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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Xenoport, Inc. | NASDAQ:XNPT | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 7.07 | 7.03 | 7.06 | 0 | 01:00:00 |
HORIZANT Net Product Sales Increased 67% Over Second Quarter 2014
XenoPort, Inc. (Nasdaq: XNPT) announced today financial results for the second quarter and six months ended June 30, 2015. Total revenues for the second quarter were $8.6 million, compared to $5.3 million for the same period in 2014. Net loss for the second quarter was $24.5 million, compared to a net loss of $19.4 million for the same period in 2014. At June 30, 2015, XenoPort had cash, cash equivalents and short-term investments of $170.4 million.
XenoPort Business Updates
The following key events occurred since the beginning of the second quarter of 2015:
Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, stated, “In the second quarter, we saw strong growth of HORIZANT prescriptions and net sales. With the recent addition of approximately 50 new Neuroscience Health Specialists to educate a broader pool of healthcare providers about HORIZANT, we believe that there will be an acceleration of growth in HORIZANT sales in the second half of the year and that we are on track to meet our net sales guidance of $39 to $43 million for 2015. We are excited that the NIAAA has initiated its AUD study of HORIZANT. This large study of approximately 350 subjects will provide important information about HORIZANT as a potential treatment for patients with AUD.”
Dr. Barrett continued, “Our XP23829 Phase 2 clinical trial in patients with moderate-to-severe chronic plaque-type psoriasis is nearing completion and, as previously indicated, we look forward to reporting the top-line results by the end of the third quarter. We believe this trial has the potential to be the first demonstration of efficacy of a monomethyl fumarate prodrug other than dimethyl fumarate and that XP23829 could provide a differentiated profile with potential for once-a-day dosing, reduced flushing and/or better GI tolerability.”
XenoPort Second Quarter and Six-Month Financial Results
Total revenues for the second quarter and six months ended June 30, 2015 were $8.6 million and $15.7 million, respectively, compared to $5.3 million and $8.7 million, respectively, for the same periods in 2014. The increase in revenues in both the second quarter and six months ended June 30, 2015 was principally due to increased HORIZANT net product sales, which totaled $8.2 million and $14.9 million for the second quarter and six months ended June 30, 2015, respectively. The increase in HORIZANT net product sales in both the second quarter and six months ended June 30, 2015 was principally due to increased sales volume, and, to a lesser extent, an increase in average net selling prices.
Research and development expenses for the second quarter and six months ended June 30, 2015 were $6.2 million and $12.6 million, respectively, compared to $5.2 million and $9.9 million, respectively, for the same periods in 2014. The increase in research and development expenses in the second quarter and six months ended June 30, 2015 was principally due to increased net costs for XP23829 primarily due to increased toxicology, clinical and manufacturing costs, offset in part by a reduction in personnel costs.
Selling, general and administrative expenses for the second quarter and six months ended June 30, 2015 were $25.6 million and $45.7 million, respectively, compared to $18.9 million and $37.6 million, respectively, for the same periods in 2014. The increase in selling, general and administrative expenses in both the second quarter and six months ended June 30, 2015, compared to the same periods in 2014, was principally due to costs related to the continued and expanded commercialization of, and promotional activities for, HORIZANT.
Net loss for the second quarter of 2015 was $24.5 million, compared to a net loss of $19.4 million for the same period in 2014. Net loss for the six months ended June 30, 2015 was $44.9 million, compared to a net loss of $39.9 million for the same period in 2014. Basic and diluted net loss per share were both $0.39 in the second quarter of 2015 versus basic and diluted net loss per share of $0.31 for the same period in the prior year. For the six months ended June 30, 2015, basic and diluted net loss per share were both $0.71 versus basic and diluted net loss per share of $0.67 for the same period in 2014.
Conference Call
XenoPort will host a conference call at 5:00 p.m. Eastern Time today to discuss its financial results and provide an update of XenoPort’s business. To access the conference call via the Internet, go to www.XenoPort.com. To access the live conference call via phone, dial 1-888-275-3514. International callers may access the live call by dialing 706-679-1417. The reference number to enter the call is 82478839.
The replay of the conference call will be available for one week and may be accessed after 8:00 p.m. Eastern Time today via the Internet, at www.XenoPort.com, or via phone at 1-855-859-2056 for domestic callers, or 404-537-3406 for international callers. The reference number to enter the replay of the call is 82478839.
About XenoPort
XenoPort, Inc. is a biopharmaceutical company focused on developing and commercializing a portfolio of internally discovered product candidates for the potential treatment of neurological disorders. XenoPort is currently commercializing HORIZANT® (gabapentin enacarbil) Extended-Release Tablets in the United States and developing its novel fumaric acid ester product candidate, XP23829, as a potential treatment for patients with moderate-to-severe chronic plaque-type psoriasis and potentially for relapsing forms of multiple sclerosis. REGNITE® (gabapentin enacarbil) Extended-Release Tablets is being marketed in Japan by Astellas Pharma Inc. XenoPort has entered into a collaboration with the National Institute on Alcohol Abuse and Alcoholism for the development of HORIZANT as a potential treatment for AUD and has granted exclusive world-wide rights for the development and commercialization of its clinical-stage oral product candidate, arbaclofen placarbil, to Indivior PLC for all indications. XenoPort's pipeline of product candidates also includes a potential treatment for patients with idiopathic Parkinson's disease.
Forward-Looking Statements
This press release contains “forward-looking” statements, including, without limitation, all statements related to XenoPort’s belief that there will be an acceleration of growth in HORIZANT sales in the second half of 2015 and that it is on track to meet its sales guidance of $39 to $43 million for 2015; the XP23829 clinical development program; XenoPort's expectation that it will obtain top-line results of the Phase 2 clinical trial of XP23829 by the end of the third quarter of 2015; the suitability of XP23829 as a potential treatment for moderate-to-severe chronic plaque-type psoriasis and/or relapsing forms of MS; the clinical development of HORIZANT by the NIAAA, including enrollment in and the potential benefits of the initiated AUD study of HORIZANT; the suitability of HORIZANT as a potential treatment for AUD; and the therapeutic and commercial potential of XenoPort’s product candidates. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believe,” “could,” “look forward,” “potential,” “will” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon XenoPort's current expectations. Forward-looking statements involve risks and uncertainties. XenoPort's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to XenoPort’s relative lack of commercialization experience and its ability to successfully market and sell HORIZANT, including XenoPort's ability to maintain a sales force comprising of both XenoPort-employed sales representatives and contract sales representatives, and XenoPort’s reliance on its contract sales organization to maintain sales, marketing, distribution, supply chain and other sufficient capabilities to sell HORIZANT; XenoPort's dependence on the success of its strategies for HORIZANT commercialization, promotion and distribution, as well as its ability to successfully execute on these activities and to comply with applicable laws, regulations and regulatory requirements; the competitive environment for and the degree of market acceptance of HORIZANT; obtaining appropriate pricing and reimbursement for HORIZANT in an increasingly challenging environment; the difficulty and uncertainty of pharmaceutical product development and the uncertain results and timing of clinical trials and other studies, including the risk that success in preclinical testing and early clinical trials do not ensure that later clinical trials will be successful, and that the results of clinical trials by other parties may not be indicative of the results in trials that XenoPort may conduct; XenoPort's ability to successfully advance XP23829 development and to conduct the Phase 2 clinical trial of XP23829 and report data therefrom in the anticipated timeframes, or at all; the risk that the completion of the Phase 2 clinical trial of XP23829 may be delayed or the trial terminated; the risk that XP23829 will require significant additional clinical testing prior to any possible regulatory approvals and failure could occur at any stage of its development; the uncertainty of the FDA’s review process and other regulatory requirements; the risk that even if HORIZANT is approved for the treatment of AUD, XenoPort may be unable to, or may otherwise be unsuccessful in, expanding the commercial opportunity for HORIZANT; XenoPort’s dependence on collaborative partners; the availability of resources to develop XenoPort’s product candidates and support XenoPort's operations; XenoPort’s substantial outstanding debt and debt service obligations, which could, among other things, limit its flexibility in planning for, or reacting to, changes in its business and its industry; the uncertain therapeutic and commercial value of XenoPort’s product candidates; as well as risks related to future opportunities and plans, including the uncertainty of expected future sales growth and other financial performance and results. These and other risk factors are discussed under the heading "Risk Factors" in XenoPort's Securities and Exchange Commission filings and reports, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2015, filed with the Securities and Exchange Commission on May 7, 2015. XenoPort expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
XENOPORT, HORIZANT and REGNITE are registered trademarks of XenoPort, Inc.
XNPT2F
XENOPORT, INC.
BALANCE SHEETS
(In thousands)
June 30,
December 31,
2015 2014 (Unaudited) Current assets: Cash and cash equivalents $ 31,360 $ 11,958 Short-term investments 139,057 90,098 Accounts receivable 3,494 2,895 Inventories 1,894 1,458 Prepaids, restricted investments and other current assets 7,338 3,185 Total current assets 183,143 109,594 Property and equipment, net 2,208 2,422 Long-term inventories 8,381 9,098 Restricted investments and other assets 105 1,947 Total assets $ 193,837 $ 123,061 Liabilities: Current liabilities $ 16,522 $ 17,788 Convertible senior notes, net 111,520 - Other noncurrent liabilities 13,840 14,133 Total liabilities 141,882 31,921 Stockholders’ equity: Common stock 63 62 Additional paid-in capital and other 683,598 677,894 Accumulated deficit (631,706 ) (586,816 ) Total stockholders’ equity 51,955 91,140 Total liabilities and stockholders’ equity $ 193,837 $ 123,061
XENOPORT, INC.
STATEMENTS OF OPERATIONS
(Unaudited)
Three Months
Ended June 30,
Six Months
Ended June 30,
2015
2014
2015
2014
(In thousands, except per share amounts)
Revenues: Product sales, net $ 8,214 $ 4,920 $ 14,853 $ 7,877 Collaboration revenue 283 283 567 566 Royalty revenue 124 131 268 266 Total revenues 8,621 5,334 15,688 8,709 Operating expenses: Cost of product sales 506 599 960 1,029 Research and development* 6,215 5,203 12,599 9,860 Selling, general and administrative* 25,554 18,865 45,653 37,636 Total operating expenses 32,275 24,667 59,212 48,525 Loss from operations (23,654 ) (19,333 ) (43,524 ) (39,816 ) Interest income 151 66 267 115 Interest expense (978 ) (120 ) (1,633 ) (234 ) Net loss $ (24,481 ) $ (19,387 ) $ (44,890 ) $ (39,935 ) Basic and diluted net loss per share $ (0.39 ) $ (0.31 ) $ (0.71 ) $ (0.67 ) Shares used to compute basic and diluted net loss per share 62,920 61,994 62,821 59,441* Includes non-cash stock-based compensation as follows:
Research
and development
$
747
$
622
$
1,129
$
1,324
Selling, general
and administrative
2,449
1,803
4,738
3,785
Total
$
3,196
$
2,425
$
5,867
$
5,109
HORIZANT® (gabapentin enacarbil) Extended-Release Tablets
INDICATION
HORIZANT is a prescription medicine used to treat adults with moderate-to-severe primary Restless Legs Syndrome (RLS). HORIZANT is not for people who need to sleep during the daytime and stay awake at night.
IMPORTANT SAFETY INFORMATION
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. See Medication Guide. To learn more about HORIZANT, please visit the Web site at www.Horizant.com.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150805006565/en/
Company Contact:XenoPort, Inc.Jackie Cossmon, 408-616-7220ir@XenoPort.com
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