Vertex
Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported
consolidated financial results for the quarter ended September 30, 2013.
Vertex reported total third quarter 2013 revenues of $222 million,
including net product revenues of $101 million from KALYDECOTM
(ivacaftor) and $86 million from INCIVEK® (telaprevir). The
GAAP net loss attributable to Vertex was $(124.1) million, or $(0.54)
per share, for the third quarter of 2013, including certain charges of
$49.7 million, comprised primarily of stock-based compensation expense
and restructuring charges. Non-GAAP net loss attributable to Vertex for
the third quarter of 2013 was $(74.4) million, or $(0.32) per diluted
share. The company reported $1.42 billion in cash, cash equivalents and
marketable securities as of September 30, 2013. The company also today
provided updated financial guidance for 2013.
Vertex also announced that it would focus its investment on future
opportunities in cystic fibrosis (CF) and other research and early
development programs, including VX-135 as part of all-oral regimens for
hepatitis C. The company is reducing its workforce related to the
support of INCIVEK following the continued and rapid decline in the
number of people being treated with INCIVEK as other new medicines for
hepatitis C near approval. These changes are expected to generate a
reduction in 2014 non-GAAP operating expenses of approximately $150
million to $200 million compared to anticipated 2013 non-GAAP operating
expenses of approximately $1.1 billion.
"Our business is at a unique point in its evolution. We have a
tremendous opportunity ahead of us to further transform the treatment of
cystic fibrosis, which continues to be the company's highest priority
development program," commented Jeffrey Leiden, M.D., Ph.D., Chairman,
President and Chief Executive Officer of Vertex. "Following the
continued decline in the number of people starting treatment with
INCIVEK, we today took the difficult step to reduce our workforce
supporting this medicine, enabling us to focus our investment on key
programs in cystic fibrosis and other diseases to position the company
for future growth."
Vertex continues to advance key development programs for the treatment
of CF and for all-oral regimens for hepatitis C and has multiple ongoing
and planned studies for these programs. The company today provided the
following updates:
Cystic Fibrosis
Vertex is conducting multiple studies aimed at helping more people with
CF and enhancing the clinical benefit for these patients with our
approved and investigational medicines. The company recently provided a
comprehensive overview of its ongoing and planned studies in CF,
including multiple ongoing label-expansion studies for ivacaftor,
ongoing and planned Phase 2 and Phase 3 combination studies of
lumacaftor (VX-809) and ivacaftor, and VX-661 and ivacaftor, and
research efforts aimed at beginning clinical development of a
next-generation corrector. The company's two Phase 3 studies evaluating
a combination of ivacaftor and lumacaftor in people with CF who have two
copies of the F508del mutation are now fully enrolled. Data from these
studies are expected in mid-2014, and Vertex plans to submit a New Drug
Application (NDA) in the U.S. and a Marketing Authorization Application
(MAA) in Europe in the second half of 2014 for the combination of
lumacaftor and ivacaftor. These and other updates were made as part of a
press release issued on October 17, 2013.
Hepatitis C
Vertex's strategy in hepatitis C is to develop new all-oral treatment
regimens of 12 weeks or less in duration with a goal of providing a high
viral cure rate and improved tolerability for multiple hepatitis C
genotypes. Vertex is conducting the following studies of VX-135, its
nucleotide analogue hepatitis C virus (HCV) polymerase inhibitor:
-
Study of VX-135 in Combination with Daclatasvir: Vertex
and Bristol Myers Squibb Company (BMS) are conducting a Phase 2 study
of VX-135 in combination with daclatasvir, an NS5A replication complex
inhibitor being developed by BMS, in New Zealand. Safety and efficacy
results from the first part of the study are expected to be available
in early 2014 to inform future development plans for this combination.
-
VX-135 in Combination with Simeprevir: A drug-drug
interaction study of VX-135 in combination with simeprevir in healthy
volunteers is complete. Simeprevir (TMC435) is a once-daily
investigational hepatitis C protease inhibitor being jointly developed
by Janssen R&D Ireland and Medivir AB. Vertex and Janssen are
currently discussing the design of additional studies of VX-135 in
combination with simeprevir in patients with genotype 1 hepatitis C.
-
Studies of VX-135 in Combination with Ribavirin: Dosing
of VX-135 in combination with ribavirin is complete in two Phase 2
studies. These studies were conducted to generate safety data for
VX-135 in combination with ribavirin and were not intended to evaluate
the combination of VX-135 and ribavirin as a therapeutic regimen.
-
Vertex recently completed a 12-week Phase 2 study of VX-135 dosed
at 100 mg and 200 mg in combination with ribavirin being conducted
in Europe. Ten patients with genotype 1 hepatitis C were enrolled
in each dose group and all 20 patients completed 12 weeks of
treatment. Both the 100 mg and 200 mg doses were well tolerated,
no serious adverse events were reported and no liver or cardiac
safety issues were identified. As previously reported, 70 percent
and 80 percent of patients in the 100 mg and 200 mg dosing arms,
respectively, had undetectable HCV RNA within four weeks of
initiating treatment. SVR12 rates were 10 percent and 50 percent
for the 100 mg and 200 mg groups, respectively. These data will be
presented as a poster at the 64th American Association
for the Study of Liver Diseases Annual Meeting (AASLD), November
1-5, 2013 in Washington, D.C.
-
Dosing of 100 mg of VX-135 in combination with ribavirin as part
of a 12-week Phase 2 study in the United States is complete. Ten
patients with genotype 1 hepatitis C were enrolled in this dose
group, and all 10 patients completed 12 weeks of treatment. The
100 mg dose was well tolerated, no serious adverse events were
reported and no liver or cardiac safety issues were identified.
All patients achieved undetectable HCV RNA during the 12-week
dosing period, and 60 percent of patients had undetectable HCV RNA
within four weeks of initiating treatment. The SVR4 rate was 10
percent.
-
Further evaluation of VX-135 in the U.S. is subject to resolution
with the FDA regarding the partial clinical hold on VX-135. The
company intends to provide further data to the FDA, including SVR
data from ongoing studies of VX-135 dosed at 100 mg and 200 mg in
combination with ribavirin and with daclatasvir, through the first
quarter of 2014.
Autoimmune Diseases
Vertex's strategy in autoimmune diseases is to maximize the value of
VX-509, an investigational oral, selective Janus kinase 3 (JAK3)
inhibitor, across multiple autoimmune diseases globally. Vertex is
actively pursuing collaborative opportunities to support further global
development of VX-509. In a press release issued on October 18, 2013,
Vertex announced 12-week results from an ongoing Phase 2b study of
VX-509 dosed once or twice daily in people with active rheumatoid
arthritis (RA) taking methotrexate. The study met its primary endpoints
of both the proportion of people who achieved at least a 20 percent
improvement in signs and symptoms of RA, as measured by the ACR
improvement criteria (ACR20), and the change from baseline in Disease
Activity Score for 28 joints (DAS28). These results were accepted for
presentation at the ACR annual meeting, being held October 25-30 in San
Diego, CA. The presentation of the results will take place today in the
"ACR Late-Breaking Abstract Oral Session" from 2:30 to 4:00 p.m. PT.
Workforce Reduction and Investment Focus on
Future Opportunities in Cystic Fibrosis and Other Key Research and
Development Programs
As part of a reduction in Vertex's global workforce and the resulting
investment focus on future opportunities in cystic fibrosis and other
high-potential research and development programs, Vertex expects to
incur total restructuring charges of approximately $35 million to $45
million in 2013, including a restructuring charge of approximately $11
million in the third quarter of 2013. Vertex anticipates a reduction in
2014 non-GAAP operating expenses of approximately $150 million to $200
million compared to anticipated 2013 non-GAAP operating expenses of
approximately $1.1 billion. The company is eliminating 370 positions,
primarily related to the support of INCIVEK, representing an
approximately 15 percent reduction in the company’s global workforce.
Approximately 175 positions are being eliminated in Massachusetts.
Third Quarter 2013 Financial Results
Total Revenues: Total revenues for the third quarter of 2013 were
$221.7 million, compared with $336.0 million in total revenues for the
third quarter of 2012. The components of total revenues for the third
quarter and first nine months of 2013 and 2012 were:
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
Product revenues, net
|
|
(in millions)
|
|
(in millions)
|
INCIVEK revenues, net
|
|
$
|
85.6
|
|
|
$
|
254.3
|
|
|
$
|
447.0
|
|
|
$
|
939.0
|
KALYDECO revenues, net
|
|
101.1
|
|
|
49.2
|
|
|
261.8
|
|
|
113.1
|
Total product revenues, net
|
|
186.7
|
|
|
303.5
|
|
|
708.8
|
|
|
1,052.1
|
Royalty revenues
|
|
|
|
|
|
|
|
|
Royalty revenues from INCIVO
|
|
21.0
|
|
|
20.0
|
|
|
104.3
|
|
|
80.8
|
Other royalty revenues
|
|
6.0
|
|
|
5.6
|
|
|
15.4
|
|
|
17.2
|
Total royalty revenues
|
|
27.0
|
|
|
25.6
|
|
|
119.7
|
|
|
98.0
|
Collaborative revenues
|
|
8.0
|
|
|
6.9
|
|
|
32.3
|
|
|
42.9
|
Total revenues
|
|
$
|
221.7
|
|
|
$
|
336.0
|
|
|
$
|
860.8
|
|
|
$
|
1,193.0
|
A table of the components of total revenues on a quarterly basis since
the third quarter of 2012 is provided following the Condensed
Consolidated Statements of Operations Data.
-
Net Product Revenues from INCIVEK
Vertex's third quarter 2013 net product revenues from INCIVEK were $85.6
million, compared to $254.3 million for the third quarter of 2012. The
reduced revenues from INCIVEK were due to fewer HCV patients initiating
treatment in the third quarter of 2013 compared to the third quarter of
2012 as well as a reduction in channel inventory and a reduced realized
price due to changes in the payer mix. Vertex expects a continued
decline in INCIVEK revenues as people with hepatitis C await new
treatment options.
-
Net Product Revenues from KALYDECO
Vertex's third quarter 2013 net product revenues from KALYDECO were
$101.1 million, compared to $49.2 million for the third quarter of 2012.
The increased revenues, compared to the third quarter of 2012, resulted
primarily from the rapid uptake of KALYDECO in eligible patients in
Europe following the conclusion of reimbursement discussions. Nearly all
eligible patients with the G551D mutation in the United States and
Europe have started treatment with KALYDECO. In 2014, further growth in
KALYDECO revenues is dependent on completion of reimbursement
discussions in Australia and Canada for eligible patients with the G551D
mutation and on the potential approval of ivacaftor for use in people
with non-G551D gating mutations, as well as in people with CF who have
the R117H mutation.
-
Royalty Revenues from INCIVO®
Vertex recognized $21.0 million in INCIVO royalty revenues for the third
quarter of 2013 from our collaborator Janssen, compared to $20.0 million
in INCIVO royalty revenues for the third quarter of 2012.
Cost of Product Revenues: Cost of product revenues was $20.0
million for the third quarter of 2013, compared to cost of product
revenues of $30.7 million for the third quarter of 2012.
Research and Development (R&D) Expenses: R&D expenses were
$228.6 million for the third quarter of 2013, including $26.9 million of
Vertex stock-based compensation expense and Alios expenses related to
the accounting for the collaboration with Vertex, compared to $200.2
million for the third quarter of 2012, including $21.3 million of Vertex
stock-based compensation expense and Alios expenses related to the
accounting for the collaboration with Vertex. The increase in Vertex's
R&D investment is principally due to progression and expansion of
clinical development programs in cystic fibrosis and development of
all-oral hepatitis C treatment regimens, including initiation of a
pivotal program for a combination of lumacaftor and ivacaftor.
Sales, General and Administrative (SG&A) Expenses: SG&A
expenses were $87.8 million for the third quarter of 2013, including
$13.4 million of Vertex stock-based compensation expense and Alios
expenses related to the accounting for the collaboration with Vertex,
compared to $97.7 million for the third quarter of 2012, including $10.9
million of Vertex stock-based compensation expense and Alios expenses
related to the accounting for the collaboration with Vertex. This
decrease in SG&A expenses resulted primarily from reduced HCV marketing
and commercial expenses, partially offset by increased investment to
support the expanded global use of KALYDECO.
GAAP Net Loss Attributable to Vertex: Vertex's third quarter 2013
GAAP net loss was $(124.1) million, or $(0.54) per share, including
certain charges of $49.7 million, comprised primarily of stock-based
compensation expense and a restructuring charge. Vertex's GAAP net loss
for the third quarter of 2012 was $(57.5) million, or $(0.27) per
diluted share, including $85.7 million in certain charges.
Non-GAAP Net Income (Loss) Attributable to Vertex: Vertex's third
quarter 2013 non-GAAP net loss was $(74.4) million, or $(0.32) per
diluted share. Vertex's non-GAAP net income for the third quarter of
2012 was $28.2 million, or $0.13 per diluted share. The decrease in the
company's third quarter 2013 non-GAAP net income (loss), compared to the
third quarter of 2012, is primarily attributable to a decrease in total
revenues, specifically decreased INCIVEK revenues due to fewer HCV
patients initiating treatment. Total non-GAAP operating expenses for the
third quarter of 2013 were consistent with the third quarter of 2012.
Cash Position: As of September 30, 2013, Vertex had $1.42 billion
in cash, cash equivalents and marketable securities compared to $1.32
billion in cash, cash equivalents and marketable securities as of
December 31, 2012.
2013 Financial Guidance
This section contains forward-looking guidance about the financial
outlook for Vertex Pharmaceuticals.
Vertex today updated its financial guidance for 2013 total net revenues
and 2013 KALYDECO net revenues. The company now expects lower 2013 total
net revenues in the range of $1.0 billion to $1.05 billion. The company
also now expects higher total 2013 KALYDECO net revenues in the range of
$360 million to $365 million.
The company also today updated its financial guidance for total 2013
non-GAAP operating expenses, excluding cost of revenues, stock-based
compensation expense, restructuring charges, intangible asset impairment
charges, certain interest expenses related to the 2015 Notes, transition
costs related to the relocation of our corporate headquarters and Alios
expenses related to the accounting for the collaboration with Vertex.
Vertex now expects total 2013 non-GAAP operating expenses of
approximately $1.1 billion, which is within the range provided
previously for total 2013 non-GAAP operating expenses.
Vertex expects to end 2013 with a cash position of approximately $1.3
billion. Based on the reduction in global workforce and the resulting
investment focus announced today in a separate press release, the
company anticipates a reduction in 2014 non-GAAP operating expenses of
approximately $150 million to $200 million compared to anticipated 2013
non-GAAP operating expenses of approximately $1.1 billion.
Non-GAAP Financial Measures
In this press release, Vertex's financial results and financial guidance
are provided in accordance with accounting principles generally accepted
in the United States (GAAP) and using certain non-GAAP financial
measures. In particular, Vertex provides its non-GAAP net income (loss)
for the periods ending September 30, 2013 and 2012 excluding stock-based
compensation expense, restructuring expense, inventory reserves,
intangible asset impairment charges, net of tax, certain interest
expenses related to the 2015 Notes and charges related to changes in the
fair value of expected future payments under Vertex's collaboration with
Alios. 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. A reconciliation of the GAAP financial results to non-GAAP
financial results is included in the attached financial statements.
Vertex Pharmaceuticals Incorporated
|
Third Quarter and Nine Month Results
|
Condensed Consolidated Statements of Operations Data
|
(in thousands, except per share amounts)
|
(unaudited)
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
Revenues:
|
|
|
|
|
|
|
|
|
Product revenues, net
|
|
$
|
186,653
|
|
|
$
|
303,501
|
|
|
$
|
708,823
|
|
|
$
|
1,052,149
|
|
Royalty revenues
|
|
27,012
|
|
|
25,586
|
|
|
119,705
|
|
|
98,047
|
|
Collaborative revenues
|
|
8,035
|
|
|
6,919
|
|
|
32,290
|
|
|
42,852
|
|
Total revenues
|
|
221,700
|
|
|
336,006
|
|
|
860,818
|
|
|
1,193,048
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
Cost of product revenues (Note 1)
|
|
20,048
|
|
|
30,680
|
|
|
75,698
|
|
|
161,147
|
|
Royalty expenses
|
|
7,291
|
|
|
7,856
|
|
|
32,315
|
|
|
31,023
|
|
Research and development expenses (R&D)
|
|
228,567
|
|
|
200,161
|
|
|
669,117
|
|
|
593,076
|
|
Sales, general and administrative expenses (SG&A)
|
|
87,804
|
|
|
97,684
|
|
|
287,204
|
|
|
326,344
|
|
Restructuring expense (Note 2)
|
|
12,048
|
|
|
696
|
|
|
12,863
|
|
|
1,650
|
|
Intangible asset impairment charge (Note 3)
|
|
—
|
|
|
—
|
|
|
412,900
|
|
|
—
|
|
Total costs and expenses
|
|
355,758
|
|
|
337,077
|
|
|
1,490,097
|
|
|
1,113,240
|
|
Income (loss) from operations
|
|
(134,058
|
)
|
|
(1,071
|
)
|
|
(629,279
|
)
|
|
79,808
|
|
Other income (expense), net (Note 4)
|
|
4,652
|
|
|
(4,041
|
)
|
|
(6,578
|
)
|
|
(11,417
|
)
|
Income (loss) before provision for (benefit from) income taxes
|
|
(129,406
|
)
|
|
(5,112
|
)
|
|
(635,857
|
)
|
|
68,391
|
|
Provision for (benefit from) income taxes (Note 3)
|
|
(751
|
)
|
|
21,355
|
|
|
(132,863
|
)
|
|
41,450
|
|
Net income (loss)
|
|
(128,655
|
)
|
|
(26,467
|
)
|
|
(502,994
|
)
|
|
26,941
|
|
Net loss (income) attributable to noncontrolling interest (Note 5)
|
|
4,530
|
|
|
(31,076
|
)
|
|
13,688
|
|
|
(57,825
|
)
|
Net income (loss) attributable to Vertex
|
|
$
|
(124,125
|
)
|
|
$
|
(57,543
|
)
|
|
$
|
(489,306
|
)
|
|
$
|
(30,884
|
)
|
|
|
|
|
|
|
|
|
|
Net loss per share attributable to Vertex common shareholders:
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
(0.54
|
)
|
|
$
|
(0.27
|
)
|
|
$
|
(2.20
|
)
|
|
$
|
(0.15
|
)
|
Diluted
|
|
$
|
(0.54
|
)
|
|
$
|
(0.27
|
)
|
|
$
|
(2.20
|
)
|
|
$
|
(0.15
|
)
|
|
|
|
|
|
|
|
|
|
Shares used in per share calculations:
|
|
|
|
|
|
|
|
|
Basic
|
|
230,505
|
|
|
213,767
|
|
|
222,764
|
|
|
211,053
|
|
Diluted
|
|
230,505
|
|
|
213,767
|
|
|
222,764
|
|
|
211,053
|
|
Consolidated Revenues
|
(in millions)
|
(unaudited)
|
|
|
|
Three Months Ended
|
|
September 30, 2013
|
|
June 30, 2013
|
|
March 31, 2013
|
|
December 31, 2012
|
|
September 30, 2012
|
Product revenues, net
|
|
INCIVEK revenues, net
|
$
|
85.6
|
|
|
$
|
155.8
|
|
|
$
|
205.6
|
|
|
$
|
222.8
|
|
|
$
|
254.3
|
KALYDECO revenues, net
|
101.1
|
|
|
99.0
|
|
|
61.8
|
|
|
58.5
|
|
|
49.2
|
Total product revenues, net
|
186.7
|
|
|
254.8
|
|
|
267.4
|
|
|
281.3
|
|
|
303.5
|
Royalty revenues
|
|
|
|
|
|
|
|
|
|
Royalty revenues from INCIVO
|
21.0
|
|
|
44.1
|
|
|
39.0
|
|
|
36.8
|
|
|
20.0
|
Other royalty revenues
|
6.0
|
|
|
5.0
|
|
|
4.5
|
|
|
6.7
|
|
|
5.6
|
Total royalty revenues
|
27.0
|
|
|
49.1
|
|
|
43.6
|
|
|
43.5
|
|
|
25.6
|
Collaborative revenues
|
8.0
|
|
|
6.8
|
|
|
17.4
|
|
|
9.2
|
|
|
6.9
|
Total revenues
|
$
|
221.7
|
|
|
$
|
310.8
|
|
|
$
|
328.4
|
|
|
$
|
334.0
|
|
|
$
|
336.0
|
Reconciliation of GAAP to Non-GAAP Financial Information-Third
Quarter
|
(in thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, 2013
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments
|
|
|
|
|
GAAP
|
|
Alios Transaction
|
|
Stock-based Compensation Expense
|
|
Inventory Write-off and Restructuring Expenses
|
|
Non-GAAP
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations
|
|
$
|
(134,058
|
)
|
|
$
|
9,052
|
|
|
$
|
31,197
|
|
|
$
|
17,324
|
|
|
$
|
(76,485
|
)
|
Other income (expense), net
|
|
4,652
|
|
|
4
|
|
|
—
|
|
|
—
|
|
|
4,656
|
|
Income (loss) before provision for (benefit from) income taxes
|
|
(129,406
|
)
|
|
9,056
|
|
|
31,197
|
|
|
17,324
|
|
|
(71,829
|
)
|
Provision for (benefit from) income taxes
|
|
(751
|
)
|
|
3,306
|
|
|
—
|
|
|
—
|
|
|
2,555
|
|
Net income (loss)
|
|
(128,655
|
)
|
|
5,750
|
|
|
31,197
|
|
|
17,324
|
|
|
(74,384
|
)
|
Net loss (income) attributable to noncontrolling interest (Alios)
|
|
4,530
|
|
|
(4,530
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
Net income (loss) attributable to Vertex
|
|
$
|
(124,125
|
)
|
|
$
|
1,220
|
|
|
$
|
31,197
|
|
|
$
|
17,324
|
|
|
$
|
(74,384
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per diluted share attributable to Vertex common
shareholders (Note 6)
|
|
$
|
(0.54
|
)
|
|
|
|
|
|
|
|
$
|
(0.32
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, 2012
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments
|
|
|
|
|
GAAP
|
|
Alios Transaction
|
|
Stock-based Compensation Expense
|
|
Restructuring Expenses
|
|
Non-GAAP
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations
|
|
(1,071
|
)
|
|
4,624
|
|
|
27,484
|
|
|
696
|
|
|
31,733
|
|
Other income (expense), net
|
|
(4,041
|
)
|
|
466
|
|
|
—
|
|
|
—
|
|
|
(3,575
|
)
|
Income (loss) before provision for (benefit from) income taxes
|
|
(5,112
|
)
|
|
5,090
|
|
|
27,484
|
|
|
696
|
|
|
28,158
|
|
Provision for (benefit from) income taxes
|
|
21,355
|
|
|
(21,394
|
)
|
|
—
|
|
|
—
|
|
|
(39
|
)
|
Net income (loss)
|
|
(26,467
|
)
|
|
26,484
|
|
|
27,484
|
|
|
696
|
|
|
28,197
|
|
Net loss (income) attributable to noncontrolling interest (Alios)
|
|
(31,076
|
)
|
|
31,076
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Net income (loss) attributable to Vertex
|
|
(57,543
|
)
|
|
57,560
|
|
|
27,484
|
|
|
696
|
|
|
28,197
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per diluted share attributable to Vertex common
shareholders (Note 6)
|
|
$
|
(0.27
|
)
|
|
|
|
|
|
|
|
$
|
0.13
|
|
Reconciliation of GAAP to Non-GAAP Financial Information-Third
Quarter
|
(in thousands)
|
(unaudited)
|
|
|
|
Three Months Ended September 30,
|
|
|
2013
|
|
2012
|
GAAP total costs and expenses
|
|
$
|
355,758
|
|
|
$
|
337,077
|
|
Adjustments:
|
|
|
|
|
Cost of product revenues (Note 1) and royalty expenses
|
|
(27,339
|
)
|
|
(38,536
|
)
|
Stock-based compensation expense
|
|
(31,197
|
)
|
|
(27,484
|
)
|
Alios transaction (Note 5)
|
|
(9,052
|
)
|
|
(4,624
|
)
|
Restructuring expenses (Note 2)
|
|
(12,048
|
)
|
|
(696
|
)
|
Non-GAAP total costs and expenses
|
|
$
|
276,122
|
|
|
$
|
265,737
|
|
|
|
|
|
|
GAAP research and development expenses
|
|
$
|
228,567
|
|
|
$
|
200,161
|
|
Adjustments:
|
|
|
|
|
Stock-based compensation expense
|
|
(19,137
|
)
|
|
(17,396
|
)
|
Alios transaction (Note 5)
|
|
(7,725
|
)
|
|
(3,862
|
)
|
Non-GAAP research and development expenses
|
|
$
|
201,705
|
|
|
$
|
178,903
|
|
|
|
|
|
|
GAAP sales, general, and administrative expenses
|
|
$
|
87,804
|
|
|
$
|
97,684
|
|
Adjustments:
|
|
|
|
|
Stock-based compensation expense
|
|
(12,060
|
)
|
|
(10,088
|
)
|
Alios transaction (Note 5)
|
|
(1,327
|
)
|
|
(762
|
)
|
Non-GAAP sales, general, and administrative expenses
|
|
$
|
74,417
|
|
|
$
|
86,834
|
|
Reconciliation of GAAP to Non-GAAP Financial Information-Nine
Month
|
(in thousands, except per share amounts)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, 2013
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments
|
|
|
|
|
|
|
|
GAAP
|
|
Alios Transaction
|
|
Stock-based Compensation Expense
|
|
Inventory Write -off, Intangible Asset and Restructuring Charges
|
|
Debt Conversion Costs
|
|
Non-GAAP
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations
|
|
$
|
(629,279
|
)
|
|
$
|
21,348
|
|
|
$
|
103,613
|
|
|
$
|
436,121
|
|
|
$
|
—
|
|
|
$
|
(68,197
|
)
|
Other income (expense), net
|
|
(6,578
|
)
|
|
(171
|
)
|
|
—
|
|
|
—
|
|
|
3,908
|
|
|
(2,841
|
)
|
Income (loss) before provision for (benefit from) income taxes
|
|
(635,857
|
)
|
|
21,177
|
|
|
103,613
|
|
|
436,121
|
|
|
3,908
|
|
|
(71,038
|
)
|
Provision for (benefit from) income taxes
|
|
(132,863
|
)
|
|
9,089
|
|
|
—
|
|
|
127,586
|
|
|
—
|
|
|
3,812
|
|
Net income (loss)
|
|
(502,994
|
)
|
|
12,088
|
|
|
103,613
|
|
|
308,535
|
|
|
3,908
|
|
|
(74,850
|
)
|
Net loss (income) attributable to noncontrolling interest (Alios)
|
|
13,688
|
|
|
(13,688
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Net income (loss) attributable to Vertex
|
|
$
|
(489,306
|
)
|
|
$
|
(1,600
|
)
|
|
$
|
103,613
|
|
|
$
|
308,535
|
|
|
$
|
3,908
|
|
|
$
|
(74,850
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per diluted share attributable to Vertex common
shareholders (Note 6)
|
|
$
|
(2.20
|
)
|
|
|
|
|
|
|
|
|
|
$
|
(0.34
|
)
|
Nine Months Ended September 30, 2012
|
|
|
|
|
|
|
|
|
|
|
Adjustments
|
|
|
|
|
|
|
|
GAAP
|
|
Alios Transaction
|
|
Stock-based Compensation Expense
|
|
Inventory Write-off and Restructuring Charges
|
|
Non-GAAP
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations
|
|
$
|
79,808
|
|
|
$
|
14,356
|
|
|
$
|
86,280
|
|
|
$
|
79,650
|
|
|
$
|
260,094
|
|
Other income (expense), net
|
|
(11,417
|
)
|
|
225
|
|
|
—
|
|
|
—
|
|
|
(11,192
|
)
|
Income (loss) before provision for (benefit from) income taxes
|
|
68,391
|
|
|
14,581
|
|
|
86,280
|
|
|
79,650
|
|
|
248,902
|
|
Provision for (benefit from) income taxes
|
|
41,450
|
|
|
(40,354
|
)
|
|
—
|
|
|
1,239
|
|
|
2,335
|
|
Net income (loss)
|
|
26,941
|
|
|
54,935
|
|
|
86,280
|
|
|
78,411
|
|
|
246,567
|
|
Net loss (income) attributable to noncontrolling interest (Alios)
|
|
(57,825
|
)
|
|
57,825
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Net income (loss) attributable to Vertex
|
|
$
|
(30,884
|
)
|
|
$
|
112,760
|
|
|
$
|
86,280
|
|
|
$
|
78,411
|
|
|
$
|
246,567
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per diluted share attributable to Vertex common
shareholders (Note 6)
|
|
$
|
(0.15
|
)
|
|
|
|
|
|
|
|
$
|
1.15
|
|
Reconciliation of GAAP to Non-GAAP Financial Information-Nine
Month
|
(in thousands)
|
(unaudited)
|
|
|
|
Nine Months Ended September 30,
|
|
2013
|
|
2012
|
GAAP total costs and expenses
|
$
|
1,490,097
|
|
|
$
|
1,113,240
|
|
Adjustments:
|
|
|
|
Cost of product revenues (Note 1) and royalty expenses
|
(108,013
|
)
|
|
(192,170
|
)
|
Stock-based compensation expense
|
(103,613
|
)
|
|
(86,280
|
)
|
Alios transaction (Note 5)
|
(21,348
|
)
|
|
(14,356
|
)
|
Intangible asset impairment charge (Note 3) and restructuring
expenses (Note 2)
|
(425,763
|
)
|
|
(1,650
|
)
|
Non-GAAP total costs and expenses
|
$
|
831,360
|
|
|
$
|
818,784
|
|
|
|
|
|
GAAP research and development expenses
|
$
|
669,117
|
|
|
$
|
593,076
|
|
Adjustments:
|
|
|
|
Stock-based compensation expense
|
(64,110
|
)
|
|
(54,223
|
)
|
Alios transaction (Note 5)
|
(17,339
|
)
|
|
(11,480
|
)
|
Non-GAAP research and development expenses
|
$
|
587,668
|
|
|
$
|
527,373
|
|
|
|
|
|
GAAP sales, general, and administrative expenses
|
$
|
287,204
|
|
|
$
|
326,344
|
|
Adjustments:
|
|
|
|
Stock-based compensation expense
|
(39,503
|
)
|
|
(32,057
|
)
|
Alios transaction (Note 5)
|
(4,009
|
)
|
|
(2,876
|
)
|
Non-GAAP sales, general, and administrative expenses
|
$
|
243,692
|
|
|
$
|
291,411
|
|
Condensed Consolidated Balance Sheets Data
|
(in thousands)
|
(unaudited)
|
|
|
|
|
|
September 30, 2013
|
|
December 31, 2012
|
Assets
|
|
|
|
Cash, cash equivalents and marketable securities
|
$
|
1,422,650
|
|
|
$
|
1,321,215
|
Restricted cash and cash equivalents (Alios) (Note 5)
|
51,059
|
|
|
69,983
|
Accounts receivable, net
|
120,281
|
|
|
143,250
|
Inventories (Note 1)
|
13,543
|
|
|
30,464
|
Other current assets
|
41,105
|
|
|
24,673
|
Restricted cash
|
127
|
|
|
31,934
|
Property and equipment, net
|
648,924
|
|
|
433,609
|
Intangible assets (Note 3)
|
250,600
|
|
|
663,500
|
Goodwill
|
30,992
|
|
|
30,992
|
Other non-current assets
|
3,474
|
|
|
9,668
|
Total assets
|
$
|
2,582,755
|
|
|
$
|
2,759,288
|
|
|
|
|
Liabilities and Shareholders' Equity
|
|
|
|
Other liabilities
|
$
|
418,798
|
|
|
$
|
429,372
|
Accrued restructuring expense (Note 2)
|
26,138
|
|
|
23,328
|
Deferred tax liability (Note 3)
|
150,203
|
|
|
280,367
|
Deferred revenues
|
108,361
|
|
|
123,808
|
Construction financing lease obligation
|
392,569
|
|
|
268,031
|
Convertible notes (due 2015) (Note 4)
|
—
|
|
|
400,000
|
Noncontrolling interest (Alios) (Note 5)
|
221,792
|
|
|
235,202
|
Shareholders' equity (Vertex)
|
1,264,894
|
|
|
999,180
|
Total liabilities and shareholders' equity
|
$
|
2,582,755
|
|
|
$
|
2,759,288
|
|
|
|
|
Common shares outstanding
|
233,592
|
|
|
217,287
|
Note 1: In the three and nine months ended September 30, 2013,
the company recorded within cost of product revenues reserves for excess
and obsolete inventories of $5.3 million and $10.4 million,
respectively. In the nine months ended September 30, 2012, the company
recorded within cost of product revenues reserves for excess and
obsolete inventories of $78.0 million.
Note 2: On October 29, 2013, the company announced a
restructuring in which it recorded $11.4 million in restructuring
expenses during the three months ended September 30, 2013. The company
expects to record the majority of the remaining expenses associated with
this restructuring in the fourth quarter of 2013.
Note 3: As of September 30, 2013, the intangible assets and
deferred tax liability reflected in the condensed consolidated balance
sheet relate to the company's collaboration agreement with Alios
BioPharma, Inc. (Alios).
In the first quarter of 2013, the company determined that the value of
VX-222 had become impaired and that the fair value of VX-222 was zero as
of March 31, 2013. This resulted in a $412.9 million impairment charge.
In connection with this impairment charge, the company recorded a credit
of $127.6 million in its provision for income taxes.
Note 4: In the second quarter of 2013, the company elected to
redeem $400.0 million in aggregate principal amount of 3.35% convertible
senior subordinated notes due 2015 (“2015 Notes”). In response, the
holders of the 2015 Notes converted their 2015 Notes into approximately
8.2 million shares of the company's common stock. In accordance with the
terms of the 2015 Notes, the company made additional make-whole interest
payments of $6.7 million, payable in shares of the company's common
stock.
Note 5: The company has consolidated the financial statements of
its collaborator Alios as of September 30, 2013, December 31, 2012, and
for the three and nine months ended September 30, 2013 and 2012. The
company's interest and obligations with respect to Alios' assets and
liabilities are limited to those accorded to the company in its
collaboration agreement with Alios. Restricted cash and cash equivalents
(Alios) reflects Alios' cash and cash equivalents, which Vertex does not
have any interest in and which will not be used to fund the
collaboration. Each reporting period Vertex estimates the fair value of
the contingent milestone payments and royalties payable by Vertex to
Alios. Any increase in the fair value of these contingent milestone and
royalty payments results in a decrease in net income attributable to
Vertex (or an increase in net loss attributable to Vertex) on a
dollar-for-dollar basis.
Note 6: Shares used in non-GAAP net income (loss) per diluted
share attributable to Vertex common shareholders were 230,505,000 and
217,797,000 for the three months ended September 30, 2013 and 2012,
respectively, and 222,764,000 and 214,580,000 for the nine months ended
September 30, 2013 and 2012, respectively.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR KALYDECO™ (ivacaftor)
Ivacaftor (150mg tablets) is indicated for the treatment of cystic
fibrosis (CF) in patients age 6 years and older who have a G551D mutation
in the CFTR gene.
Ivacaftor is not for use in people with CF due to other mutations in the CFTR gene.
It is not effective in patients with CF with 2 copies of the F508del mutation
(F508del/F508del) in the CFTR gene. The efficacy and
safety of ivacaftor in children younger than 6 years of age have not
been evaluated.
Elevated liver enzymes (transaminases; ALT and AST) have been reported
in patients receiving ivacaftor. It is recommended that ALT and AST be
assessed prior to initiating ivacaftor, every 3 months during the first
year of treatment, and annually thereafter. Patients who develop
increased transaminase levels should be closely monitored until the
abnormalities resolve. Dosing should be interrupted in patients with ALT
or AST of greater than 5 times the upper limit of normal. Following
resolution of transaminase elevations, consider the benefits and risks
of resuming ivacaftor dosing.
Use of ivacaftor with medicines that are strong CYP3A inducers, such as
the antibiotics rifampin and rifabutin; seizure medications
(phenobarbital, carbamazepine, or phenytoin); and the herbal supplement
St. John's Wort, substantially decreases exposure of ivacaftor which may
diminish effectiveness. Therefore, co-administration is not recommended.
The dose of ivacaftor must be adjusted when used concomitantly with
potent and moderate CYP3A inhibitors. The dose of ivacaftor must be
adjusted when used in patients with moderate or severe hepatic disease.
Ivacaftor can cause serious adverse reactions including abdominal pain
and high liver enzymes in the blood. The most common side effects
associated with ivacaftor include headache; upper respiratory tract
infection (the common cold), including sore throat, nasal or sinus
congestion, and runny nose; stomach (abdominal) pain; diarrhea; rash;
and dizziness. These are not all the possible side effects of ivacaftor.
A list of the adverse reactions can be found in the product labeling for
each country where ivacaftor is approved. Patients should tell their
healthcare providers about any side effect that bothers them or does not
go away.
Please see full U.S. Prescribing Information for KALYDECO at www.KALYDECO.com,
the EU Summary of Product Characteristics for KALYDECO at http://goo.gl/N3Tz4,
the Canadian Product Monograph for KALYDECO at www.vrtx.ca
and the Australian Consumer Medical Information and Product Information
for KALYDECO at http://bit.ly/18wlMld.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR INCIVEK (telaprevir)
INCIVEK® (telaprevir) is a prescription medicine used
with the medicines peginterferon alfa and ribavirin to treat chronic
(lasting a long time) hepatitis C genotype 1 infection in adults with
stable liver problems, who have not been treated before or who have
failed previous treatment. It is not known if INCIVEK is safe and
effective in children under 18 years of age.
Important Safety Information
INCIVEK® (telaprevir) should always be used in combination with
peginterferon alfa and ribavirin. INCIVEK combination treatment may
cause serious side effects including skin rash and serious skin
reactions, anemia (low red blood cell count) that can be severe, and
birth defects or death of an unborn baby.
Skin rashes are common with INCIVEK combination treatment. Sometimes
these skin rashes and other skin reactions can become serious, require
treatment in a hospital, and may lead to death. Patients should
call their healthcare provider right away if they develop any skin
changes or itching during treatment with INCIVEK. Their healthcare
provider will decide if they need treatment or if they need to stop
INCIVEK or any of their other medicines. Patients should not stop taking
INCIVEK combination treatment without talking with their healthcare
provider first.
Patients' healthcare providers will do blood tests regularly to check
for anemia. If anemia is severe, the healthcare providers may tell them
to stop taking INCIVEK.
INCIVEK combined with peginterferon alfa and ribavirin may cause birth
defects or death of an unborn baby. Therefore, a patient should not take
INCIVEK combination treatment if she is pregnant or may become pregnant,
or if he is a man with a sexual partner who is pregnant. Females who can
become pregnant and females whose male partner takes these medicines
must have a negative pregnancy test before starting treatment, every
month during treatment, and for 6 months after treatment ends. Patients
must use two forms of effective birth control during treatment and for 6
months after all treatment has ended. These two forms of birth control
should not contain hormones, as these may not work during treatment with
INCIVEK.
INCIVEK and other medicines can affect each other and can also cause
side effects that can be serious or life-threatening. There are certain
medicines patients cannot take with INCIVEK combination treatment.
Patients should tell their healthcare providers about all the medicines
they take, including prescription and over-the-counter medicines,
vitamins and herbal supplements.
The most common side effects of INCIVEK combination treatment include
itching, nausea, diarrhea, vomiting, anal or rectal problems (including
hemorrhoids, discomfort, burning or itching around or near the anus),
taste changes and tiredness. There are other possible side effects of
INCIVEK, and side effects associated with peginterferon alfa and
ribavirin also apply to INCIVEK combination treatment. Patients should
tell their healthcare provider about any side effect that bothers them
or doesn't go away.
Please see full Prescribing Information including Boxed Warning, and the
Medication Guide for INCIVEK available at www.INCIVEK.com.
About Vertex
Vertex is a global biotechnology company that aims to discover, develop
and commercialize innovative medicines so people with serious diseases
can lead better lives. Vertex scientists and our collaborators are
working on new medicines to cure or significantly advance the treatment
of cystic fibrosis, hepatitis C, rheumatoid arthritis and other
life-threatening diseases. In addition to our clinical development
programs, Vertex has more than a dozen ongoing preclinical programs
aimed at other serious and life-threatening diseases.
Founded in 1989 in Cambridge, Mass., Vertex today has research and
development sites and commercial offices in the United States, Europe,
Canada and Australia. For four years in a row, Science magazine has
named Vertex one of its Top Employers in the life sciences. For
additional information and the latest updates from the company, please
visit www.vrtx.com.
Special Note Regarding Forward-looking Statements
This press release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, including, without
limitation, Dr. Leiden's statements in the third paragraph of the press
release, the information provided in the sections captioned “Workforce
Reduction and Investment Focus on Future Opportunities in Cystic
Fibrosis and Other Key Research and Development Programs” and "2013
Financial Guidance" and statements regarding (i) expected non-GAAP
operating expense in 2013 and 2014; (ii) the company focusing its
investment on future opportunities in cystic fibrosis and other research
and development programs, including VX-135; (iii) the timing of receipt
of data from studies, including the Phase 3 studies of lumacaftor and
ivacaftor and studies of VX-135 in combination with daclatasvir; (iv)
the research efforts aimed at beginning clinical development of a next
generation corrector; (v) the timing of potential regulatory submissions
to the FDA and in Europe; (vi) the company's intent to provide further
data to the FDA regarding VX-135; (vii) Vertex pursuing collaborative
opportunities to support further global development of VX-509; (viii)
expectations regarding the restructuring charges and (ix) expectations
regarding future KALYDECO and INCIVEK revenues. While Vertex 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 company's expectations regarding its 2013
revenues and financial results, and its 2013 and 2014 non-GAAP operating
expenses may be incorrect (including because one or more of the
company's assumptions underlying its revenue or expense expectations may
not be realized), that the outcomes of Vertex's ongoing and planned
clinical studies may be delayed or may not support registration or
further development of its compounds due to safety, efficacy, or other
reasons, 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.
Vertex disclaims any obligation to update the information contained in
this press release as new information becomes available.
Conference Call and Webcast
The company will host a conference call and webcast at 8:30 a.m. ET. To
access this call, dial (866) 501-1537 (U.S.) or +1 (720) 545-0001
(International). The conference call will be webcast live, and a link to
the webcast may be accessed from the “Vertex Events” page of Vertex’s
website at www.vrtx.com.
A replay of the conference call and webcast will be archived on the
company’s website until November 5, 2013. To ensure a timely connection,
it is recommended that users register at least 15 minutes prior to the
scheduled webcast.
(VRTX-GEN)
Copyright Business Wire 2013