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Pacira Pharmaceuticals, Inc. Reports First Quarter EXPAREL Revenues of $56.0 Million and First Quarter 2015 Financial Results
EXPAREL® Net Sales up 63% from Prior Year Period
Conference Call Today at
“With just a two percent market share of the approximately 42 million
addressable procedures for the current infiltration indication, we
remain confident in the long-term outlook for EXPAREL,” said
Complete Response Letter: In March, Pacira announced receipt of
a Complete Response Letter (CRL) from the
U.S. Food and Drug Administration( FDA) following a review of its supplemental New Drug Application (sNDA) for the use of EXPAREL in nerve block to provide postsurgical analgesia.
Studies Continue to Demonstrate Health Economic Benefits of Using
EXPAREL in Knee and Hip Surgeries: An analysis of 2,248 patients
undergoing total hip and knee replacement surgery was presented at the
American Academy of Orthopedic Surgeons(AAOS) annual meeting. Patients receiving periarticular injections (PAI) of EXPAREL vs. PAI of bupivacaine HCl, with or without ketorolac, and morphine reported significantly lower pain scores, were more likely to report “zero pain” during their hospital stay, experienced improved satisfaction and were associated with an average cost savings of $1,246per patient (approximately $1.5 millionin overall hospital savings).
Data Shows Significant Reductions in Opioid Consumption in TAP
infiltration procedures: Study results evaluating patients who
received either bupivacaine HCl or EXPAREL infiltrated into the
transversus abdominis plane (TAP) following robotic assisted
hysterectomy were presented at the annual meeting of the
International Anesthesia Research Society(IARS). According to the data, EXPAREL patients experienced significantly decreased opioid intake, reduced incidence of nausea and vomiting and lower maximal pain intensity at the time points assessed (0-24 hours, 24-48 hours and 48-72 hours).
Subpoena: In April, Pacira announced that it received a
subpoena from the
U.S. Department of Justice, U.S. Attorney’s Office for the District of New Jersey, requiring the production of a broad range of documents pertaining to marketing and promotional practices related to the product EXPAREL. Pacira intends to cooperate with the government’s investigation.
First Quarter 2015 Financial Results
EXPAREL net product revenues were
$56.0 millionin the first quarter of 2015, compared to $34.4 millionin the first quarter of 2014.
Total revenues were
$58.3 millionin the first quarter of 2015, compared to $36.7 millionin the first quarter of 2014.
Total operating expenses were
$55.0 millionin the first quarter of 2015, compared to $45.9 millionin the first quarter of 2014.
GAAP net income was
$1.3 million, or $0.03per share (basic and diluted), in the first quarter of 2015, compared to a GAAP net loss of ($11.5) million, or ($0.34)per share (basic and diluted), in the first quarter of 2014.
Non-GAAP net income was
$9.8 million, or $0.27per share (basic) and $0.23per share (diluted), in the first quarter of 2015, compared to a non-GAAP net loss of ($6.5) million, or ($0.19)per share (basic and diluted), in the first quarter of 2014.
Pacira ended the first quarter of 2015 with cash and cash equivalents,
short-term investments and long-term investments (“cash”) of
- Pacira had 36.2 million basic and 41.8 million diluted weighted average shares of common stock outstanding in the first quarter of 2015.
Given the current lack of visibility on EXPAREL sales resulting from the combined impact of recent regulatory developments and the government investigation, Pacira is suspending full year 2015 guidance for EXPAREL revenues and non-GAAP product gross margins.
Excluding stock-based compensation, Pacira expects the following non-GAAP operating expenses for 2015:
Research and development (R&D) expense of
$25 million to $30 million.
Selling, general and administrative (SG&A) expense of
$115 millionto $125 million.
Today’s Conference Call and Webcast Reminder
The Pacira management team will host a conference call to discuss the
company’s financial results and recent developments today,
A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and providing the Conference ID 83470502. The replay of the call will be available for two weeks from the date of the live call.
The live, listen-only webcast of the conference call can also be accessed by visiting the “Investors & Media” section of the company’s website at investor.pacira.com. A replay of the webcast will be archived on the Pacira website for two weeks following the call.
Non-GAAP Financial Information
This press release contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), non-GAAP net income (loss), because such measures exclude stock-based compensation and amortization of debt discount. These measures supplement our financial results prepared in accordance with GAAP. Pacira management uses these measures to better analyze its financial results and to help make managerial decisions. In management’s opinion, these non-GAAP measures are useful to investors and other users of our financial statements by providing greater transparency into the operating performance at Pacira. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Non-GAAP net income (loss) measures are also unlikely to be comparable with non-GAAP disclosures released by other companies. See a reconciliation of non-GAAP net income (loss) to GAAP net loss below.
The range of R&D and SG&A expenditure outlook for 2015 are non-GAAP financial measures because they exclude stock-based compensation charges. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Non-GAAP financial measures are also unlikely to be comparable with non-GAAP disclosures released by other companies.
EXPAREL (bupivacaine liposome injectable suspension) is currently indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. The product combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain score with up to a 45 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.
Important Safety Information
EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence greater-than or equal to 10%) following EXPAREL administration were nausea, constipation, and vomiting.
Please see the full Prescribing Information for more details available at http://www.exparel.com/pdf/EXPAREL_Prescribing_Information.pdf.
Forward Looking Statements
Any statements in this press release about our future expectations,
plans, outlook and prospects, including statements about expected
non-GAAP operating expenses, and other statements containing the words
“believes,” “anticipates,” “plans,” “estimates,” “expects,” and similar
expressions, constitute forward-looking statements within the meaning of
The Private Securities Litigation Reform Act of 1995. Actual results may
differ materially from those indicated by such forward-looking
statements as a result of various important factors, including risks
relating to: the success of our sales and manufacturing efforts in
support of the commercialization of EXPAREL; the rate and degree of
market acceptance of EXPAREL; the size and growth of the potential
markets for EXPAREL and our ability to serve those markets; our plans to
expand the use of EXPAREL to additional indications, including nerve
block, oral surgery and chronic pain, as well as pediatrics; the related
timing and success of a
|Pacira Pharmaceuticals, Inc.|
|Condensed Consolidated Balance Sheets|
|March 31,||December 31,|
|Cash and cash equivalents, restricted cash and short-term investments||$||154,886||$||158,167|
|Accounts receivable, net||24,511||22,366|
|Prepaid expenses and other current assets||4,089||4,461|
|Total current assets||219,750||214,257|
|Fixed assets, net||67,206||60,632|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Convertible senior notes ( * )||104,135||103,100|
|Current portion of royalty interest obligation||-||276|
|Current portion of deferred revenue||1,426||1,426|
|Income taxes payable||31||139|
|Total current liabilities||136,453||140,010|
|Total stockholders' equity||184,021||171,145|
|Total liabilities and stockholders' equity||$||335,030||$||326,072|
( * ) The convertible senior notes are contractually due in 2019. However, because of certain conditions that were met during the three months ended March 31, 2015, the note holders can convert any time during the quarter ended June 30, 2015.
|Pacira Pharmaceuticals, Inc.|
|Consolidated Statements of Operations|
|(in thousands, except per share amounts)|
|Three Months Ended|
|EXPAREL net product sales||$||55,951||$||34,401|
|DepoCyt(e) net product sales||1,135||1,341|
|Collaborative licensing and development revenue||356||252|
|Cost of goods sold||17,580||18,127|
|Research and development||5,967||5,204|
|Selling, general and administrative||31,428||22,589|
|Total operating expenses||54,975||45,920|
|Income (loss) from operations||3,341||(9,258||)|
|Other (expense) income:|
|Royalty interest obligation||(71||)||(120||)|
|Total other expense, net||(2,029||)||(2,219||)|
|Income (loss) before income taxes||1,312||(11,477||)|
|Income tax expense||(52||)||-|
|Net income (loss)||$||1,260||$||(11,477||)|
|Net income (loss) per share:|
|Basic and diluted net income (loss) per common share||$||0.03||$||(0.34||)|
|Weighted average common shares outstanding:|
|Pacira Pharmaceuticals, Inc.|
|Reconciliation of GAAP to Non-GAAP Financial Information|
|(in thousands, except per share amounts)|
|Three Months Ended|
|GAAP net income (loss)||$||1,260||$||(11,477||)|
|Non-cash debt discount amortization||1,035||1,035|
|Total Non-GAAP adjustments||8,552||5,010|
|Non-GAAP net income (loss)||$||9,812||$||(6,467||)|
|GAAP basic and diluted net income (loss) per common share||$||0.03||$||(0.34||)|
|Non-GAAP basic net income (loss) per common share||$||0.27||$||(0.19||)|
|Non-GAAP diluted net income (loss) per common share||$||0.23||$||(0.19||)|
|Weighted average common shares outstanding - basic||36,235||33,711|
|Weighted average common shares outstanding - diluted||41,779||33,711|
|Cost of goods sold reconciliation:|
|GAAP cost of goods sold||$||17,580||$||18,127|
|Stock-based compensation expense||(1,103||)||(494||)|
|Non-GAAP cost of goods sold||$||16,477||$||17,633|
|Research and development reconciliation:|
|GAAP research and development||$||5,967||$||5,204|
|Stock-based compensation expense||(1,510||)||(1,577||)|
|Non-GAAP research and development||$||4,457||$||3,627|
|Selling, general and administrative reconciliation:|
|GAAP selling, general and administrative||$||31,428||$||22,589|
|Stock-based compensation expense||(4,904||)||(1,904||)|
|Non-GAAP selling, general and administrative||$||26,524||$||20,685|
Pacira Pharmaceuticals, Inc.
Jessica Cho, 973-254-3574
Pure Communications, Inc.
Susan Heins, 864-286-9597