Vertex Pharmaceuticals Reviews First Quarter Business Progress and Reports First Quarter 2009 Financial Results
VRTX | Quote | Chart | News | PowerRating -- --- VX-770 will start registration program in CF patients with G551D mutation -
---Vertex ends first quarter with $869 million of cash, cash equivalents and marketable securities-
Vertex
Pharmaceuticals Incorporated (Nasdaq: VRTX | Quote | Chart | News | PowerRating) today reviewed first
quarter 2009 business and clinical achievements and reported
consolidated financial results for the quarter ended March 31, 2009.
"With our strong performance in the first quarter, we are well
positioned to drive forward key programs in hepatitis C and cystic
fibrosis and to deliver on our 2009 financial projections outlined
earlier this year," said Matt Emmens, President of Vertex
Pharmaceuticals. "Our top priority is to execute on the telaprevir Phase
3 program and to prepare for an NDA filing for telaprevir in the second
half of 2010. Additionally, our cystic fibrosis program has made
remarkable progress and we expect to start a registration program for
VX-770 this quarter."
Mr. Emmens continued, "Since joining Vertex, I've been impressed with
the strong team of experienced and talented employees who are dedicated
to advancing the Company. With the PROVE 3 presentation of SVR data in
HCV patients who failed prior treatment with pegylated interferon and
ribavirin at EASL next week, the continued progress in the telaprevir
Phase 3 program and the initiation of a registration program for VX-770
in cystic fibrosis patients, it's an eventful and exciting time for
everyone at Vertex. I look forward to leading Vertex as we continue to
grow and transition toward a fully-integrated pharmaceutical company."
Broad Commitment to Hepatitis C
Phase 3 evaluation in treatment-naive and treatment-failure
patients
--
Vertex is conducting the Phase 3 ADVANCE study, evaluating the
hepatitis C virus (HCV) protease inhibitor telaprevir (8 or 12 weeks
of dosing, depending on treatment arm assignment), or placebo, as part
of a combination regimen with pegylated interferon (peg-IFN) and
ribavirin (RBV) in more than 1,050 patients. The global 3-arm trial is
focused on response-guided 24-week telaprevir-based regimens in
genotype 1 treatment-naive HCV patients. In January, the telaprevir
dosing portion of the ADVANCE trial was completed.
--
Vertex is conducting ILLUMINATE, a global 2-arm trial that is
evaluating response-guided telaprevir-based regimens in approximately
500 genotype 1 treatment-naive HCV patients. This trial is designed to
supplement sustained viral response (SVR) data obtained from the
pivotal Phase 3 ADVANCE trial. The aim of the ILLUMINATE trial is to
characterize whether there is an additional benefit to extending
treatment from 24 to 48 weeks in treatment-naive patients who achieved
undetectable HCV RNA at weeks 4 and 12 of treatment. Vertex announced
today that the telaprevir dosing portion of the ILLUMINATE trial has
been completed.
--
Tibotec is conducting the Phase 3 REALIZE trial, which is evaluating
treatment with telaprevir-based regimens in more than 650 patients
with genotype 1 HCV who failed to achieve an SVR with prior treatment
of peg-IFN and RBV, and which enrolled all major treatment-failure
groups including null responders. The REALIZE trial completed
enrollment in February and Vertex expects the telaprevir dosing
portion of the REALIZE trial to be complete in May.
Telaprevir twice-daily evaluation
--
Tibotec is conducting Study C208, a Phase 2, open-label clinical study
in Europe that is evaluating a twice-daily (1125mg q12h) dosing
schedule of telaprevir in combination with peg-IFN-alfa-2a (PEGASYS(R))
or peg-IFN-alfa-2b (PEGINTRON(TM)) and RBV, as compared to the current
three-times-daily (750 mg q8h) dosing schedule. In an interim analysis
conducted at 12 weeks, more than 80% of patients who received the
telaprevir-based combination either twice-daily or three times daily
with PEGASYS or PEGINTRON had undetectable HCV RNA at week 4 and week
12. The type and frequency of adverse events across the study arms
were generally consistent with previous studies of telaprevir. No
substantial differences in the safety profile or viral breakthrough
rates between the two different dosing regimens were observed. A
complete analysis will be performed upon the conclusion of this study.
Data obtained to date support the potential to continue developing
telaprevir as a twice-daily dosing regimen.
--
Study C208 is evaluating response-guided telaprevir-based regimens.
Patients who had undetectable HCV RNA at week 4 and week 12 were able
to stop all treatment at the end of 24 weeks, while the remaining
patients continued to receive peg-IFN and RBV for an additional 24
weeks for a total of 48 weeks of therapy. Vertex announced today that
24 or 48 weeks of dosing is complete in Study C208 and patients are
being followed post-treatment.
Additional Telaprevir Development Programs
--
Vertex has completed PROVE 3, a Phase 2b clinical trial of
telaprevir-based combination therapy in patients with genotype 1 HCV
who did not achieve an SVR with a previous peg-IFN-based treatment.
Full data will be presented as part of a late-breaker oral
presentation during the 44th Annual Meeting of the European
Association for the Study of the Liver (EASL) in Copenhagen on
Saturday, April 25, 2009.
--
In an interim analysis presented in November 2008, the PROVE 3 data
showed a 52% SVR12 in HCV treatment-failure patients, with a 24-week
treatment duration. Full data from PROVE 3 have been provided to the
U.S. FDA.
Enhanced Commitment to Future Treatment of HCV
--
In March, Vertex added to its HCV drug development portfolio through
the acquisition of ViroChem Pharma Inc., in a stock and cash
transaction. The acquisition added to Vertex's portfolio two
non-nucleoside polymerase inhibitors, VCH-222 and VCH-759, which have
each shown substantial reductions in plasma HCV RNA when dosed as
single agents and have been well-tolerated in clinical trials to date.
--
VCH-222 is an oral non-nucleoside inhibitor of the HCV NS5B
polymerase. In a 3-day viral kinetic study completed in late 2008,
VCH-222 resulted in a median 3.7 log10 decrease in HCV RNA
when dosed as 750 mg twice daily.
--
Vertex today announced that it is initiating a 3-day multi-dose viral
kinetic study to evaluate the antiviral activity, safety, tolerability
and pharmacokinetics of VCH-222 in patients with chronic genotype 1
HCV infection.
--
The study will evaluate the antiviral activity of VCH-222 dosed as
monotherapy for three days in approximately 32 treatment-naive
patients ages 18 to 65 years. The study will be conducted at up to
11 clinical trial sites in North America and Argentina.
--
Vertex expects to use data from the trial to inform the first
trial exploring STAT-C combinations of telaprevir.
Presentations at the European Association for the Study of the
Liver (EASL)
--
Three abstracts related to telaprevir were accepted for presentation
at the 44th Annual Meeting of the European Association for the Study
of the Liver (EASL) in Copenhagen, Denmark, April 22-26, 2009. The
accepted abstracts are a late breaker oral presentation of SVR rates
from the PROVE 3 clinical trial of telaprevir in patients who failed
prior HCV therapy, an oral presentation of data from Study C210 of
telaprevir in treatment-naive genotype 4 HCV patients, and an oral
presentation of data from Study C209 of telaprevir in treatment-naive
genotype 2 and 3 patients.
--
In addition, three abstracts related to Vertex's HCV polymerase
inhibitor VCH-222 were accepted as poster presentations, including a
presentation of the first clinical results for VCH-222 in HCV patients.
--
The abstracts can be accessed through the EASL website, www.easl.ch.
Additional HCV protease inhibitors in clinical development
--
Vertex is advancing a portfolio of additional HCV protease inhibitors,
VX-813 and VX-985. VX-813 has completed a multi-dose Phase 1a study in
healthy volunteers and VX-985 is in early development.
Broad Program Targeting Cystic Fibrosis Advancing
Potentiator compound VX-770 registration program
--
Vertex has agreement with regulatory authorities to initiate in the
second quarter of 2009 the registration program for VX-770, an
investigational Cystic Fibrosis Transmembrane Conductance Regulator
(CFTR) potentiator compound for the treatment of cystic fibrosis (CF).
--
The VX-770 registration program will consist of three separate trials:
a primary trial designed to enroll patients ages 12 and older who
carry the G551D mutation on at least one allele, a trial in patients
aged 6 to 11 with the G551D mutation on at least one allele, and the
first trial to evaluate patients homozygous for the F508del mutation.
--
The registration program will evaluate 48 weeks of VX-770 treatment
for patients with the G551D mutation, and will involve approximately
100 centers in the U.S. and Europe.
--
The primary endpoint of all trials in the VX-770 registration program
will be FEV1. Additional secondary endpoints, including
sweat chloride, will also be measured to determine the effect of
VX-770 on helping to restore the function of the defective CFTR
protein.
Corrector compound VX-809 in Phase 2a trial
--
In March, Vertex initiated a Phase 2a trial of VX-809, an
investigational CFTR corrector compound for the treatment of CF. The
trial is designed primarily to evaluate the safety and tolerability of
multiple doses of VX-809 in patients with the F508del CFTR mutation,
the most common mutation in CF patients. In addition to safety, the
study provides the first opportunity to evaluate the potential effect
of VX-809 on measures of CFTR function, including sweat chloride and
nasal potential difference. In the trial, VX-809's potential effect on
FEV1 will also be evaluated as a secondary measure. The
trial will initially evaluate two dose levels of VX-809 compared to
placebo given orally once daily for 28 days in a parallel design.
Following a planned interim analysis, the trial may evaluate an
additional two dose levels of VX-809 compared to placebo. The trial is
expected to be complete in early 2010.
Additional Advancements in Pipeline
--
Vertex recently completed an analysis of Phase 1 single and multiple,
14-day, dose-ranging studies of VX-509, a novel and highly selective
Janus Kinase 3 (JAK3) inhibitor. In these studies, VX-509 was
well-tolerated at all dose levels and demonstrated a promising
pharmacokinetic profile indicating the opportunity for a once-daily
oral dosing regimen. In both Phase 1 and prior in vitro studies,
VX-509 has shown highly selective inhibition of biomarkers of JAK3
activity, with no significant inhibition of JAK2 activity at targeted
exposures. VX-509 may have broad potential for the treatment of
multiple immune-mediated inflammatory diseases. In addition to VX-509,
Vertex has selected VX-467 as an additional drug candidate targeting
JAK3.
--
In order for Vertex to balance its portfolio, focus R&D investments,
and maximize the value of the JAK3 program, the Company is entering a
period of advanced licensing discussions with several potential
collaborators.
--
Vertex's collaborator, Merck & Co., Inc., is conducting a Phase 1
clinical trial of the Aurora kinase inhibitor MK-5108 (VX-689) in
patients with advanced and/or refractory tumors.
First Quarter Results
For the quarter ended March 31, 2009, the Company's GAAP net loss was
$161.5 million, or $1.04 per share, including stock-based compensation,
executive transition, acquisition related and restructuring expenses of
$34.0 million, compared to a GAAP net loss for the quarter ended March
31, 2008 of $96.2 million, or $0.72 per share, including stock-based
compensation and restructuring expenses of $13.7 million.
The non-GAAP loss, before stock-based compensation, executive
transition, acquisition related and restructuring expenses, for the
quarter ended March 31, 2009 was $127.5 million, or $0.82 per share,
compared to $82.5 million, or $0.61 per share, for the quarter ended
March 31, 2008. The increase in the Company's 2009 non-GAAP loss was
principally attributable to a decrease in collaborative revenues and an
increase in total operating expenses to support telaprevir's global
Phase 3 registration program and commercialization, and preparation for
advancement of VX-770 into a registration program.
Total revenues for the quarter ended March 31, 2009 were $24.8 million,
compared to $41.7 million for the first quarter of 2008. The decrease is
primarily due to a reduction in milestone revenues received in the first
quarter of 2008 that did not recur in 2009.
Research and development (R&D) expenses for the quarter ended March 31,
2009 were $143.6 million, compared to $116.3 million in R&D expenses for
the first quarter of 2008. The increase primarily reflects investment
activity to support advancement of Phase 3 trials for telaprevir as well
as preparation for advancement of VX-770 into a registration program for
cystic fibrosis.
Sales, general and administrative (SG&A) expenses for the quarter ended
March 31, 2009 were $28.1 million, compared to $19.9 million for the
first quarter of 2008. This increase reflects building of capabilities,
including an increase in the number of employees and our commercial
investments, to support advancement of telaprevir and VX-770 toward
potential launch.
Other expense, net, for the quarter ended March 31, 2009 was $0.8
million, compared to other income, net, of $2.6 million for the first
quarter of 2008. This decrease resulted from increased interest expense
and a lower level of investment portfolio yields reflecting the broader
economic environment.
At March 31, 2009, Vertex had $869.2 million in cash, cash equivalents
and marketable securities. Additionally, the Company has $287.5 million
of convertible senior subordinated debt due in 2013, with a conversion
price of $23.14 per share.
Full Year 2009 Financial Guidance
This section contains forward-looking guidance about the financial
outlook for Vertex Pharmaceuticals.
Vertex today is reiterating its guidance for 2009 non-GAAP loss, which
originally was provided on February 9, 2009. Specifically, this guidance
provided a non-GAAP loss of $400 million to $435 million. The Company is
also providing guidance for 2009 year-end cash, cash equivalents and
marketable securities of approximately $700 million.
Vertex today is revising its expectation for 2009 GAAP net loss to the
range of $500 million to $535 million, which includes $100 million of
stock-based compensation expense, executive transition expenses,
acquisition related expenses and restructuring expense.
"We are making disciplined investments focused on advancing our HCV and
CF programs, and on maintaining our product creation capabilities while
balancing these investments with respect to our financial profile," said
Ian Smith, Executive Vice President and Chief Financial Officer of
Vertex. "We raised capital for our business in the first quarter and we
recognize the importance of managing our balance sheet in this difficult
macroeconomic environment. We remain committed to the financial guidance
provided and reiterated today."
Non-GAAP Financial Measures
In this press release, Vertex's financial results are provided both in
accordance with accounting principles generally accepted in the United
States (GAAP) and using certain non-GAAP financial measures. In
particular, Vertex provides its first quarter 2009 and 2008 loss and
guidance for its projected 2009 loss, excluding restructuring expense,
acquisition related expenses, executive transition expenses, and
stock-based compensation expense, which in each case results in a
non-GAAP financial measure. These results are provided as a complement
to results provided in accordance with GAAP because management believes
these non-GAAP financial measures help indicate underlying trends in the
Company's business and are important in comparing current results with
prior period results. Management also uses these non-GAAP financial
measures to establish budgets and operational goals that are
communicated internally and externally, and to manage the Company's
business and to evaluate its performance. A reconciliation of non-GAAP
financial results to GAAP financial results is included in the attached
financial statements.
About Vertex
Vertex Pharmaceuticals Incorporated is a global biotechnology company
committed to the discovery and development of breakthrough small
molecule drugs for serious diseases. The Company's strategy is to
commercialize its products both independently and in collaboration with
major pharmaceutical companies. Vertex's product pipeline is focused on
viral diseases, cystic fibrosis, inflammation, autoimmune diseases,
cancer and pain. Vertex co-discovered the HIV protease inhibitor,
Lexiva, with GlaxoSmithKline.
Lexiva is a registered trademark of the GlaxoSmithKline group
of companies.
PEGASYS(R) is a registered trademark of Hoffman La Roche.
PEGINTRON(TM) is a trademark of Schering Corporation.
Special Note Regarding Forward-looking Statements
This press release contains forward-looking statements, including
statements regarding (i) the Company's expectation that it will begin
the VX-770 registration program in the second quarter, (ii) the Company
being well-positioned to drive forward its key programs in HCV and CF
and deliver on its 2009 financial projections, (iii) the Company's top
priority being executing on the telaprevir Phase 3 program and preparing
for filing an NDA for telaprevir in the second half of 2010, (iv) the
continued growth of the Company and the transition toward a
fully-integrated pharmaceutical company, (v) the expectation that
telaprevir dosing in the REALIZE trial will be complete in May 2009,
(vi) the expectation that a complete analysis of the C208 study will be
performed upon the conclusion of the study, and the Company's belief
that data obtained to date from the C208 study supports potential to
continue developing telaprevir as a twice-daily dosing regimen, (vii)
the expectation that PROVE 3 data and data from other clinical trials of
telaprevir and VCH-222 will be presented at EASL, (viii) the expected
clinical trial design for the multi-dose 3-day viral kinetic study of
VCH-222, and the potential for the results of this study to inform the
design of the first STAT-C combination trial with telaprevir, (ix) the
expected clinical trial designs for the registration program for VX-770,
(x) the clinical trial design of the Phase 2a study of VX-809 and the
expected completion of this Phase 2a study in early 2010, (xi) the broad
potential VX-509 may have for the treatment of multiple immune-mediated
inflammatory diseases and the Company entering a period of advance
licensing discussions with several collaborators to balance its
portfolio and focus R&D investments, (xii) the Company's statements
regarding its financial position, and (xiii) guidance that the Company's
projected GAAP and non-GAAP 2009 annual loss and year-end cash, cash
equivalents and marketable securities balances will be within the ranges
stated under the heading "Full Year 2009 Financial Guidance". While the
Company believes the forward-looking statements contained in this press
release are accurate, there are a number of factors that could cause
actual events or results to differ materially from those indicated by
such forward-looking statements. Those risks and uncertainties include,
among other things, that the outcomes for each of its planned clinical
trials and studies, and in particular its planned clinical trials of
telaprevir, may not be favorable, that regulatory authorities may
require supplemental clinical trials in order to support registration of
telaprevir in any particular indication, that there may be varying
interpretations of data produced by one or more of our clinical trials,
that enrollment may be more difficult or slower than we currently
anticipate or that planned clinical trials may not start when planned
due to regulatory issues, site startup delays, availability of clinical
trial material or other reasons, that regulatory authorities will
require more extensive data for a telaprevir NDA filing than currently
expected, the possibility that the Company may not be able to
successfully develop combination therapies involving telaprevir and drug
candidates acquired from ViroChem and that data from early clinical
trials of VCH-222 and VCH-759 may not be predictive of results from
future clinical trials of these polymerase inhibitors, that one or more
of the Company's assumptions underlying its revenue expectations --
including clinical and scientific progress that could lead to payments
under new collaborations -- or its expense expectations -- including
estimates of the variables that go into determining stock-based
compensation expenses -- will not be realized, or that Vertex will be
unable to realize one or more of its financial objectives for 2009 due
to unexpected and costly program delays or any number of other
financial, technical or collaboration considerations, that unexpected
costs associated with one or more of the Company's programs will
necessitate a reduction in its investment in other programs or a change
in the Company's financial projections, that future competitive or other
market factors may adversely affect the commercial potential for the
Company's product candidates in HCV or other potential indications, that
due to scientific, medical or technical developments, the Company's drug
discovery efforts will not ultimately result in commercial products or
assets that can generate revenue, that we will be unable to enter into
new collaborative relationships on acceptable terms, and other risks
listed under Risk Factors in Vertex's annual report and quarterly
reports filed with the Securities and Exchange Commission and available
through the Company's website at www.vrtx.com.
We disclaim any obligation to update the information contained in this
press release as new information becomes available.
Vertex Pharmaceuticals Incorporated
2009 First Quarter Results
Consolidated Statements of Operations Data
(In thousands, except per share amounts)
(Unaudited)
Three Months Ended
March 31,
2009 2008
Revenues:
Royalty revenues (Note 6) $ 6,140 $ 10,851
Collaborative and other R&D revenues 18,631 30,824
Total revenues 24,771 41,675
Costs and expenses:
Royalty expenses (Note 6) 3,576 3,576
Research and development expenses (R&D) (Note 7) 143,581 116,273
Sales, general & administrative expenses (SG&A) (Note 7) 28,130 19,932
Restructuring expense (Note 3) 2,402 630
Acquisition related expenses (Note 1) 7,793 -
Total costs and expenses 185,482 140,411
Loss from operations (160,711 ) (98,736 )
Net interest income (expense) (779 ) 2,582
Net loss $ (161,490 ) $ (96,154 )
Basic and diluted net loss per common share $ (1.04 ) $ (0.72 )
Basic and diluted weighted-average number of common shares 155,860 134,471
outstanding
Non-GAAP Loss and Loss per Common Share Reconciliation Three Months Ended
March 31,
2009 2008
GAAP Net Loss $ (161,490 ) $ (96,154 )
Pro Forma Adjustments:
Stock-based compensation and executive transition expenses $ 18,573 $ 10,710
included in R&D (Notes 2 & 7):
Stock-based compensation and executive transition expenses 5,205 2,362
included in SG&A (Notes 2 & 7):
Total stock-based compensation and executive transition expenses 23,778 13,072
Restructuring expense (Note 3) 2,402 630
Acquisition related expenses (Note 1) 7,793 --
Non-GAAP Loss $ (127,517 ) $ (82,452 )
Basic and diluted non-GAAP loss per common share $ (0.82 ) $ (0.61 )
Note 1: On March 12, 2009, the Company acquired ViroChem Pharma
Inc. ("ViroChem"), a biotechnology company based in Canada. The Company
paid an aggregate purchase price of $100.0 million in cash and
10,733,527 shares of the Company's common stock in order to acquire
ViroChem. The transaction will be accounted for under the acquisition
method of accounting in accordance with Financial Accounting Standards
Board ("FASB") Statement No. 141(R), "Business
Combinations" ("SFAS 141(R)"). Under SFAS 141(R), all of the assets
acquired and liabilities assumed in the transaction are recognized at
their acquisition date fair values, while transaction costs and
restructuring costs associated with the transaction are expensed as
incurred.
The $390.6 million purchase price for ViroChem is based on the
acquisition-date fair value of the consideration transferred, which was
calculated based on the opening price of the Company's common stock of
$27.07 per share on March 12, 2009. The excess of the aggregate purchase
price over the fair value of assets acquired and liabilities assumed, if
any, will be allocated to goodwill. For the purposes of the condensed
consolidated balance sheets, the Company has made preliminary
allocations of the purchase price to the tangible and intangible assets
that were acquired and to goodwill, but the Company is in the process of
obtaining third-party valuations of certain intangible assets. The final
allocations of the purchase price to intangible assets and goodwill may
differ materially from the information presented in these unaudited
condensed consolidated financial statements.
Note 2: For the three months ended March 31, 2009, the Company
incurred $23.8 million in stock-based compensation and executive
transition expenses of which $18.6 million is included in research and
development expenses and $5.2 million is included in sales, general and
administrative expenses. For the three months ended March 31, 2008, the
Company incurred $13.1 million in stock-based compensation expense of
which $10.7 million is included in research and development expenses and
$2.4 million is included in sales, general and administrative expenses.
Note 3: For the three months ended March 31, 2009, the Company
incurred restructuring expense of $2.4 million. The expense is
the result of incremental lease obligations related to the revision of
certain key estimates and assumptions about building operating costs as
well as the imputed interest cost related to the restructuring
liability. For the three months ended March 31, 2008, the Company
incurred restructuring expense of $0.6 million. The expense is
primarily a result of the imputed interest cost related to the
restructuring liability. The expense and the related liability have been
estimated in accordance with FASB Statement No. 146, "Accounting for
Costs Associated with Exit or Disposal Activities," and are reviewed
quarterly for changes in circumstances.
Note 4: In February 2009, the Company completed a public offering
of 10,000,000 shares of common stock, at a price of $32.00 per share.
This transaction resulted in net proceeds of $313.3 million to the
Company. The net proceeds include an underwriting discount of $6.4
million and other expenses of $0.4 million related to the equity
offering that were recorded as an offset to additional paid-in-capital.
In February 2008, the Company completed a public offering of 6,900,000
shares of common stock, including the underwriters' over-allotment of
900,000 shares, at a price of $17.14 per share. This transaction
resulted in net proceeds of $112.7 million to the Company. The net
proceeds include an underwriting discount of $5.3 million and other
expenses of $0.2 million related to the offering that were recorded as
an offset to additional paid-in-capital.
Note 5: In February 2008, the Company completed an offering of
$287.5 million aggregate principal amount of 4.75% convertible senior
subordinated notes due February 2013 (the "2013 Notes"), including $37.5
million aggregate principal amount of notes purchased by the
underwriters pursuant to their over-allotment option. The 2013 Notes are
convertible, at the option of the holder, into common stock at a price
equal to approximately $23.14 per share, subject to adjustment under
certain circumstances. The 2013 Notes bear interest at the rate of 4.75%
per year, and the Company is required to make semi-annual interest
payments on the outstanding principal balance of the notes on
February 15 and August 15 of each year. This transaction resulted in net
proceeds of $278.6 million to the Company. The net proceeds include an
underwriting discount of $8.6 million and other expenses of $0.3 million
related to the offering that were recorded as deferred issuance costs
and are in included in other assets on the Company's condensed
consolidated balance sheets.
Note 6: In the first quarter of 2008, the Company recognized
royalty revenues based on actual and estimated net sales of
Lexiva/Telzir and Agenerase by GlaxoSmithKline plc under the Company's
1993 license agreement with GlaxoSmithKline plc. In the second quarter
of 2008, the Company sold the Company's right to receive future royalty
payments, net of sub-royalty payments due to a third party, arising from
sales of Lexiva/Telzir and Agenerase under the Company's license
agreement with GlaxoSmithKline plc in return for a one-time cash payment
of $160.0 million. In accordance with Emerging Issues Task Force Issue
No.88-18, "Sales of Future Revenues," in the first quarter of 2009 the
Company recognized deferred revenues relating to the $160.0 million
one-time cash payment from the purchaser under the "units-of-revenue"
method.
Note 7: Certain amounts in prior year's financial statements have
been reclassified to conform to the current presentation. The
reclassifications had no effect on the reported net loss.
Condensed Consolidated Balance Sheets Data
(In thousands)
(Unaudited)
March 31, December 31,
2009 2008
Assets
Cash, cash equivalents and marketable securities $ 869,186 $ 832,101
Other current assets 33,779 35,480
Property and equipment, net 66,601 68,331
Restricted cash 30,258 30,258
Intangible assets/goodwill (Note 1) 559,775 --
Other non-current assets (Notes 5 & 6) 14,068 14,309
Total assets $ 1,573,667 $ 980,479
Liabilities and Stockholders' Equity
Other current liabilities $ 134,666 $ 172,567
Accrued restructuring expense 34,811 34,064
Deferred tax liability (Note 1) 161,600 --
Deferred revenues (Note 6) 239,162 247,474
Convertible notes (due 2013)(Note 5) 287,500 287,500
Stockholders' equity (Notes 1 & 4) 715,928 238,874
Total liabilities and stockholders' equity $ 1,573,667 $ 980,479
Common shares outstanding(Notes 1 & 4) 172,986 151,245
Conference Call and Webcast: First Quarter Financial Results:
Vertex Pharmaceuticals will host a conference call and webcast today,
Thursday, April 16, 2009 at 5:00 p.m. EDT to review financial results
and recent developments. This call and webcast will be broadcast via the
Internet at www.vrtx.com.
It is suggested that webcast participants go to the web site at least 10
minutes in advance of the call to ensure that they can access the
slides. The link to the webcast is available on the Events and
Presentations button on the home page.
To listen to the call on the telephone, dial (800) 374-0296 (U.S. and
Canada) or (702) 696-4937 (International). Vertex is also providing a
podcast MP3 file available for download on the Vertex website at www.vrtx.com.
The call will be available for replay via telephone commencing April 16,
2009 at 8:00 p.m. EDT running through 5:00 p.m. EDT on April 23, 2009.
The replay phone number for the U.S. and Canada is (800) 642-1687. The
international replay number is (706) 645-9291 and the conference ID
number is 93307512. Following the live webcast, an archived version will
be available on Vertex's website until 5:00 p.m. EDT on April 30, 2009.
Vertex's press releases are available at www.vrtx.com.
(VRTX-GEN)
SOURCE: Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
Investors
Michael Partridge, 617-444-6108
or
Lora Pike, 617-444-6755
or
Media
Jane A. Kramer, 617-444-6924
or
Zachry Barber, 617-444-6470
For full details on Vertex Pharmaceuticals (VRTX) VRTX. Vertex Pharmaceuticals (VRTX) has Short Term PowerRatings at TradingMarkets. Details on Vertex Pharmaceuticals (VRTX) Short Term PowerRatings is available at This Link.
- SmarTrend research report available on Vertex Pharmaceuticals (NASDAQ:VRTX) - 02/08/10
- Vertex Pharmaceuticals Reports 2009 Financial Results and Highlights Recent Progress in Hepatitis C and Cystic Fibrosis Developm - 02/04/10
- Vertex Pharmaceuticals Bearish Moving Average Crossover Alert (VRTX) - 02/04/10
- BiomedReports: News and FDA Updates for Seattle Genetics (Nasdaq:SGEN), Vertex (Nasdaq:VRTX), Vystar (OTC:VYST) - 02/04/10
- Conference Calls Today: 5 P.M. EST - 02/04/10
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