-Second quarter 2016 cystic fibrosis product revenues of
-Vertex reiterates 2016 guidance for ORKAMBI product revenues of
-Pipeline of investigational CF medicines continues to progress and
expand with addition of recent
Three Months Ended |
|||||||||||
2016 | 2015 | % Change | |||||||||
(in millions, except per share and percentage data) | |||||||||||
ORKAMBI product revenues, net | $ | 245 | $ | — | N/A | ||||||
KALYDECO product revenues, net | $ |
180 |
$ |
155 |
16 | % | |||||
TOTAL CF product revenues, net | $ |
426 |
$ |
155 |
175 | % | |||||
GAAP net loss | $ | (65 | ) | $ | (189 | ) | (66 | )% | |||
GAAP net loss per share | $ | (0.26 | ) | $ | (0.78 | ) | (67 | )% | |||
Non-GAAP net income (loss) | $ | 58 | $ | (131 | ) | N/A | |||||
Non-GAAP net income (loss) per share | $ | 0.24 | $ | (0.54 | ) | N/A | |||||
"Just over a year ago, we received
Vertex today reviewed recent progress from across its CF program:
ORKAMBI
Supplemental New Drug Application for the treatment of children
ages 6 to 11 accepted for Priority Review by the
Enrollment complete in Phase 3 study in children ages 6 to 11 to
support approval in
Initiation of Phase 3 study of ORKAMBI in children ages 2 to 5: Vertex recently initiated a Phase 3 study of ORKAMBI in children ages 2 to 5. Similar to the study of KALYDECO in children in this age group, the first part of the two-part study is evaluating pharmacokinetics and safety to inform dose selection for the second part of the study. The primary endpoint of the second part of the study is safety and tolerability, with multiple efficacy measurements as secondary endpoints.
KALYDECO
Regulatory filing for patients with residual function mutations: In
VX-661 in Combination with Ivacaftor
Data from Phase 3 study in people with two copies of F508del
mutation expected in first half of 2017: Vertex today announced
that it expects to complete enrollment of a 24-week Phase 3
placebo-controlled study evaluating the investigational combination of
VX-661 and ivacaftor in people ages 12 and older who have two copies of
the F508del mutation in
Next-Generation Correctors
Ongoing Phase 1 studies in healthy volunteers: Vertex's two next-generation correctors known as VX-152 and VX-440 are being evaluated alone and as part of a triple combination with VX-661 and ivacaftor in ongoing Phase 1 studies in healthy volunteers. Pending data from the Phase 1 studies, the company expects to begin Phase 2 clinical development in people with CF to evaluate one or both of the next-generation correctors with VX-661 and ivacaftor in the second half of 2016.
New Collaboration to Advance Future Treatment of CF
Collaboration with
Second Quarter 2016 Financial Highlights
Revenues:
Expenses:
Net Income (Loss) Attributable to Vertex:
Cash Position:
2016 Financial Guidance:
Vertex today reiterated its 2016 revenue guidance for ORKAMBI and
KALYDECO. The company also reiterated guidance for its 2016 combined
non-GAAP R&
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
|
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Second Quarter Results |
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Consolidated Statements of Operations Data |
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(in thousands, except per share amounts) |
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(unaudited) |
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Three Months Ended |
Six Months Ended |
||||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||||
Revenues: | |||||||||||||||||
Product revenues, net | $ | 425,651 | $ | 160,388 | $ | 820,061 | $ | 291,263 | |||||||||
Royalty revenues | 5,282 | 5,077 | 8,878 | 11,869 | |||||||||||||
Collaborative revenues | 675 | 611 | 749 | 1,453 | |||||||||||||
Total revenues | 431,608 | 166,076 | 829,688 | 304,585 | |||||||||||||
Costs and expenses: | |||||||||||||||||
Cost of product revenues (Note 1) | 44,154 | 15,409 | 93,943 | 24,790 | |||||||||||||
Royalty expenses | 1,098 | 1,451 | 1,958 | 4,377 | |||||||||||||
Research and development expenses | 271,008 | 223,858 | 526,868 | 439,457 | |||||||||||||
Sales, general and administrative expenses | 111,652 | 94,394 | 216,866 | 180,254 | |||||||||||||
Restructuring expenses (income) | 343 | 2,128 | 1,030 | (1,144 | ) | ||||||||||||
Total costs and expenses | 428,255 | 337,240 | 840,665 | 647,734 | |||||||||||||
Income (loss) from operations | 3,353 | (171,164 | ) | (10,977 | ) | (343,149 | ) | ||||||||||
Interest expense, net | (20,155 | ) | (21,111 | ) | (40,853 | ) | (42,418 | ) | |||||||||
Other (expenses) income, net | (1,219 | ) | 1,414 | 3,192 | (3,699 | ) | |||||||||||
Loss from operations before provision for income taxes | (18,021 | ) | (190,861 | ) | (48,638 | ) | (389,266 | ) | |||||||||
Provision for income taxes | 18,130 | 30,131 | 23,615 | 30,430 | |||||||||||||
Net loss | (36,151 | ) | (220,992 | ) | (72,253 | ) | (419,696 | ) | |||||||||
(Income) loss attributable to noncontrolling interest | (28,374 | ) | 32,144 | (33,903 | ) | 32,242 | |||||||||||
Net loss attributable to Vertex | $ | (64,525 | ) | $ | (188,848 | ) | $ | (106,156 | ) | $ | (387,454 | ) | |||||
Amounts per share attributable to Vertex common shareholders: | |||||||||||||||||
Net loss: | |||||||||||||||||
Basic and diluted | $ | (0.26 | ) | $ | (0.78 | ) | $ | (0.43 | ) | $ | (1.61 | ) | |||||
Shares used in per share calculations: | |||||||||||||||||
Basic and diluted |
244,482 |
240,757 |
244,124 |
240,129 | |||||||||||||
Reconciliation of GAAP to Non-GAAP Net Income/(Loss) |
|||||||||||||||||
Second Quarter Results |
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(in thousands, except per share amounts) |
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(unaudited) |
|||||||||||||||||
Three Months Ended |
Six Months Ended |
||||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||||
GAAP loss attributable to Vertex | $ | (64,525 | ) | $ | (188,848 | ) | $ | (106,156 | ) | $ | (387,454 | ) | |||||
Stock-based compensation expense | 61,942 | 63,261 | 117,414 | 120,645 | |||||||||||||
Real estate restructuring costs and income (Note 2) | 137 | 1,178 | 575 | (2,400 | ) | ||||||||||||
HCV related revenues and costs (Note 3) | 627 | (6,004 | ) | (810 | ) | (10,473 | ) | ||||||||||
Other adjustments (Notes 4 and 5) | 59,791 | (270 | ) | 69,371 | 623 | ||||||||||||
Non-GAAP net income (loss) attributable to Vertex | $ | 57,972 | $ | (130,683 | ) | $ | 80,394 | $ | (279,059 | ) | |||||||
Amounts per diluted share attributable to Vertex common shareholders: | |||||||||||||||||
GAAP | $ | (0.26 | ) | $ | (0.78 | ) | $ | (0.43 | ) | $ | (1.61 | ) | |||||
Non-GAAP | $ | 0.24 | $ | (0.54 | ) | $ | 0.33 | $ | (1.16 | ) | |||||||
Shares used in diluted per share calculations: | |||||||||||||||||
GAAP |
244,482 |
240,757 |
244,124 |
240,129 | |||||||||||||
Non-GAAP | 246,426 | 240,757 |
246,872 |
240,129 | |||||||||||||
Reconciliation of GAAP to Non-GAAP Revenues and Expenses |
|||||||||||||||||
Second Quarter Results |
|||||||||||||||||
(in thousands) |
|||||||||||||||||
(unaudited) |
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Three Months Ended |
Six Months Ended |
||||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||||
GAAP total revenues | $ | 431,608 | $ | 166,076 | $ | 829,688 | $ | 304,585 | |||||||||
HCV related revenues (Note 3) | 489 | (6,094 | ) | (362 | ) | (8,963 | ) | ||||||||||
Other adjustments (Note 4) | (573 | ) | (74 | ) | (647 | ) | (274 | ) | |||||||||
Non-GAAP total revenues |
$ | 431,524 | $ | 159,908 | $ | 828,679 | $ | 295,348 | |||||||||
Three Months Ended |
Six Months Ended |
||||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||||
GAAP cost of product revenues and royalty expenses | $ | 45,252 | $ | 16,860 | $ | 95,901 | $ | 29,167 | |||||||||
HCV related costs (Note 3) | 6 | (371 | ) | (133 | ) | (1,968 | ) | ||||||||||
Non-GAAP cost of product revenues and royalty expenses |
$ | 45,258 | $ | 16,489 | $ | 95,768 | $ | 27,199 | |||||||||
GAAP research and development expenses | $ | 271,008 | $ | 223,858 | $ | 526,868 | $ | 439,457 | |||||||||
Stock-based compensation expense | (40,640 | ) | (41,632 | ) | (75,088 | ) | (79,849 | ) | |||||||||
HCV related costs (Note 3) | 51 | 512 | 877 | 1,000 | |||||||||||||
Other adjustments (Note 4) | (12,746 | ) | (827 | ) | (12,937 | ) | (1,520 | ) | |||||||||
Non-GAAP research and development expenses |
$ | 217,673 | $ | 181,911 | $ | 439,720 | $ | 359,088 | |||||||||
GAAP sales, general and administrative expenses | $ | 111,652 | $ | 94,394 | $ | 216,866 | $ | 180,254 | |||||||||
Stock-based compensation expense | (21,302 | ) | (21,629 | ) | (42,326 | ) | (40,796 | ) | |||||||||
HCV related costs (Note 3) | (61 | ) | (54 | ) | (29 | ) | 2,851 | ||||||||||
Other adjustments (Note 4) | (1,698 | ) | (695 | ) | (2,241 | ) | (1,147 | ) | |||||||||
Non-GAAP sales, general and administrative expenses | $ | 88,591 | $ | 72,016 | $ | 172,270 | $ | 141,162 | |||||||||
Combined non-GAAP R& |
$ | 306,264 | $ | 253,927 | $ | 611,990 | $ | 500,250 | |||||||||
Three Months Ended |
Six Months Ended |
||||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||||
GAAP interest expense, net and other expense, net | $ | (21,374 | ) | $ | (19,697 | ) | $ | (37,661 | ) | $ | (46,117 | ) | |||||
Other adjustments (Note 4) | (36 | ) | — | 177 | — | ||||||||||||
Non-GAAP interest expense, net and other expense, net | $ | (21,410 | ) | $ | (19,697 | ) | $ | (37,484 | ) | $ | (46,117 | ) | |||||
GAAP provision for income taxes | $ | 18,130 | $ | 30,131 | $ | 23,615 | $ | 30,430 | |||||||||
Other adjustments (Note 4) | (17,510 | ) | (29,653 | ) | (20,572 | ) | (29,589 | ) | |||||||||
Non-GAAP provision for income taxes | $ | 620 | $ | 478 | $ | 3,043 | $ | 841 | |||||||||
Condensed Consolidated Balance Sheets Data |
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(in thousands) |
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(unaudited) |
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|
|
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Assets | ||||||||
Cash, cash equivalents and marketable securities | $ | 1,071,436 | $ | 1,042,462 | ||||
Restricted cash and cash equivalents (VIE) (Note 5) | 70,513 | 78,910 | ||||||
Accounts receivable, net | 189,356 | 177,639 | ||||||
Inventories | 66,589 | 57,207 | ||||||
Property and equipment, net | 690,607 | 697,715 | ||||||
Intangible assets and goodwill | 334,724 | 334,724 | ||||||
Other assets | 125,757 | 109,930 | ||||||
Total assets | $ | 2,548,982 | $ | 2,498,587 | ||||
Liabilities and Shareholders' Equity | ||||||||
Other liabilities | $ | 394,870 | $ | 426,482 | ||||
Deferred tax liability | 132,810 | 110,439 | ||||||
Accrued restructuring expense | 12,484 | 15,358 | ||||||
Deferred revenues | 18,879 | 26,010 | ||||||
Capital leases | 51,763 | 58,468 | ||||||
|
472,834 | 473,043 | ||||||
Senior secured term loan | 296,497 | 295,159 | ||||||
Shareholders' equity | 1,168,845 | 1,093,628 | ||||||
Total liabilities and shareholders' equity | $ | 2,548,982 | $ | 2,498,587 | ||||
Common shares outstanding | 247,704 | 246,307 | ||||||
Note 1 : Cost of product revenues in the six months ended
Note 2: The company excludes restructuring expense (income) from
its non-GAAP income (loss) attributable to Vertex. In the three and six
months ended
Note 3: In the three and six months ended
Note 4: In the three and six months ended
Note 5: The company consolidates the financial statements of two
of its collaborators as variable interest entities ("VIEs") as of
ORKAMBI is a combination of lumacaftor and ivacaftor indicated for the treatment of cystic fibrosis (CF) in patients age 12 years and older who are homozygous for the F508del mutation in the CFTR gene. The efficacy and safety of ORKAMBI have not been established in patients with CF other than those homozygous for the F508del mutation.
Worsening of liver function, including hepatic encephalopathy, in patients with advanced liver disease has been reported in some patients with CF while receiving ORKAMBI.
Serious adverse reactions related to elevated transaminases have been reported in patients with CF receiving ORKAMBI and, in some instances, associated with concomitant elevations in total serum bilirubin.
Respiratory events (e.g., chest discomfort, shortness of breath, and chest tightness) were observed more commonly in patients during initiation of ORKAMBI compared to those who received placebo. Clinical experience in patients with percent predicted FEV1 < 40 is limited, and additional monitoring of these patients is recommended during initiation of therapy.
Co-administration of ORKAMBI with sensitive CYP3A substrates or CYP3A substrates with a narrow therapeutic index is not recommended as ORKAMBI may reduce their effectiveness. ORKAMBI may substantially decrease hormonal contraceptive exposure, reducing their effectiveness and increasing the incidence of menstruation-associated adverse reactions. Co-administration with strong CYP3A inducers is not recommended as they may reduce the therapeutic effectiveness of ORKAMBI.
Abnormalities of the eye lens (cataracts) have been reported in pediatric patients treated with ivacaftor, a component of ORKAMBI.
Increased blood pressure has been observed in some patients treated with ORKAMBI. Blood pressure should be monitored periodically in all patients being treated with ORKAMBI.
The most common adverse reactions associated with ORKAMBI include shortness of breath, sore throat, nausea, diarrhea, upper respiratory tract infection, fatigue, chest tightness, increased blood creatinine phosphokinase, rash, flatulence, runny nose, and influenza.
Please see the full prescribing information for ORKAMBI.
KALYDECO is a cystic fibrosis transmembrane conductance regulatory (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients age 2 years and older who have one of the following mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R or R117H.
KALYDECO is not effective in patients with CF with 2 copies of the F508del mutation (F508del/F508del) in the CFTR gene. The safety and efficacy of KALYDECO in children with CF younger than 2 years of age have not been studied. The use of KALYDECO in children under the age of 2 years is not recommended.
High liver enzymes (transaminases; ALT and AST) have been reported in patients with CF receiving KALYDECO.
Use of KALYDECO with medicines that are strong CYP3A inducers substantially decreases exposure of KALYDECO and may diminish effectiveness. Therefore, co-administration is not recommended. The dose of KALYDECO must be adjusted when used concomitantly with strong and moderate CYP3A inhibitors or when used in patients with moderate or severe hepatic disease.
Cases of non-congenital lens opacities/cataracts have been reported in pediatric patients treated with KALYDECO.
The most common side effects associated with KALYDECO include headache; upper respiratory tract infection (common cold), including sore throat, nasal or sinus congestion, and runny nose; stomach (abdominal) pain; diarrhea; rash; nausea; and dizziness.
Please see the full prescribing information for KALYDECO.
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. In addition to our clinical development programs focused on cystic fibrosis, Vertex has more than a dozen ongoing research programs aimed at other serious and life-threatening diseases.
Founded in 1989 in
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,
Conference Call and Webcast
The company will host a conference call and webcast today at
(VRTX-GEN)
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