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 six
months ended June 30, 2020 and highlighted recent corporate
progress.
Recent Corporate Progress
- Acquisition of Tetraphase Pharmaceuticals,
Inc.: On July 28, 2020, La Jolla completed its acquisition
of Tetraphase Pharmaceuticals, Inc., a biopharmaceutical company
focused on commercializing its novel tetracycline,
XERAVA™ (eravacycline), to treat serious and life-threatening
infections, for $43 million in upfront cash plus potential future
cash payments of up to $16 million. For the three and six months
ended June 30, 2020, U.S. net sales of XERAVA, which was launched
in October 2018, were $1.5 million and $3.2 million, up 88% and
191%, respectively, from the same periods in 2019. Complete
financial results of Tetraphase for the six months ended June 30,
2020 will be included in an amended Form 8-K to be filed by La
Jolla on or before October 13, 2020. Financial results for periods
ending September 30, 2020 and beyond will include Tetraphase’s
financial results subsequent to the acquisition closing date of
July 28, 2020.
- Appointment of Larry Edwards as President and Chief
Executive Officer: Effective July 28, 2020, La Jolla’s
Board of Directors appointed Larry Edwards as President and Chief
Executive Officer of La Jolla.
“With two, FDA-approved, innovative therapies for
life-threatening diseases, La Jolla is well-positioned to help
patients in need,” said Larry Edwards, President and Chief
Executive Officer of La Jolla. “By leveraging the stronger platform
that the combined company will provide, we look forward to
increasing patient access to these important medicines.”
Financial Results
For the three and six months ended June 30, 2020, U.S. net
sales of GIAPREZA were $5.8 million and $13.4 million, up 2% and
33%, respectively, from the same periods in 2019.
La Jolla’s net loss for the three and six months ended
June 30, 2020 was $15.6 million and $24.2 million, or $0.57
and $0.89 per share, respectively, compared to $30.4 million and
$62.1 million, or $1.12 per share and $2.29 per share,
respectively, for the same periods in 2019.
As of June 30, 2020, La Jolla had $71.4 million of cash and
short-term investments, compared to $87.8 million as of
December 31, 2019. Net cash used in operating activities for
the three and six months ended June 30, 2020 was $8.4 million
and $20.6 million, respectively, down 49% and 58%, respectively,
from the same periods in 2019.
About GIAPREZA
GIAPREZA™ (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
XERAVA™ (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 XERAVA™ (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; cash used in operating activities and our
capital requirements; 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)
| |
June 30, 2020 |
|
December 31, 2019 |
| |
(Unaudited) |
|
|
| ASSETS |
|
|
|
| Current assets: |
|
|
|
|
Cash |
$ |
68,353 |
|
|
$ |
87,820 |
|
|
Short-term investments |
3,062 |
|
|
— |
|
|
Accounts receivable, net |
1,843 |
|
|
2,960 |
|
|
Inventory, net |
3,120 |
|
|
2,211 |
|
|
Prepaid expenses and other current assets |
2,792 |
|
|
4,467 |
|
|
Total current assets |
79,170 |
|
|
97,458 |
|
| Property and equipment,
net |
12,827 |
|
|
18,389 |
|
| Right-of-use lease asset |
14,792 |
|
|
15,491 |
|
| Restricted cash |
606 |
|
|
909 |
|
| Total
assets |
$ |
107,395 |
|
|
$ |
132,247 |
|
| |
|
|
|
| LIABILITIES AND
SHAREHOLDERS’ DEFICIT |
|
|
|
| Current liabilities: |
|
|
|
|
Accounts payable |
$ |
2,481 |
|
|
$ |
4,177 |
|
|
Accrued expenses |
6,772 |
|
|
9,312 |
|
|
Accrued payroll and related expenses |
5,741 |
|
|
8,332 |
|
|
Lease liability, current portion |
2,890 |
|
|
2,766 |
|
|
Total current liabilities |
17,884 |
|
|
24,587 |
|
| Lease liability, less current
portion |
25,000 |
|
|
26,481 |
|
| Deferred royalty obligation,
net |
124,406 |
|
|
124,379 |
|
| Other noncurrent
liabilities |
15,317 |
|
|
12,790 |
|
| Total
liabilities |
182,607 |
|
|
188,237 |
|
| Commitments and contingencies
(Note 6) |
|
|
|
| Shareholders’ deficit: |
|
|
|
|
Common Stock, $0.0001 par value; 100,000,000 shares
authorized,27,358,611 and 27,195,469 shares issued and outstanding
at June 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 June 30,
2020 and December 31, 2019; and liquidation preference of
$3,906 at June 30, 2020 and December 31, 2019 |
3,906 |
|
|
3,906 |
|
|
Additional paid-in capital |
982,393 |
|
|
977,432 |
|
|
Accumulated deficit |
(1,061,514 |
) |
|
(1,037,331 |
) |
|
Total shareholders’ deficit |
(75,212 |
) |
|
(55,990 |
) |
| Total liabilities and
shareholders’ deficit |
$ |
107,395 |
|
|
$ |
132,247 |
|
| |
|
|
|
|
|
|
|
LA JOLLA PHARMACEUTICAL
COMPANY
Condensed Consolidated Statements of
Operations(Unaudited)(in thousands,
except per share amounts)
| |
Three Months Ended June 30, |
|
Six Months
Ended June 30, |
| |
2020 |
|
2019 |
|
2020 |
|
2019 |
| Revenue |
|
|
|
|
|
|
|
|
Net product sales |
$ |
5,805 |
|
|
$ |
5,703 |
|
|
$ |
13,396 |
|
|
$ |
10,098 |
|
| Total revenue |
5,805 |
|
|
5,703 |
|
|
13,396 |
|
|
10,098 |
|
| Operating
expenses |
|
|
|
|
|
|
|
|
Cost of product sales |
808 |
|
|
551 |
|
|
1,524 |
|
|
1,051 |
|
|
Research and development |
8,781 |
|
|
22,043 |
|
|
17,964 |
|
|
43,287 |
|
|
Selling, general and administrative |
8,677 |
|
|
11,323 |
|
|
16,829 |
|
|
23,643 |
|
| Total operating expenses |
18,266 |
|
|
33,917 |
|
|
36,317 |
|
|
67,981 |
|
| Loss from operations |
(12,461 |
) |
|
(28,214 |
) |
|
(22,921 |
) |
|
(57,883 |
) |
| Other income
(expense) |
|
|
|
|
|
|
|
|
Interest expense |
(2,470 |
) |
|
(2,806 |
) |
|
(4,876 |
) |
|
(5,535 |
) |
|
Interest income |
32 |
|
|
604 |
|
|
222 |
|
|
1,317 |
|
|
Other income—related party |
— |
|
|
— |
|
|
4,085 |
|
|
— |
|
|
Other expense |
(693 |
) |
|
— |
|
|
(693 |
) |
|
— |
|
| Total other income (expense),
net |
(3,131 |
) |
|
(2,202 |
) |
|
(1,262 |
) |
|
(4,218 |
) |
| Net loss |
$ |
(15,592 |
) |
|
$ |
(30,416 |
) |
|
$ |
(24,183 |
) |
|
$ |
(62,101 |
) |
| Net loss per share,
basic and diluted |
$ |
(0.57 |
) |
|
$ |
(1.12 |
) |
|
$ |
(0.89 |
) |
|
$ |
(2.29 |
) |
| Weighted-average common shares
outstanding, basic and diluted |
27,326 |
|
|
27,108 |
|
|
27,282 |
|
|
27,071 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
LA JOLLA PHARMACEUTICAL
COMPANY
Condensed Consolidated Statements of Cash
Flows(Unaudited)
| |
Six Months Ended June 30, |
| |
2020 |
|
2019 |
| Operating
activities |
|
|
|
|
Net loss |
$ |
(24,183 |
) |
|
$ |
(62,101 |
) |
| Adjustments to reconcile net
loss to net cash used for operating activities: |
|
|
|
|
Share-based compensation expense |
3,997 |
|
|
13,103 |
|
|
Depreciation and amortization expense |
1,798 |
|
|
2,263 |
|
|
Loss on disposal of equipment |
904 |
|
|
15 |
|
|
Unrealized gains on short-term investments |
(63 |
) |
|
— |
|
|
Non-cash interest expense |
3,392 |
|
|
4,678 |
|
|
Non-cash rent expense |
699 |
|
|
639 |
|
| Changes in operating assets
and liabilities: |
|
|
|
|
Accounts receivable, net |
1,117 |
|
|
(512 |
) |
|
Inventory, net |
(909 |
) |
|
52 |
|
|
Prepaid expenses and other current assets |
1,675 |
|
|
22 |
|
|
Accounts payable |
(1,696 |
) |
|
(3,664 |
) |
|
Accrued expenses |
(3,378 |
) |
|
974 |
|
|
Accrued payroll and related expenses |
(2,591 |
) |
|
(3,429 |
) |
|
Lease liability |
(1,357 |
) |
|
(1,241 |
) |
| Net cash used for operating
activities |
(20,595 |
) |
|
(49,201 |
) |
| Investing
activities |
|
|
|
|
Proceeds from the sale of property and equipment |
2,860 |
|
|
— |
|
|
Purchase of property and equipment |
— |
|
|
(441 |
) |
|
Purchase of short-term investments |
(2,999 |
) |
|
— |
|
| Net cash used for investing
activities |
(139 |
) |
|
(441 |
) |
| Financing
activities |
|
|
|
|
Net proceeds from issuance of common stock under 2013 Equity
Plan |
605 |
|
|
— |
|
|
Net proceeds from issuance of common stock under ESPP |
359 |
|
|
484 |
|
| Net cash provided by financing
activities |
964 |
|
|
484 |
|
| Net decrease in cash
and restricted cash |
(19,770 |
) |
|
(49,158 |
) |
| Cash and restricted cash at
beginning of period |
88,729 |
|
|
173,513 |
|
| Cash and restricted
cash at end of period |
$ |
68,959 |
|
|
$ |
124,355 |
|
| 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 and restricted cash to the condensed
consolidated balance sheets |
| Cash |
$ |
68,353 |
|
|
$ |
123,446 |
|
| Restricted cash |
606 |
|
|
909 |
|
| Total cash and
restricted cash |
$ |
68,959 |
|
|
$ |
124,355 |
|
| |
|
|
|
|
|
|
|
La Jolla Pharmaceutical Company ContactMichael
HearneChief Financial OfficerLa Jolla Pharmaceutical Company(858)
333-5769mhearne@ljpc.com
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