- Telaprevir Phase 3 registration program in hepatitis C on track;
NDA submission anticipated in second half of 2010 -
- Vertex advancing two drug candidates aimed at the underlying
disease mechanism of the orphan disorder cystic fibrosis -
- Vertex ends second quarter with $754 million of cash, cash
equivalents and marketable securities; Vertex will add to this position
with $105 million of cash through an amended agreement with Mitsubishi
Tanabe Pharma Corporation -
Vertex
Pharmaceuticals Incorporated (Nasdaq: VRTX) today reviewed recent
business and clinical progress and reported consolidated financial
results for the quarter ended June 30, 2009.
“Our top priority is to execute on the telaprevir Phase 3 registration
program in hepatitis C and to prepare for a New Drug Application
submission in the second half of 2010,” said Matthew Emmens, Chairman,
President and Chief Executive Officer of Vertex Pharmaceuticals. “Beyond
HCV, we are now conducting a comprehensive program in cystic fibrosis -
a life-threatening orphan disorder - with two novel therapies that
target the underlying disease mechanism. With the advancement of our
pipeline and continued research productivity, we are moving closer to
fulfilling our corporate vision of building a profitable, fully-capable
biopharmaceutical company focused on improving patient outcomes in areas
of serious unmet medical need.”
Mr. Emmens continued, "Vertex enters the second half of 2009 in a strong
financial position that will enable continued investment into late-stage
development opportunities for HCV and CF and into product creation from
research. We continue to closely manage our cash investment in the
Company and will add $105 million to our financial position through an
amended agreement with Mitsubishi Tanabe for the development and
commercialization of telaprevir in Asia.”
Broad Commitment to Hepatitis C
Telaprevir Phase 3 registration program on track
Treatment-naïve Phase 3 trials
-
Vertex is conducting the Phase 3 ADVANCE study, which is evaluating
the hepatitis C virus (HCV) protease inhibitor telaprevir, or placebo,
as part of a 24-week combination regimen with pegylated interferon
(peg-IFN) and ribavirin (RBV) in more than 1,050 genotype 1
treatment-naïve HCV patients. Based upon the completion of enrollment
in October 2008, the telaprevir dosing portion of the ADVANCE trial is
complete, and all patients are now beyond week 24 of the study.
Patients receiving telaprevir-based regimens in the ADVANCE study will
receive 24 or 48 weeks of total therapy, depending on whether they
have undetectable virus levels at weeks 4 and 12 of treatment. The
ADVANCE trial will remain blinded through the last patient completing
week 72 in the study. The Company expects sustained viral response
(SVR) 24 data to become available from ADVANCE in the first half of
2010.
-
Vertex is also conducting ILLUMINATE, a global two-arm trial that is
evaluating response-guided telaprevir-based regimens in approximately
500 genotype 1 treatment-naïve HCV patients. This trial is designed to
supplement 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-naïve patients who achieved undetectable virus levels at
weeks 4 and 12 of treatment (eRVR). Based upon the completion of
enrollment in January 2009, the telaprevir dosing portion of the
ILLUMINATE trial is complete, and all patients are now beyond week 24
of the study. The Company expects SVR24 data to become available from
ILLUMINATE in the first half of 2010.
Treatment-failure Phase 3 trial
-
Vertex’s collaborator 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 did not achieve an SVR with
a previous peg-IFN-based treatment, and which enrolled all major
treatment-failure groups including null responders. Based upon the
completion of enrollment in February 2009, the telaprevir dosing
portion of the REALIZE trial is complete, and all patients are now
beyond week 20 of the study. The Company expects SVR24 data to become
available from REALIZE in mid-2010.
Telaprevir twice-daily evaluation
-
Vertex expects that final SVR24 data from Study C208, which is
evaluating twice-daily telaprevir dosing, will be presented at a
Presidential Plenary session at the upcoming Annual Meeting of the
American Association for the Study of Liver Diseases (AASLD), Oct. 30
- Nov. 3 in Boston. Study C208 is a Phase 2, open-label clinical study
being conducted by Tibotec in Europe that is evaluating a twice-daily
(1125mg q12h) dosing schedule of telaprevir in combination with
peg-IFN-alfa-2a (PEGASYS®) or peg-IFN-alfa-2b (PEGINTRON™)
and RBV, as compared to the current three-times-daily (750mg q8h)
telaprevir dosing schedule. All dosing of study medications was
completed in Study C208 in April. Patients are now in the
post-treatment follow-up phase to determine the number of patients who
achieve an SVR24 with twice-daily compared to three-times-daily dosing
of telaprevir.
Additional telaprevir clinical studies
-
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 from PROVE 3 have been provided to the U.S. Food and Drug
Administration.
-
All patients in Study 107, an open-label Phase 2 study to evaluate
telaprevir-based combination regimens in patients who did not achieve
an SVR in the 48-week control arms of the Phase 2 PROVE studies, have
completed 24 weeks of dosing. In the study, telaprevir was given in
combination with peg-IFN and RBV for 12 weeks followed by peg-IFN and
RBV for 12 weeks or 36 weeks depending on the patient’s antiviral
response to telaprevir in Study 107 and whether the patient was a
prior non-responder, partial-responder or relapser. Vertex anticipates
that additional data, including SVR24 data, from Study 107 will become
available in 2010.
STAT-C combination therapies
-
Vertex is seeking to advance HCV therapy through the development of
novel combinations of Specifically-Targeted Antiviral Therapies for
hepatitis C (STAT-Cs). The Company plans to begin a combination trial
of telaprevir with the HCV polymerase inhibitor VX-222 (formerly
VCH-222) in patients with genotype 1 HCV as early as the fourth
quarter of 2009.
-
Vertex expects data from this first STAT-C combination study to become
available in the first half of 2010.
-
Vertex is currently conducting a three-day, multiple-dose viral
kinetic study to evaluate the antiviral activity, safety, tolerability
and pharmacokinetics of VX-222 dosed as a monotherapy in 32
treatment-naïve patients with genotype 1 HCV infection. This study is
scheduled for completion in the third quarter of 2009. Additionally,
Vertex expects to initiate a drug-drug interaction study with VX-222
and telaprevir in healthy volunteers in the third quarter of 2009.
Additional HCV compounds in clinical development
-
Vertex is conducting early-stage development activities with novel HCV
compounds, including the additional HCV protease inhibitors VX-813 and
VX-985 as well as the HCV polymerase inhibitor VX-759 (formerly
VCH-759). Vertex also has an NS5A inhibitor program in preclinical
development. The goal of these programs is to identify compounds that
are appropriate for further development, including combination therapy.
AASLD
-
Three abstracts related to telaprevir have been accepted for
presentation at AASLD, Oct. 30 - Nov. 3 in Boston, including an
abstract representing Study C208. Study C208 is evaluating twice-daily
dosing of telaprevir and will be presented at AASLD as part of an oral
Presidential Plenary session on November 3.
Broad Program Targeting Cystic Fibrosis
Potentiator compound VX-770 in Phase 3 registration program
-
In May, Vertex initiated the Phase 3 ENDEAVOR 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 consists of three
separate trials designed to evaluate the utility of VX-770 across
different age groups and genotypes, including children as young as six
years of age.
-
The Phase 3 STRIVE trial is designed to enroll a minimum of 80
patients aged 12 and older who carry the G551D mutation on at least
one allele. Patients will receive either VX-770 or placebo for 48
weeks in the STRIVE trial. Vertex initiated the STRIVE trial in May.
The Company expects to complete enrollment in STRIVE in the first
quarter of 2010.
-
The Phase 3 ENVISION trial is a two-part trial of VX-770 in patients
with CF aged 6 to 11 years with the G551D mutation on at least one
allele. Vertex announced today that it has initiated Part 1 of the
ENVISION trial. Part 1 of the trial is a single-dose pharmacokinetic
study that is expected to enroll approximately 10 patients. Part 2 of
the trial is expected to enroll approximately 30 patients who will
receive either VX-770 or placebo for 48 weeks.
-
The Phase 2 DISCOVER trial is an exploratory trial designed to enroll
approximately 120 patients aged 12 years and older who are homozygous
for the F508del mutation. Patients will receive either VX-770 or
placebo for 16 weeks. Vertex expects to initiate the DISCOVER trial in
the third quarter of 2009.
-
The primary endpoint for patients with the G551D mutation (STRIVE and
ENVISION trials) is change in forced expiratory volume in one second
(FEV1), which will be measured at 24 weeks.
Additional FEV1 measurements will be taken at 48 weeks as a
secondary endpoint to assess durability of any observed response.
Patients in the STRIVE and ENVISION trials will receive either VX-770
or placebo for 48 weeks to gain additional safety data in G551D
patients. For patients with the F508del mutations (DISCOVER trial),
the primary endpoints are safety and change in FEV1, which
will be measured at 16 weeks. Additional secondary endpoints,
including sweat chloride, will be measured in each trial to evaluate
the effect of VX-770 on improving the function of the defective CFTR
protein.
Corrector compound VX-809 in Phase 2a trial
-
Vertex is conducting 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 homozygous for the F508del CFTR mutation,
the most common mutation in patients with CF. In addition to safety,
the trial provides the first opportunity to evaluate the potential
effect of VX-809 on measures of CFTR function, including sweat
chloride and nasal potential difference. The trial will also evaluate
whether VX-809 has an effect on FEV1. The trial is expected
to be complete in early 2010.
Additional Pipeline Progress – VX-509 (JAK3 inhibitor)
-
Vertex has advanced VX-509, a highly selective inhibitor of Janus
kinase 3 (JAK3), through Phase 1 clinical development.
-
In in vitro studies, VX-509 has been shown to be greater than
1000-fold more selective for JAK3 compared to non-JAK kinases and
approximately 25- to 150-fold more selective for JAK3 compared to
other JAK isotypes in cell-based assays.
-
Results of a Phase 1, 14-day dose-ranging study of VX-509 in healthy
volunteers completed in the first quarter suggested a promising safety
profile. In addition, VX-509 showed a profound dose-dependent and
reversible reduction in PSTAT-5, a specific biomarker of JAK3
activity, and a high degree of selectivity for JAK3 over JAK2,
consistent with observations from previous in vitro studies.
-
VX-509 may have broad potential for the treatment of multiple
immune-mediated inflammatory diseases.
Recent Business Development Activities - Amended Agreement with
Mitsubishi Tanabe
-
In July, Vertex and Mitsubishi Tanabe Pharma Corporation amended their
agreement for the development and commercialization of telaprevir in
Japan and certain Far East countries. Under the terms of the amended
agreement, Vertex will receive $105 million following signing, and
will be eligible to receive further milestones upon approval and
commercialization in Japan.
Second Quarter Results
For the quarter ended June 30, 2009, the Company’s GAAP net loss was
$171.3 million, or $0.99 per share, including stock-based compensation
and executive transition expenses of $28.6 million, restructuring
expenses of $1.1 million, and loss on exchange of convertible
subordinated notes of $12.3 million, compared to a GAAP net loss for the
quarter ended June 30, 2008 of $91.3 million, or $0.66 per share,
including stock-based compensation expense of $16.6 million and
restructuring expenses of $1.2 million.
The non-GAAP loss, before stock-based compensation and executive
transition expenses, restructuring expenses, and loss on exchange of
convertible subordinated notes, for the quarter ended June 30, 2009 was
$129.3 million, or $0.75 per share, compared to $73.6 million, or $0.53
per share, for the quarter ended June 30, 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 initiation of the VX-770 Phase 3 registration
program.
Total revenues for the quarter ended June 30, 2009 were $19.1 million,
compared to $69.4 million for the second quarter of 2008. The second
quarter 2008 revenues included an R&D milestone of $45.0 million that
did not recur in 2009.
Research and development (R&D) expenses for the quarter ended June 30,
2009 were $139.3 million, compared to $129.6 million for the second
quarter of 2008. The increase primarily reflects investment activity to
support advancement of Phase 3 trials for telaprevir as well as
initiation of the Phase 3 registration program for VX-770.
Sales, general and administrative (SG&A) expenses for the quarter ended
June 30, 2009 were $32.5 million, compared to $26.4 million for the
second 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 toward potential
launch.
Interest expense, net, for the quarter ended June 30, 2009 was $1.8
million, compared to interest income, net, of $0.2 million for the
second quarter of 2008. This decrease resulted primarily from a lower
level of investment portfolio yields reflecting the broader economic
environment.
At June 30, 2009, Vertex had $754.4 million in cash, cash equivalents
and marketable securities. Additionally, following the recent exchange
of $143.5 million of 2013 convertible senior subordinated notes for
common stock, the Company now has $144.0 million of remaining 2013 notes
at a conversion price of $23.14 per share.
Vertex will receive approximately $105 million of cash as a result of an
amended agreement with Mitsubishi Tanabe for the development and
commercialization of telaprevir in Asia, which puts the Company’s pro
forma cash, cash equivalents and marketable securities position above
$850 million as of June 30, 2009.
Full Year 2009 Financial Guidance
This section contains forward-looking guidance about the financial
outlook for Vertex Pharmaceuticals.
The Company is today reiterating its guidance for 2009 year-end cash,
cash equivalents and marketable securities of approximately $700
million. Vertex is also reiterating its guidance for 2009 non-GAAP loss
of $400 to $435 million, which assumes the successful completion of
additional business development and outlicensing activities that may
further add to the Company’s year-end cash, cash equivalents and
marketable securities position. The Company is updating its guidance for
2009 GAAP loss to approximately $515 to $550 million.
“Vertex remains focused on its capital structure and maintaining a
strong cash position while managing its investment through to an
anticipated cashflow positive business following the potential launch of
our late-stage products," said Ian Smith, Executive Vice President and
Chief Financial Officer of Vertex. "Following the recently amended
agreement with Mitsubishi Tanabe, we are positioned with pro forma cash,
cash equivalents and marketable securities in excess of $850 million as
of June 30, 2009. We believe our financial position continues to support
the advancement of late-stage development programs and investment in
product creation from research, and we continue to consider further
business transactions that may provide additional sources of capital in
2009.
“In addition, in the second quarter we completed a private exchange of
$143.5 million in convertible notes for common stock, further reducing
our near-term debt obligations as we advance toward the launch of
telaprevir,” Mr. Smith added.
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 (i) provides its second quarter 2009 and 2008 loss,
and guidance for its projected 2009 loss, excluding restructuring
expense, acquisition-related expenses, executive transition expenses,
stock-based compensation expense, and loss on exchange of convertible
subordinated notes, and (ii) references its cash, cash equivalents and
marketable securities position on a pro forma basis as of June 30, 2009,
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, are important
in comparing current results with prior period results and provide
additional information regarding its financial position. 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. The
pro forma cash, cash equivalents and marketable securities in excess of
$850 million represents Vertex’s cash, cash equivalents and marketable
securities balance of $754.4 million on June 30, 2009 plus the $105.0
million Vertex expects to receive from Mitsubishi Tanabe following
signing. A reconciliation of the other 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® is a registered trademark of Hoffman La Roche.
PEGINTRON™ is a trademark of Schering Corporation.
Special Note Regarding Forward-looking Statements
This press release contains forward-looking statements, including
statements regarding (i) the anticipated submission of an NDA for
telaprevir in the second half of 2010, (ii) the advancement of two drug
candidates aimed at the underlying mechanism of the orphan disorder
cystic fibrosis, (iii) moving closer to fulfilling the Company’s
corporate vision of building a profitable, fully-capable
biopharmaceutical company focused on improving patient outcomes in areas
of serious unmet medical need, (iv) the Company’s strong financial
position enabling the continued investment into late-stage development
opportunities for HCV and CF and into product creation from research,
(v) the Company’s expectations regarding when sustained viral response
data will be available from its ADVANCE, ILLUMINATE and REALIZE clinical
trials, (vi) the aim of the ILLUMINATE clinical trial being to
characterize whether there is an additional benefit to extending
treatment from 24 weeks to 48 weeks in treatment-naïve patients who
achieve eRVR, (vii) the expectation that additional data, including
final sustained viral response data, from Study C208 will be presented
at AASLD, (viii) the expectation that additional data, including SVR24
data, from Study 107 will become available in 2010, (ix) the plan to
begin a combination trial of telaprevir with VX-222 as early as the
fourth quarter of 2009 and the expectation that data from this study
will become available in the first half of 2010, (x) the scheduled
completion of the 3-day VX-222 clinical trial in the third quarter of
2009 and the expectation that the Company will initiate a drug-drug
interaction study with VX-222 and telaprevir in the third quarter of
2009, (xi) seeking to advance HCV therapy through the development of
novel STAT-C combinations and to identify compounds through the
Company’s early-stage development activities that are appropriate for
further development, (xii) the ENDEAVOR registration program being
designed to evaluate the utility of VX-770 across different age groups
and genotypes, (xiii) the clinical trial designs, including expected
numbers of patients, primary and secondary endpoints and the treatment
durations, for the STRIVE, ENVISION and DISCOVER clinical trials, (xiv)
the expectation that STRIVE will complete enrollment in the first
quarter of 2010 and that the DISCOVER trial will be initiated in the
third quarter of 2009, (xv) the expectation that the Phase 2a clinical
trial of VX-809 will be complete in early 2010, (xvi) the results of the
Phase 1 dose-ranging study of VX-509 suggesting a promising safety
profile, showing a profound dose-dependent and reversible reduction in a
biomarker of JAK3 activity and a high degree of selectivity for JAK3
over JAK2, (xvii) the possibility that VX-509 may have broad potential
for the treatment of multiple immune-mediated inflammatory diseases,
(xviii) the expectation that the Company will receive $105 million from
Mitsubishi Tanabe and the eligibility for the Company to receive further
milestones from Mitsubishi Tanabe, (xix) 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,” (xx) the
focus on capital structure and maintaining a strong cash position while
managing investment through to an anticipated cashflow positive business
following the potential launch of late-stage products, and (xxi) the
consideration of further business transactions that may provide
additional sources of capital in 2009. 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, that regulatory authorities
will require more extensive data for a telaprevir NDA filing than
currently expected, that the Company may not be able to successfully
develop combination therapies involving telaprevir and VX-222, that the
Company may not complete additional business development and
outlicensing activities, 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 the Company 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 the Company 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.
The Company disclaims any obligation to update the information contained
in this press release as new information becomes available.
|
|
|
|
|
|
|
|
|
|
|
|
|
Vertex Pharmaceuticals Incorporated
2009 Second Quarter and Six Month Results
Consolidated Statements of Operations Data
(in thousands, except per share amounts)
(unaudited)
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
Royalty revenues (Note 6)
|
|
$5,917
|
|
|
$9,741
|
|
|
$12,057
|
|
|
$20,592
|
|
|
Collaborative and other R&D revenues
|
|
13,147
|
|
|
59,668
|
|
|
30,986
|
|
|
90,492
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
19,064
|
|
|
69,409
|
|
|
43,043
|
|
|
111,084
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
Royalty expenses (Note 6)
|
|
3,267
|
|
|
3,701
|
|
|
6,843
|
|
|
7,277
|
|
|
Research and development expenses (R&D) (Note 7)
|
|
139,331
|
|
|
129,573
|
|
|
282,912
|
|
|
245,846
|
|
|
Sales, general & administrative expenses (SG&A) (Note 7)
|
|
32,526
|
|
|
26,448
|
|
|
61,046
|
|
|
46,380
|
|
|
Restructuring expense (Note 3)
|
|
1,107
|
|
|
1,168
|
|
|
3,509
|
|
|
1,798
|
|
|
Acquisition-related expenses (Note 1)
|
|
---
|
|
|
---
|
|
|
7,793
|
|
|
---
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses
|
|
176,231
|
|
|
160,890
|
|
|
362,103
|
|
|
301,301
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
(157,167
|
)
|
|
(91,481
|
)
|
|
(319,060
|
)
|
|
(190,217
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net interest income (expense) (Note 5)
|
|
(1,836
|
)
|
|
160
|
|
|
(2,615
|
)
|
|
2,742
|
|
|
Loss on exchange of convertible subordinated notes (Note 5)
|
|
(12,294
|
)
|
|
---
|
|
|
(12,294
|
)
|
|
---
|
|
|
Net loss
|
|
$ (171,297
|
)
|
|
$ (91,321
|
)
|
|
$ (333,969
|
)
|
|
$ (187,475
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share
|
|
$ (0.99
|
)
|
|
$ (0.66
|
)
|
|
$ (2.03
|
)
|
|
$ (1.37
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted weighted-average number of common shares
outstanding
|
|
172,563
|
|
|
138,725
|
|
|
164,258
|
|
|
136,607
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Loss and Loss per Common Share Reconciliation
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
|
GAAP Net Loss
|
|
$ (171,297
|
)
|
|
$ (91,321
|
)
|
|
$ (333,969
|
)
|
|
$ (187,475
|
)
|
|
Pro Forma Adjustments:
|
|
|
|
|
|
|
|
|
|
Stock-based compensation and executive transition expenses
included in R&D (Notes 2 & 7):
|
|
$22,162
|
|
|
$13,259
|
|
|
$40,735
|
|
|
$23,969
|
|
|
Stock-based compensation and executive transition expenses
included in SG&A (Notes 2 & 7)
|
|
6,415
|
|
|
3,334
|
|
|
11,620
|
|
|
5,696
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stock-based compensation and executive transition expenses
|
|
$28,577
|
|
|
$16,593
|
|
|
$52,355
|
|
|
$29,665
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss on exchange of convertible
subordinated notes (Note 5)
|
|
12,294
|
|
|
---
|
|
|
12,294
|
|
|
---
|
|
|
Restructuring expense (Note 3)
|
|
1,107
|
|
|
1,168
|
|
|
3,509
|
|
|
1,798
|
|
|
Acquisition-related expenses (Note 1)
|
|
---
|
|
|
---
|
|
|
7,793
|
|
|
---
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Loss
|
|
$ (129,319
|
)
|
|
$ (73,560
|
)
|
|
$ (258,018
|
)
|
|
$ (156,012
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted non-GAAP loss per common share
|
|
$ (0.75
|
)
|
|
$ (0.53
|
)
|
|
$ (1.57
|
)
|
|
$ (1.14
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 is being 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 difference between the aggregate
purchase price and the fair value of assets acquired and liabilities
assumed was allocated to goodwill.
Note 2: For the three and six months ended June 30, 2009, the
Company incurred $28.6 million and $52.4 million, respectively, in
stock-based compensation and executive transition expenses of which
$22.2 million and $40.7 million, respectively, is included in research
and development expenses and $6.4 million and $11.6 million,
respectively, is included in sales, general and administrative expenses.
For the three and six months ended June 30, 2008, the Company incurred
$16.6 million and $29.7 million, respectively, in stock-based
compensation expense of which $13.3 million and $24.0 million,
respectively, is included in research and development expenses and $3.3
million and $5.7 million, respectively, is included in sales, general
and administrative expenses.
Note 3: The Company recorded restructuring expense of $1.1
million for the three months ended June 30, 2009 compared to $1.2
million for the three months ended June 30, 2008. The Company recorded
restructuring expense of $3.5 million for the six months ended June 30,
2009 compared to $1.8 million for the six months ended June 30, 2008.
The restructuring expense in all periods included imputed interest cost
related to the restructuring liability. The increase in restructuring
expense for the six months ended June 30, 2009 compared to the six
months ended June 30, 2008 was primarily the result of a revision, in
the first quarter of 2009, of certain key estimates and assumptions
about facility operating costs for the remaining period of the lease
commitment, for which there was no corresponding revision in the six
months ended June 30, 2008. The lease restructuring liability was $34.1
million as of June 30, 2009. 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.
In September 2008, the Company completed a public offering of 8,625,000
shares of common stock, at a price of $25.50 per share. This transaction
resulted in net proceeds of $217.4 million to the Company.
In February 2008, the Company completed a public offering of 6,900,000
shares of common stock at a price of $17.14 per share. This transaction
resulted in net proceeds of $112.7 million to the Company.
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”). 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.
In June 2009, holders of the 2013 Notes exchanged $143.5 million in
aggregate principal amount of the 2013 Notes, plus interest, for
6.6 million shares of newly issued common stock. As a result of this
exchange, the Company incurred a non-cash charge of $12.3 million in the
second quarter of 2009. The charge corresponds to the value of
additional shares issued in the transactions over the number of shares
that would have been issued upon conversion of the 2013 Notes at the
conversion prices set forth therein.
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,” after the sale of the Company’s
right to receive future royalty payments, the Company recognizes
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)
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2009
|
|
|
|
December 31,
2008
|
|
Assets
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities
|
|
$754,364
|
|
|
|
$832,101
|
|
Other current assets
|
|
28,392
|
|
|
|
35,480
|
|
Property and equipment, net
|
|
64,358
|
|
|
|
68,331
|
|
Restricted cash
|
|
30,258
|
|
|
|
30,258
|
|
Intangible assets (Note 1)
|
|
525,900
|
|
|
|
---
|
|
Goodwill (Note 1)
|
|
26,883
|
|
|
|
---
|
|
Other non-current assets (Notes 5 & 6)
|
|
9,721
|
|
|
|
14,309
|
|
Total assets
|
|
$1,439,876
|
|
|
|
$980,479
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity
|
|
|
|
|
|
|
|
Other current liabilities
|
|
$139,504
|
|
|
|
$172,567
|
|
Accrued restructuring expense (Note 3)
|
|
34,050
|
|
|
|
34,064
|
|
Deferred tax liability (Note 1)
|
|
162,503
|
|
|
|
---
|
|
Deferred revenues (Note 6)
|
|
230,762
|
|
|
|
247,474
|
|
Convertible notes (due 2013)(Note 5)
|
|
144,000
|
|
|
|
287,500
|
|
Stockholders’ equity (Notes 1, 4 & 5)
|
|
729,057
|
|
|
|
238,874
|
|
Total liabilities and stockholders’ equity
|
|
$1,439,876
|
|
|
|
$980,479
|
|
Common shares outstanding (Notes 1, 4 & 5)
|
|
180,203
|
|
|
|
151,245
|
|
|
|
|
|
|
|
|
Conference Call and Webcast: Second Quarter Financial Results:
Vertex Pharmaceuticals will host a conference call and webcast today,
Wednesday, August 5, 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 August 5,
2009 at 8:00 p.m. EDT running through 5:00 p.m. EDT on August 12, 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 21302443. Following the live webcast, an archived version will
be available on Vertex’s website until 5:00 p.m. EDT on August 19, 2009.
Vertex’s press releases are available at www.vrtx.com.
(VRTX-GEN)
Vertex Contacts:
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