La Jolla Pharmaceutical Firm Declares Monetary Outcomes for the Three and Twelve Months Ended December 31, 2020 and Highlights Company Progress | Enterprise

SAN DIEGO–(BUSINESS WIRE)–Mar 8, 2021–

La Jolla Pharmaceutical Firm (Nasdaq: LJPC), which is devoted to the event and commercialization of revolutionary therapies that enhance outcomes in sufferers affected by life-threatening ailments, in the present day introduced monetary outcomes for the three and twelve months ended December 31, 2021 and highlighted company progress.

Company Progress

  • Unique Licensing Settlement for GIAPREZA™ (Angiotensin II) and XERAVA™ (Eravacycline) in Europe: In January 2021, La Jolla Pharmaceutical Firm introduced that it and sure of its wholly owned subsidiaries (collectively, La Jolla) entered into an unique licensing settlement with PAION AG and its wholly owned subsidiary (collectively, PAION) to commercialize GIAPREZA and XERAVA within the European Financial Space, the UK and Switzerland (the Territories). Underneath the phrases of the unique licensing settlement, La Jolla is entitled to obtain: (i) an upfront money cost of $22.5 million; (ii) potential business milestone funds of as much as $109.5 million; and (iii) double-digit tiered royalty funds primarily based on web gross sales of GIAPREZA and XERAVA.
  • Acquisition of Tetraphase Prescription drugs, Inc. (Tetraphase): In July 2020, La Jolla accomplished its acquisition of Tetraphase, a biopharmaceutical firm targeted on commercializing its novel tetracycline, XERAVA, to deal with critical and life-threatening infections. Monetary outcomes for intervals ending December 31, 2020 and past embody Tetraphase’s monetary outcomes subsequent to the acquisition cut-off date of July 28, 2020.
  • Web Gross sales: For the three and twelve months ended December 31, 2020, web gross sales had been $11.0 million and $33.4 million, respectively, in comparison with $7.3 million and $23.1 million, respectively, for a similar intervals in 2019.
    • GIAPREZA Web Gross sales: For the three and twelve months ended December 31, 2020, GIAPREZA U.S. web gross sales had been $8.7 million and $29.3 million, respectively, up 19% and 27%, respectively, from the identical intervals in 2019.
    • XERAVA Web Gross sales: Subsequent to July 28, 2020 and thru December 31, 2020, XERAVA U.S. web gross sales had been $4.2 million. For the three and twelve months ended December 31, 2020, together with the interval previous to the acquisition of Tetraphase, XERAVA U.S. web gross sales had been $2.3 million and $8.2 million, respectively, up 53% and 128%, respectively, from the identical intervals in 2019.

“2020 was a productive 12 months for La Jolla as we accomplished the mixing of Tetraphase, elevated web gross sales of each merchandise in comparison with the prior 12 months and diminished our working prices,” mentioned Larry Edwards, President and Chief Govt Officer of La Jolla. “Our settlement with PAION positions us nicely to serve the wants of sufferers affected by life-threatening ailments in each the U.S. and Europe. As we enter 2021, our focus shall be on persevering with to develop web gross sales of each GIAPREZA and XERAVA whereas persevering with to handle working prices.”

Monetary Outcomes

For the three and twelve months ended December 31, 2020, web gross sales had been $11.0 million and $33.4 million, respectively, in comparison with $7.3 million and $23.1 million, respectively, for a similar intervals in 2019.

La Jolla’s web loss for the three and twelve months ended December 31, 2020 was $3.5 million and $39.4 million, or $0.13 and $1.44 per share, respectively, in comparison with $25.2 million and $116.5 million, or $0.93 per share and $4.30 per share, respectively, for a similar intervals in 2019.

As of December 31, 2020, La Jolla had $21.2 million of money and money equivalents. On a professional forma foundation, adjusting for $18.9 million of upfront web proceeds from its licensing settlement with PAION, web of the quantities due underneath the George Washington College and Harvard College license agreements, La Jolla had money and money equivalents of $40.1 million.

Web money used for working actions for the three and twelve months ended December 31, 2020 was $7.3 million and $37.6 million, respectively, down 57% and 56%, respectively, from the identical intervals in 2019. Web money used for working actions for the three and twelve months ended December 31, 2020, excluding money expenditures associated to reductions in headcount and transaction prices related to the Tetraphase acquisition, was $5.7 million and $27.2 million, respectively, down 65% and 67%, respectively, from the identical intervals in 2019. Money expenditures associated to reductions in headcount had been $1.6 million and $9.5 million for the three and twelve months ended December 31, 2020, respectively, and $0.9 million and $3.2 million, respectively, for a similar intervals in 2019. Money expenditures associated to transaction prices related to the Tetraphase acquisition had been zero and $0.9 million for the three and twelve months ended December 31, 2020, respectively.

About GIAPREZA

GIAPREZA™ (angiotensin II) injection is authorised by the U.S. Meals and Drug Administration (FDA) as a vasoconstrictor indicated to extend blood strain in adults with septic or different distributive shock. GIAPREZA is authorised by the European Fee (EC) for the remedy of refractory hypotension in adults with septic or different distributive shock who stay hypotensive regardless of satisfactory quantity restitution and software of catecholamines and different out there vasopressor therapies. GIAPREZA mimics the physique’s endogenous angiotensin II peptide, which is central to the renin-angiotensin-aldosterone system, which in flip regulates blood strain. Prescribing info for GIAPREZA is accessible at http://www.giapreza.com. The European Abstract of Product Traits is accessible on the EMA web site: www.ema.europa.eu/en/medicines/human/EPAR/giapreza. GIAPREZA is marketed within the U.S. by La Jolla Pharmaceutical Firm on behalf of La Jolla Pharma, LLC, its wholly owned subsidiary, and shall be marketed in Europe by PAION AG on behalf of La Jolla Pharma, LLC.

GIAPREZA Necessary Security Data

Contraindications

None.

Warnings and Precautions

There’s a potential for venous and arterial thrombotic and thromboembolic occasions in sufferers who obtain GIAPREZA. Use concurrent venous thromboembolism (VTE) prophylaxis.

Hostile Reactions

The commonest opposed reactions that had been reported in larger than 10% of GIAPREZA-treated sufferers had been thromboembolic occasions.

Drug Interactions

Angiotensin changing enzyme (ACE) inhibitors could enhance response to GIAPREZA. Angiotensin II receptor blockers (ARBs) could cut back response to GIAPREZA.

You might be inspired to report detrimental negative effects of prescribed drugs to the FDA. Go to www.fda.gov/medwatch or name 1-800-FDA-1088.

For added info, please see Full Prescribing Data for america and the Abstract of Product Traits for the European Union.

About XERAVA

XERAVA™ (eravacycline) for injection is authorised by the U.S. Meals and Drug Administration (FDA) as a tetracycline class antibacterial indicated for the remedy of difficult intra-abdominal infections (cIAI) in sufferers 18 years of age and older. XERAVA is authorised by the European Fee (EC) for the remedy of cIAI in adults. Prescribing info for XERAVA is accessible at www.xerava.com. XERAVA is marketed within the U.S. by Tetraphase Prescription drugs, Inc., a completely owned subsidiary of La Jolla, and shall be marketed in Europe by PAION AG on behalf of Tetraphase Prescription drugs, Inc.

XERAVA Necessary Security Data

XERAVA is a tetracycline class antibacterial indicated for the remedy of difficult intra-abdominal infections in sufferers 18 years of age and older.

XERAVA will not be indicated for the remedy of difficult urinary tract infections.

To scale back the event of drug-resistant micro organism and keep the effectiveness of XERAVA and different antibacterial medicine, XERAVA must be used solely to deal with or forestall infections which are confirmed or strongly suspected to be brought on by inclined micro organism.

XERAVA is contraindicated to be used in sufferers with identified hypersensitivity to eravacycline, tetracycline-class antibacterial medicine or to any of the excipients. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA.

The usage of XERAVA throughout tooth growth (final half of being pregnant, infancy and childhood to the age of eight years) could trigger everlasting discoloration of the tooth (yellow-gray-brown) and enamel hypoplasia.

The usage of XERAVA throughout the second and third trimester of being pregnant, infancy and childhood as much as the age of eight years could trigger reversible inhibition of bone progress.

Clostridium difficile related diarrhea (CDAD) has been reported with use of almost all antibacterial brokers and will vary in severity from delicate diarrhea to deadly colitis.

The commonest opposed reactions noticed in scientific trials (incidence ≥ 3%) had been infusion website reactions, nausea and vomiting.

XERAVA is structurally just like tetracycline-class antibacterial medicine and will have related opposed reactions. Hostile reactions together with photosensitivity, pseudotumor cerebri and anti-anabolic motion, which has led to elevated blood urea nitrogen, azotemia, acidosis, hyperphosphatemia, pancreatitis and irregular liver operate assessments, have been reported for different tetracycline-class antibacterial medicine, and will happen with XERAVA. Discontinue XERAVA if any of those opposed reactions are suspected.

You might be inspired to report detrimental negative effects of prescribed drugs to the FDA. Go to www.fda.gov/medwatch or name 1-800-FDA-1088.

For added info, please see Full Prescribing Data for america.

About La Jolla Pharmaceutical Firm

La Jolla Pharmaceutical Firm is devoted to the event and commercialization of revolutionary therapies that enhance outcomes in sufferers affected by life-threatening ailments. GIAPREZA™ (angiotensin II) is authorised by the U.S. FDA as a vasoconstrictor indicated to extend blood strain in adults with septic or different distributive shock. XERAVA™ (eravacycline) is authorised by the U.S. FDA for the remedy of difficult intra-abdominal infections. For extra info, please go to www.ljpc.com.

Ahead-looking Statements

This press launch incorporates “forward-looking statements” as outlined by the Non-public Securities Litigation Reform Act of 1995. We warning traders that forward-looking statements are primarily based on administration’s expectations and assumptions as of the date of this press launch and contain substantial dangers and uncertainties that would trigger the precise outcomes to vary materially from what we at present anticipate. These dangers and uncertainties embody, however usually are not restricted to, these related to: GIAPREZA™ (angiotensin II) and XERAVA™ (eravacycline) gross sales; whether or not La Jolla will notice the advantages from the acquisition of Tetraphase Prescription drugs, Inc.; regulatory actions regarding La Jolla’s merchandise by the U.S. FDA, European Fee and/or different regulatory authorities; anticipated future money flows of La Jolla, together with milestone and/or royalty funds ensuing from La Jolla’s unique license settlement with PAION AG; and different dangers and uncertainties recognized in our filings with the U.S. Securities and Change Fee. Ahead-looking statements on this press launch apply solely as of the date made, and we undertake no obligation to replace or revise any forward-looking statements to mirror subsequent occasions or circumstances.

LA JOLLA PHARMACEUTICAL COMPANY

Condensed Consolidated Steadiness Sheets

(in hundreds, besides par worth and share quantities)

 
December 31, December 31,
2020 2019
ASSETS
Present property:
Money and money equivalents $ 21,221 $ 87,820
Accounts receivable, web 5,834 2,960
Stock, web 6,013 2,211
Pay as you go bills and different present property 3,388 4,467
Complete present property 36,456 97,458
Goodwill 20,123
Intangible property, web 14,873
Proper-of-use lease property 536 15,491
Property and gear, web 215 18,389
Restricted money 40 909
Complete property $ 72,243 $ 132,247
LIABILITIES AND SHAREHOLDERS’ DEFICIT
Present liabilities:
Accounts payable $ 2,762 $ 4,177
Accrued bills 6,494 9,312
Accrued payroll and associated bills 2,878 8,332
Lease liabilities, present portion 204 2,766
Complete present liabilities 12,338 24,587
Deferred royalty obligation, web 124,437 124,379
Accrued curiosity expense on deferred royalty obligation, much less present portion 19,111 12,790
Lease liabilities, much less present portion 332 26,481
Different noncurrent liabilities 4,112
Complete liabilities $ 160,330 $ 188,237
Commitments and contingencies (Word 6)
Shareholders’ deficit:
Frequent Inventory, $0.0001 par worth; 100,000,000 shares licensed, 27,402,648 and 27,195,469 shares issued and excellent at December 31, 2020 and December 31, 2019, respectively 3 3
Collection C-1 2 Convertible Most popular Inventory, $0.0001 par worth; 11,000 shares licensed, 3,906 shares issued and excellent at December 31, 2020 and December 31, 2019; and liquidation desire of $3,906 at December 31, 2020 and December 31, 2019 3,906 3,906
Further paid-in capital 984,756 977,432
Gathered deficit (1,076,752 ) (1,037,331 )
Complete shareholders’ deficit (88,087 ) (55,990 )
Complete liabilities and shareholders’ deficit $ 72,243 $ 132,247
LA JOLLA PHARMACEUTICAL COMPANY

Condensed Consolidated Statements of Operations

(in hundreds, besides per share quantities)

 
Yr Ended
December 31,
2020 2019
Income
Web product gross sales $ 33,419 $ 23,054
Complete income 33,419 23,054
Working bills
Value of product gross sales 7,819 2,392
Promoting, basic and administrative 38,428 45,134
Analysis and growth 23,010 85,329
Complete working bills 69,257 132,855
Loss from operations (35,838 ) (109,801 )
Different earnings (expense)
Curiosity expense (10,051 ) (10,774 )
Curiosity earnings 235 2,128
Different earnings—associated get together 6,279 1,939
Different earnings (expense) (46 )
Complete different earnings (expense), web (3,583 ) (6,707 )
Web loss $ (39,421 ) $ (116,508 )
Web loss per share, fundamental and diluted $ (1.44 ) $ (4.30 )
Weighted-average frequent shares excellent, fundamental and diluted 27,329 27,112
LA JOLLA PHARMACEUTICAL COMPANY

Condensed Consolidated Statements of Money Flows

(Unaudited)

(in hundreds)

 
Yr Ended
December 31,
2020 2019
Working actions
Web loss $ (39,421 ) $ (116,508 )
Changes to reconcile web loss to web money used for working actions:
Share-based compensation expense 6,207 23,733
Depreciation expense 2,188 4,552
Non-cash curiosity expense 6,379 8,775
Stock truthful worth step-up adjustment included in value of product gross sales 2,458
Amortization of intangible property 647
Change in truthful worth of contingent worth rights (800 )
Amortization of right-of-use lease property 1,249 1,307
Loss on short-term investments 502
Loss on disposal of property and gear, web of achieve on lease termination 10 24
Modifications in working property and liabilities:
Accounts receivable, web (1,687 ) (1,579 )
Stock, web (1,493 ) (191 )
Pay as you go bills and different present property 2,297 644
Accounts payable (2,815 ) (4,395 )
Accrued bills (5,781 ) 395
Accrued payroll and associated bills (5,454 ) 823
Lease liabilities (2,126 ) (2,530 )
Web money used for working actions (37,640 ) (84,950 )
Investing actions
Acquisition of Tetraphase, web of money, money equivalents and restricted money acquired (33,513 )
Purchases of short-term investments (2,999 )
Purchases of property and gear (698 )
Proceeds from the sale of property and gear 3,070
Proceeds from the sale of short-term investments 2,497
Web money used for investing actions (30,945 ) (698 )
Financing actions
Web proceeds from issuance of frequent inventory underneath 2013 Fairness Plan 605 31
Web proceeds from issuance of frequent inventory underneath ESPP 512 833
Web money offered by financing actions 1,117 864
Web lower in money, money equivalents and restricted money (67,468 ) (84,784 )
Money, money equivalents and restricted money, starting of interval 88,729 173,513
Money, money equivalents and restricted money, finish of interval $ 21,261 $ 88,729
Supplemental disclosure of non-cash investing and financing actions
Preliminary recognition of right-of-use lease asset $ 536 $ 16,798
Conversion of Collection F Convertible Most popular Inventory into frequent inventory $ $ 2,737
Cumulative-effect adjustment from adoption of ASU 2018-07 $ $ (160 )
Reconciliation of money, money equivalents and restricted money to the consolidated steadiness sheets
Money and money equivalents $ 21,221 $ 87,820
Restricted money 40 909
Complete money, money equivalents and restricted money $ 21,261 $ 88,729

View supply model on businesswire.com:https://www.businesswire.com/information/house/20210308005193/en/

CONTACT: Michael Hearne

Chief Monetary Officer

La Jolla Pharmaceutical Firm

(858) 333-5769

[email protected]

KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA

INDUSTRY KEYWORD: BIOTECHNOLOGY PHARMACEUTICAL HEALTH

SOURCE: La Jolla Pharmaceutical Firm

Copyright Enterprise Wire 2021.

PUB: 03/08/2021 08:55 AM/DISC: 03/08/2021 08:55 AM

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