and December 31, 2019

 

 

3,906

 

 

 

 

 

3,906

 

Additional paid-in capital

 

 

983,850

 

 

 

 

 

977,432

 

Accumulated deficit

 

 

(1,073,274

)

 

 

 

 

(1,037,331

)

Total shareholders' deficit

 

 

(85,515

)

 

 

 

 

(55,990

)

Total liabilities and shareholders' deficit

 

$

80,720

 

 

 

 

$

132,247

 

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,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Revenue

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net product sales

 

$

9,072

 

 

$

5,706

 

 

$

22,468

 

 

$

15,804

 

Total revenue

 

 

9,072

 

 

 

5,706

 

 

 

22,468

 

 

 

15,804

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product sales

 

 

2,489

 

 

 

554

 

 

 

4,013

 

 

 

1,605

 

Research and development

 

 

3,617

 

 

 

21,182

 

 

 

21,581

 

 

 

64,469

 

Selling, general and administrative

 

 

12,493

 

 

 

10,782

 

 

 

29,322

 

 

 

34,425

 

Total operating expenses

 

 

18,599

 

 

 

32,518

 

 

 

54,916

 

 

 

100,499

 

Loss from operations

 

 

(9,527

)

 

 

(26,812

)

 

 

(32,448

)

 

 

(84,695

)

Other income (expense)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(2,526

)

 

 

(2,863

)

 

 

(7,402

)

 

 

(8,398

)

Interest income

 

 

12

 

 

 

501

 

 

 

234

 

 

 

1,818

 

Other income—related party

 

 

-

 

 

 

-

 

 

 

4,085

 

 

 

-

 

Other expense (expense)

 

 

281

 

 

 

-

 

 

 

(412

)

 

 

-

 

Total other income (expense), net

 

 

(2,233

)

 

 

(2,362

)

 

 

(3,495

)

 

 

(6,580

)

Net loss

 

$

(11,760

)

 

$

(29,174

)

 

$

(35,943

)

 

$

(91,275

)

Net loss per share, basic and diluted

 

$

(0.43

)

 

$

(1.08

)

 

$

(1.32

)

 

$

(3.37

)

Weighted-average common shares outstanding, basic and diluted

 

 

27,368

 

 

 

27,135

 

 

 

27,311

 

 

 

27,093

 

LA JOLLA PHARMACEUTICAL COMPANY

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(in thousands)

 

 

Nine Months Ended

 

 

 

September 30,

 

 

 

2020

 

 

2019

 

Operating activities

 

 

 

 

 

 

 

 

Net loss

 

$

(35,943

)

 

$

(91,275

)

Adjustments to reconcile net loss to net cash used for operating activities:

 

 

 

 

 

 

 

 

Share-based compensation expense

 

 

5,385

 

 

 

19,522

 

Depreciation expense

 

 

2,155

 

 

 

3,408

 

Inventory fair value step-up adjustment included in cost of product sales

 

 

1,186

 

 

 

-

 

Amortization of intangible assets

 

 

259

 

 

 

-

 

Amortization of right-of-use lease assets

 

 

1,091

 

 

 

969

 

Non-cash interest expense

 

 

5,339

 

 

 

6,971

 

Loss on short-term investments

 

 

502

 

 

 

-

 

Loss on disposal of property and equipment, net of gain on lease termination

 

 

59

 

 

 

15

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable, net

 

 

218

 

 

 

(36

)

Inventory, net

 

 

(1,482

)

 

 

110

 

Prepaid expenses and other current assets

 

 

2,445

 

 

 

328

 

Accounts payable

 

 

(1,649

)

 

 

(3,234

)

Accrued expenses

 

 

(5,786

)

 

 

(332

)

Accrued payroll and related expenses

 

 

(2,168

)

 

 

(2,391

)

Lease liabilities

 

 

(1,969

)

 

 

(1,873

)

Net cash used for operating activities

 

 

(30,358

)

 

 

(67,818

)

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

 

 

-

 

 

 

(679

)

Proceeds from the sale of short-term investments

 

 

2,497

 

 

 

-

 

Purchases of short-term investments

 

 

(2,999

)

 

 

-

 

Net cash used for investing activities

 

 

(30,945

)

 

 

(679

)

Financing activities

 

 

 

 

 

 

 

 

Net proceeds from issuance of common stock under 2013 Equity Plan

 

 

605

 

 

 

-

 

Net proceeds from issuance of common stock under ESPP

 

 

428

 

 

 

661

 

Net cash provided by financing activities

 

 

1,033

 

 

 

661

 

Net decrease in cash, cash equivalents and restricted cash

 

 

(60,270

)

 

 

(67,836

)

Cash, cash equivalents and restricted cash, beginning of period

 

 

88,729

 

 

 

173,513

 

Cash, cash equivalents and restricted cash, end of period

 

$

28,459

 

 

$

105,677

 

Supplemental disclosure of non-cash investing and financing activities

 

 

 

 

 

 

 

 

Conversion of Series F Convertible Preferred Stock into common stock

 

$

-

 

 

$

2,737

 

Cumulative-effect adjustment from adoption of ASU 2018-07

 

$

-

 

 

$

(160

)

Initial recognition of right-of-use lease asset

 

$

-

 

 

$

16,798

 

Reconciliation of cash, cash equivalents and restricted cash to the condensed consolidated balance sheets

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

27,760

 

 

$

104,768

 

Restricted cash

 

 

699

 

 

 

909

 

Total cash, cash equivalents and restricted cash

 

$

28,459

 

 

$

105,677

 

 

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