Full Press Release Details
Not For Immediate Release
Communications Manager
Vanda Pharmaceuticals Inc.
Vanda Pharmaceuticals Reports Second Quarter 2010 Results
ROCKVILLE, MD. August 5, 2010 Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA),
a biopharmaceutical company focused on the development and commercialization of products for
central nervous system disorders, today announced financial and operational results for the second
quarter and six months ended June 30, 2010.
| Vanda records year to date revenue of $20.7 million including year to date royalties of $2.1 million. | |||
| Fanapt prescriptions continued to increase month-over-month during the second quarter of 2010. Monthly prescriptions of Fanapt , as reported by IMS, increased from approximately 500 in February 2010 (the first full month of sales) to over 4,000 in June of 2010. | |||
| On August 3, 2010, the U.S. Patent and Trademark Office (USPTO) issued a patent for a microsphere, long-acting injectable (depot) formulation of iloperidone. The USPTO has informed Vanda that the patent term adjustment included an additional 605 days, making the patent expiration date June 27, 2023. | |||
| Phase III studies of tasimelteon for the treatment of Non-24-Hour Sleep/Wake Disorder (N24HSWD) in blind individuals with no light perception to be initiated in the third quarter of 2010. |
Total revenue for the second quarter of 2010 was $8.3 million, compared to $12.4 million for the
first quarter of 2010 and $0 for the second quarter of 2009. Total operating expenses for the
second quarter of 2010 were $7.1 million, compared to $6.3 million for the first quarter of 2010
and $12.4 million for the second quarter of 2009. Net income was $1.3 million for the second
quarter of 2010 compared to net income of $0.5 million for the first quarter of 2010 and a net loss
of $12.4 million for the second quarter of 2009.
Vanda s cash, cash equivalents, and marketable securities as of June 30, 2010 totaled approximately
$207.1 million. Approximately 28.0 million shares of Vanda common stock were outstanding as of
June 30, 2010. Basic and diluted net income per common share for the second quarter of 2010 were
$0.05 and $0.04, respectively, compared to basic and diluted net income per common share of $0.02
for the first quarter of 2010 and a basic and diluted net loss per common share of $0.46 for the
second quarter of 2009.
Year to date June 30, 2010 Key Financial Figures1
| YTD 6/30/10($) | YTD 6/30/09($) | Change ($) | Change (%) | |||||||||||||
| Total revenues | 20,711,000 | 20,711,000 | N/A | |||||||||||||
| R D expenses | 4,444,000 | 9,529,000 | (5,085,000 | ) | -53 | % | ||||||||||
| G A expenses | 5,331,000 | 9,212,000 | (3,881,000 | ) | -42 | % | ||||||||||
| Employee non-cash stock-based compensation | 2,733,000 | 5,057,000 | (2,324,000 | ) | -46 | % | ||||||||||
| Net income (loss) before tax provision | 7,436,000 | (18,896,000 | ) | N/A | N/A | |||||||||||
| Tax provision | 5,628,000 | 5,628,000 | N/A | |||||||||||||
| Net income (loss) | 1,809,000 | (18,896,000 | ) | N/A | ||||||||||||
| Basic net income per share attributable to common stockholders | 0.07 | (0.71 | ) | N/A | ||||||||||||
| Diluted net income per share attributable to common stockholders | 0.06 | (0.71 | ) | N/A |
Second Quarter 2010 Key Financial Figures1
| Q2 2010 ($) | Q1 2010 ($) | Change ($) | Change (%) | |||||||||||||
| Total revenues | 8,290,000 | 12,421,000 | (4,131,000 | ) | -33 | % | ||||||||||
| R D expenses | 2,404,000 | 2,041,000 | 363,000 | 18 | % | |||||||||||
| G A expenses | 2,842,000 | 2,489,000 | 353,000 | 14 | % | |||||||||||
| Employee non-cash stock-based compensation | 1,644,000 | 1,089,000 | 555,000 | 51 | % | |||||||||||
| Net income before tax provision | 1,242,000 | 6,195,000 | (4,953,000 | ) | -80 | % | ||||||||||
| Tax (benefit) provision | (38,000 | ) | 5,665,000 | N/A | N/A | |||||||||||
| Net income | 1,279,000 | 529,000 | 750,000 | 142 | % | |||||||||||
| Basic net income per share attributable to common stockholders | 0.05 | 0.02 | 0.03 | 150 | % | |||||||||||
| Diluted net income per share attributable to common stockholders | 0.04 | 0.02 | 0.02 | 100 | % | |||||||||||
| Total cash and marketable securities | 207,117,000 | 202,424,000 | 4,693,000 | 2 | % |
OPERATIONAL HIGHLIGHTS
Year-to-date net sales of Fanapt were reported by Novartis to be approximately $21.4 million
comprised of $20.7 million in the first quarter of 2010 and $0.7 million in the second quarter of
2010. Vanda is encouraged by the continuing growth in total number of monthly prescriptions, as
reported by IMS, and by the strengthened promotional launch of Fanapt since the approval of
marketing materials by the FDA in May 2010. Fanapt monthly prescriptions, as reported by
IMS, increased from approximately 500 in February 2010 (the first full month of sales) to over
4,000 in June of 2010.
On February 23, 2010, the USPTO issued a notice of allowance for Vanda s patent application of a
microsphere, long-acting injectable (depot) formulation of iloperidone. Subsequently, on
2010, the USPTO informed Vanda that the patent has been issued with a patent term adjustment of an
additional 605 days, extending the patent expiration date to June 27, 2023. Novartis is responsible
for the further development of the depot formulation in the U.S and Canada. Vanda has retained the
rights for the development and commercialization of the iloperidone depot formulation outside the
U.S. and Canada. Vanda also continues to explore the regulatory path and commercial opportunity for
Fanapt oral formulation outside of the U.S. and Canada.
With respect to tasimelteon, Vanda is prepared to initiate an efficacy and safety study of
tasimelteon in the third quarter for the treatment of Non-24-Hours Sleep/Wake Disorder (N24HSWD) in
blind individuals with no light perception. This trial will be a randomized, double-blind,
placebo-controlled study with an enrollment of approximately 160 patients with N24HSWD. The trial
will have a 6-month treatment period and will include measures of both nighttime and daytime sleep,
as well as laboratory measures of the synchronization between the internal body clock and the
24-hour environmental light/dark cycle.
Vanda is also prepared to initiate a one-year safety study of tasimelteon for the treatment of
N24HSWD. This will be an open-label safety study that will enroll approximately 140 patients with
N24HSWD. Vanda plans to conduct additional clinical trials over the next one to two years to
support U.S. and European regulatory submissions. Tasimelteon was granted orphan drug designation
by the FDA on January 19, 2010. The application for orphan designation from the European Medicines
| Revenues decreased by $4.1 million from $12.4 million to $8.3 million for the second quarter of 2010 due to decreases of $2.1 million in product revenue for inventory sold to Novartis and $2.0 million in royalty revenue. Vanda sold the remaining Fanapt inventory to Novartis in the second quarter of 2010. Despite a significant growth of Fanapt prescription demand in the second quarter, royalty revenue decreased from the first quarter due to stocking of pharmacies in the first quarter. | ||
| Cost of sales for the second quarter of 2010 was $1.9 million, consisting of $0.4 million resulting from the amortization of the capitalized intangible asset related to the milestone payment to Novartis and $1.5 million for the inventory sold to Novartis, compared to cost of sales for the first quarter of 2010 of $1.8 million, consisting of $0.4 million resulting from the amortization of the capitalized intangible asset related to the milestone payment to Novartis and $1.4 million for inventory sold to Novartis. | ||
| Research and development (R D) expenses were $2.4 million for the second quarter of 2010, compared to $2.0 million for the first quarter of 2010 and $7.2 million for the second quarter of 2009. The increase in R D expenses in the second quarter of 2010 relative to the first quarter of 2010 is primarily due to costs incurred in connection with the preparation of the Phase III trials for tasimelteon in N24HSWD. | ||
| General and administrative (G A) expenses were $2.8 million for the second quarter of 2010, compared to $2.5 million for the first quarter of 2010 and $5.0 million for the second quarter of 2009. The increase in G A expenses in the second quarter of 2010 relative to the first quarter of 2010 is primarily due to the higher non-cash stock-based compensation costs in the second quarter of 2010. | ||
| Employee stock-based compensation expense recorded in the second quarter of 2010 totaled $1.6 million, compared to $1.1 million for the first quarter of 2010 and $2.8 million for the second quarter of 2009. The increase in employee stock-based compensation expense in the second quarter of 2010 relative to the first quarter of 2010 is the result of the |
| cancellation of unvested options in the first quarter of 2010, which reduced the first quarter 2010 expense. | ||
| Tax provision: Vanda recorded a tax benefit of $38,000 in the second quarter of 2010. The tax provision is based on an annualized effective tax rate for 2010 applied to the year to date pre-tax book income with the addition or subtraction of discrete items. The quarterly tax provision is not indicative of estimated quarterly cash tax payments. The tax provision rate applied in 2010 was determined primarily based upon a net increase in valuation allowance for excess of the deferred revenue recorded from the $200.0 million upfront milestone payment received from Novartis at the end of 2009 over the existing tax attributes utilized. The provision also includes the impact of tax credits relating to the orphan drug designation for tasimelteon. Vanda will continue to evaluate its qualified expenses for the orphan drug tax credit and, to the extent that actual qualified expenses vary significantly from Vanda s estimates, Vanda s effective tax rate will increase or decrease accordingly. | ||
| Vanda s cash, cash equivalents and marketable securities as of June 30, 2010 totaled approximately $207.1 million, compared to approximately $202.4 million as of March 31, 2010. Cash, cash equivalents and marketable securities increased by $4.7 million during the second quarter of 2010. Changes included: $1.3 million of net income, an increase in non-cash items of $2.0 million, the receipt of $5.4 million in amounts due from Novartis for the remaining finished product and royalty revenue, a decrease in inventory of $1.5 million for the final inventory sold to Novartis, a decrease of $6.7 million in the deferred revenue related to the upfront payment received from Novartis in December 2009, an increase in other working capital of $0.5 million and $0.7 million received in financing activities from the exercise of stock options. | ||
| Net income for the second quarter of 2010 was $1.3 million, compared to net income of $0.5 million for the first quarter of 2010 and a net loss of $12.4 million for the second quarter of 2009. | ||
| Basic and diluted net income per common share for the second quarter of 2010 were $0.05 and $0.04, respectively, compared to basic and diluted net income per common share of $0.02 for the first quarter of 2010 and a basic and diluted net loss of $0.46 for the second quarter of 2009. |
Vanda has scheduled a conference call for today, Thursday, August 5, 2010, at 10:00 AM ET. During
the call, Mihael H. Polymeropoulos, M.D., President and CEO, and Stephanie Irish, Acting CFO, will
discuss quarterly results and other corporate activities. Investors can call 1-866-788-0544
(domestic) and 1-857-350-1682 (international) prior to the 10:00 AM start time and ask for the
Vanda Pharmaceuticals conference call hosted by Dr. Polymeropoulos (participant passcode 57802480).
A replay of the call will be available Thursday, August 5, 2010 at 1:00 PM ET and will be
accessible until Thursday, August 12, 2010, at 5:00 PM ET. The replay call-in number is
1-888-286-8010 for domestic callers and 1-617-801-6888 for international callers. The access
The conference call will be broadcast simultaneously on Vanda s website,
http://www.vandapharma.com. Investors should click on the Investor Relations tab and are
advised to go to the website at least 15 minutes early to register, download, and install any
necessary software or presentations. The call will also be archived on Vanda s website for a
period of 30 days, through September 4, 2010.
ABOUT VANDA PHARMACEUTICALS INC.:
Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and
commercialization of products for central nervous system disorders. For more on Vanda
Pharmaceuticals Inc., please visit http://www.vandapharma.com.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Various statements in this release are forward-looking statements under the securities laws.
Words such as, but not limited to, believe, expect, anticipate, estimate, intend, plan,
targets, likely, will, would, and could, and similar expressions or words, identify
forward-looking statements. Forward-looking statements are based upon current expectations that
involve risks, changes in circumstances, assumptions and uncertainties. Important factors that
could cause actual results to differ materially from those reflected in the company s
forward-looking statements include, among others: the extent and effectiveness of the development,
sales and marketing and distribution support Fanapt receives; Vanda s inability to utilize a
substantial portion of its prior net operating losses and research and development credits; Vanda s
ability to successfully commercialize Fanapt outside of the U.S. and Canada; delays in the
completion of Vanda s clinical trials; a failure of Vanda s products to be demonstrably safe and
effective; Vanda s failure to obtain regulatory approval for its products or to comply with ongoing
regulatory requirements for its products; a lack of acceptance of Vanda s products in the
marketplace, or a failure to become or remain profitable; Vanda s expectations regarding trends
with respect to its costs and expenses; Vanda s inability to obtain the capital necessary to fund
additional research and development activities; Vanda s failure to identify or obtain rights to new
products; Vanda s failure to develop or obtain sales, marketing and distribution resources and
expertise or to otherwise manage its growth; a loss of any of Vanda s key scientists or management
personnel; losses incurred from product liability claims made against Vanda; a loss of rights to
develop and commercialize Vanda s products under its license and sublicense agreements and other
factors that are described in the Risk Factors and Management s Discussion and Analysis of
Financial Condition and Results of Operations sections of Vanda s annual report on Form 10-K for
the fiscal year ended December 31, 2009 and quarterly report on Form 10-Q for the fiscal quarter
ended March 31, 2010, which are on file with the SEC and available on the SEC s website at
www.sec.gov. Additional information will also be set forth in those sections of Vanda s quarterly
report on Form 10-Q for the fiscal quarter ended June 30, 2010, which will be filed with the SEC in