Vertex Reports Third Quarter 2016 Financial Results
-Third quarter 2016 cystic fibrosis product revenues of
Three Months Ended |
||||||||||||||
2016 | 2015 | % Change | ||||||||||||
(in millions, except per share and percentage data) | ||||||||||||||
ORKAMBI product revenues, net | $ | 234 | $ | 131 | 79 | % | ||||||||
KALYDECO product revenues, net | $ |
176 |
$ |
166 |
6 | % | ||||||||
TOTAL CF product revenues, net | $ |
410 |
$ |
297 |
38 | % | ||||||||
GAAP net loss | $ | (42 | ) | $ | (95 | ) | (56 | )% | ||||||
GAAP net loss per share | $ | (0.17 | ) | $ | (0.39 | ) | (56 | )% | ||||||
Non-GAAP net income (loss) | $ | 40 | $ | (32 | ) | N/A | ||||||||
Non-GAAP net income (loss) per share | $ | 0.16 | $ | (0.13 | ) | N/A |
"Vertex continues to make significant progress with the key growth drivers for our business - increasing the number of people being treated with ORKAMBI and KALYDECO, expanding the number of people eligible for these medicines through label-expansions and developing new medicines to treat potentially all people with CF in the future," said
Vertex today reviewed recent progress from across its CF program:
ORKAMBI
Data from Phase 3 efficacy study to support approval in children ages 6 to 11 in
Tezacaftor (VX-661) in Combination with Ivacaftor
Enrollment complete in two Phase 3 studies of tezacaftor (VX-661); data expected in first half of 2017: Vertex has now completed enrollment in two of three ongoing Phase 3 studies of the investigational combination of tezacaftor and ivacaftor. Enrollment is complete in the Phase 3 study in people ages 12 and older who have two copies of the F508del mutation and also in the Phase 3 study in people ages 12 and older who have one F508del mutation and one residual function mutation. Data from both studies are expected in the first half of 2017. The Phase 3 study of tezacaftor in combination with ivacaftor in people with one F508del mutation and one gating mutation is expected to complete enrollment in early 2017. Vertex plans to submit a New Drug Application (NDA) to the
Next-Generation Correctors
Planned initiation of Phase 2 studies in CF patients: In a separate press release issued today, Vertex announced that it plans to initiate two Phase 2 studies to evaluate the next-generation correctors VX-440 and VX-152 in triple combination regimens with tezacaftor (VX-661) and ivacaftor in people with cystic fibrosis (CF). Both studies are expected to start by the end of 2016. Additional details on the design of these studies were provided today in a separate press release.
Additional next-generation correctors moving into clinical development: Vertex also today announced that it plans to begin a Phase 1 study of VX-659, the company's third next-generation corrector, by the end of 2016 and to advance a fourth next-generation corrector into clinical development in 2017. Additional details were provided today in a separate press release.
Third Quarter 2016 Financial Highlights
Revenues:
- Net product revenues from ORKAMBI were
$234.0 million compared to$130.8 million for the third quarter of 2015. ORKAMBI was launched in theU.S. inJuly 2015 . - Net product revenues from KALYDECO were
$175.6 million , compared to$165.9 million for the third quarter of 2015.
Expenses:
- GAAP operating expenses were
$435.5 million compared to$379.8 million for the third quarter of 2015. Non-GAAP operating expenses (combined non-GAAP R&D and SG &A) were$298.0 million compared to$277.7 million for the third quarter of 2015. The increases were primarily driven by increased costs related to the progression of our CF pipeline and to increased investment in global commercial support for the launch of ORKAMBI. - GAAP R&D expenses were
$275.4 million compared to$246.3 million for the third quarter of 2015. Non-GAAP R&D expenses were$214.0 million compared to$201.6 million for the third quarter of 2015. The increases were primarily driven by increased investment to progress our portfolio of CF medicines. - GAAP SG&A expenses were
$106.1 million compared to$99.8 million for the third quarter of 2015. Non-GAAP SG&A expenses were$84.0 million compared to$76.1 million for the third quarter of 2015. The increases were primarily driven by increased investment to support the global launch of ORKAMBI.
Net Income (Loss) Attributable to Vertex:
- GAAP net loss was
$(41.8) million , or$(0.17) per diluted share, compared to GAAP net loss of$(95.1) million , or$(0.39) per diluted share, for the third quarter of 2015. Non-GAAP net income was$40.1 million , or$0.16 per diluted share, compared to a non-GAAP net loss of$(31.9) million , or$(0.13) per diluted share, for the third quarter of 2015.
Cash Position:
- As of
September 30, 2016 , Vertex had$1.13 billion in cash, cash equivalents and marketable securities compared to$1.04 billion in cash, cash equivalents and marketable securities as ofDecember 31, 2015 . - As of
September 30, 2016 , Vertex had$300 million outstanding from a credit agreement, which was refinanced onOctober 13, 2016 to lower the company's interest expense. The$300 million outstanding under the new credit agreement matures in the fourth quarter of 2021.
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&
- ORKAMBI: The company continues to expect total 2016 product revenues for ORKAMBI of
$950 to$990 million . - KALYDECO: The company continues to expect total 2016 product revenues for KALYDECO of
$685 to$705 million . 2016 guidance for KALYDECO currently excludes any revenues related to the potential approval of KALYDECO for people in theU.S. who have residual function mutations. - Operating Expenses (Combined Non-GAAP R&
D and SG &A Expenses): Vertex continues to expect that its combined non-GAAP R&D and SG &A expenses in 2016 will be in the range of$1.18 to$1.23 billion . Vertex's expected non-GAAP R&D and SG &A expenses exclude stock-based compensation expense and certain other expenses.
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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Three Months Ended |
Nine Months Ended |
|||||||||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||||||||
Revenues: | ||||||||||||||||||||
Product revenues, net | $ | 409,689 | $ | 302,511 | $ | 1,229,750 | $ | 593,774 | ||||||||||||
Royalty revenues | 3,835 | 5,759 | 12,713 | 17,628 | ||||||||||||||||
Collaborative revenues | 259 | 1,546 | 1,008 | 2,999 | ||||||||||||||||
Total revenues | 413,783 | 309,816 | 1,243,471 | 614,401 | ||||||||||||||||
Costs and expenses: | ||||||||||||||||||||
Cost of product revenues (Note 1) | 53,222 | 30,269 | 147,165 | 55,059 | ||||||||||||||||
Royalty expenses | 855 | 1,691 | 2,813 | 6,068 | ||||||||||||||||
Research and development expenses | 275,370 | 246,284 | 802,238 | 685,741 | ||||||||||||||||
Sales, general and administrative expenses | 106,055 | 99,772 | 322,921 | 280,026 | ||||||||||||||||
Restructuring expenses | 8 | 1,826 | 1,038 | 682 | ||||||||||||||||
Total costs and expenses | 435,510 | 379,842 | 1,276,175 | 1,027,576 | ||||||||||||||||
Loss from operations | (21,727 | ) | (70,026 | ) | (32,704 | ) | (413,175 | ) | ||||||||||||
Interest expense, net | (20,140 | ) | (21,134 | ) | (60,993 | ) | (63,552 | ) | ||||||||||||
Other income (expenses), net | (167 | ) | (1,326 | ) | 3,025 | (5,025 | ) | |||||||||||||
Loss from operations before provision for income taxes | (42,034 | ) | (92,486 | ) | (90,672 | ) | (481,752 | ) | ||||||||||||
Provision for income taxes | 503 | 1,330 | 24,118 | 31,760 | ||||||||||||||||
Net loss | (42,537 | ) | (93,816 | ) | (114,790 | ) | (513,512 | ) | ||||||||||||
Loss (income) attributable to noncontrolling interest | 696 | (1,333 | ) | (33,207 | ) | 30,909 | ||||||||||||||
Net loss attributable to Vertex | $ | (41,841 | ) | $ | (95,149 | ) | $ | (147,997 | ) | $ | (482,603 | ) | ||||||||
Amounts per share attributable to Vertex common shareholders: | ||||||||||||||||||||
Net loss: | ||||||||||||||||||||
Basic and diluted | $ | (0.17 | ) | $ | (0.39 | ) | $ | (0.61 | ) | $ | (2.00 | ) | ||||||||
Shares used in per share calculations: | ||||||||||||||||||||
Basic and diluted | 244,920 | 241,969 | 244,529 | 240,749 |
Reconciliation of GAAP to Non-GAAP Net Income (Loss)
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Three Months Ended |
Nine Months Ended |
|||||||||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||||||||
GAAP loss attributable to Vertex | $ | (41,841 | ) | $ | (95,149 | ) | $ | (147,997 | ) | $ | (482,603 | ) | ||||||||
Stock-based compensation expense | 61,209 | 65,734 | 178,623 | 186,379 | ||||||||||||||||
Real estate restructuring costs and income (Note 2) | 121 | 214 | 696 | (2,186 | ) | |||||||||||||||
HCV related revenues and costs (Note 3) | (2,448 | ) | (7,734 | ) | (3,257 | ) | (18,207 | ) | ||||||||||||
Other adjustments (Notes 4 and 5) | 23,090 | 5,007 | 92,460 | 5,631 | ||||||||||||||||
Non-GAAP net income (loss) attributable to Vertex | $ | 40,131 | $ | (31,928 | ) | $ | 120,525 | $ | (310,986 | ) | ||||||||||
Amounts per diluted share attributable to Vertex common shareholders: | ||||||||||||||||||||
GAAP | $ | (0.17 | ) | $ | (0.39 | ) | $ | (0.61 | ) | $ | (2.00 | ) | ||||||||
Non-GAAP | $ | 0.16 | $ | (0.13 | ) | $ | 0.49 | $ | (1.29 | ) | ||||||||||
Shares used in diluted per share calculations: | ||||||||||||||||||||
GAAP | 244,920 | 241,969 | 244,529 | 240,749 | ||||||||||||||||
Non-GAAP | 248,009 | 241,969 | 247,433 | 240,749 |
Reconciliation of GAAP to Non-GAAP Revenues and Expenses
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Three Months Ended |
Nine Months Ended |
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2016 | 2015 | 2016 | 2015 | |||||||||||||||||
GAAP total revenues | $ | 413,783 | $ | 309,816 | $ | 1,243,471 | $ | 614,401 | ||||||||||||
HCV related revenues (Note 3) | (43 | ) | (6,415 | ) | (405 | ) | (15,378 | ) | ||||||||||||
Other adjustments (Note 4) | (203 | ) | (1,105 | ) | (850 | ) | (1,379 | ) | ||||||||||||
Non-GAAP total revenues | $ | 413,537 | $ | 302,296 | $ | 1,242,216 | $ | 597,644 | ||||||||||||
Three Months Ended |
Nine Months Ended |
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2016 | 2015 | 2016 | 2015 | |||||||||||||||||
GAAP cost of product revenues and royalty expenses | $ | 54,077 | $ | 31,960 | $ | 149,978 | $ | 61,127 | ||||||||||||
HCV related costs (Note 3) | 16 | 1,546 | (117 | ) | (422 | ) | ||||||||||||||
Non-GAAP cost of product revenues and royalty expenses | $ | 54,093 | $ | 33,506 | $ | 149,861 | $ | 60,705 | ||||||||||||
GAAP research and development expenses | $ | 275,370 | $ | 246,284 | $ | 802,238 | $ | 685,741 | ||||||||||||
Stock-based compensation expense | (39,980 | ) | (44,700 | ) | (115,068 | ) | (124,550 | ) | ||||||||||||
HCV related costs (Note 3) | 2,465 | (294 | ) | 3,342 | 707 | |||||||||||||||
Other adjustments (Note 4) | (23,889 | ) | 298 | (36,828 | ) | (1,222 | ) | |||||||||||||
Non-GAAP research and development expenses | $ | 213,966 | $ | 201,588 | $ | 653,684 | $ | 560,676 | ||||||||||||
GAAP sales, general and administrative expenses | $ | 106,055 | $ | 99,772 | $ | 322,921 | $ | 280,026 | ||||||||||||
Stock-based compensation expense | (21,229 | ) | (21,034 | ) | (63,555 | ) | (61,829 | ) | ||||||||||||
HCV related costs (Note 3) | (76 | ) | (43 | ) | (106 | ) | 2,807 | |||||||||||||
Other adjustments (Note 4) | (758 | ) | (2,578 | ) | (2,999 | ) | (3,725 | ) | ||||||||||||
Non-GAAP sales, general and administrative expenses | $ | 83,992 | $ | 76,117 | $ | 256,261 | $ | 217,279 | ||||||||||||
Combined non-GAAP R& |
$ | 297,958 | $ | 277,705 | $ | 909,945 | $ | 777,955 | ||||||||||||
Three Months Ended |
Nine Months Ended |
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2016 | 2015 | 2016 | 2015 | |||||||||||||||||
GAAP interest expense, net and other expense, net | $ | (20,307 | ) | $ | (22,460 | ) | $ | (57,968 | ) | $ | (68,577 | ) | ||||||||
Other adjustments (Note 4) | (36 | ) | — | 138 | — | |||||||||||||||
Non-GAAP interest expense, net and other expense, net | $ | (20,343 | ) | $ | (22,460 | ) | $ | (57,830 | ) | $ | (68,577 | ) | ||||||||
GAAP provision for income taxes | $ | 503 | $ | 1,330 | $ | 24,118 | $ | 31,760 | ||||||||||||
Other adjustments (Note 4) | 509 | (777 | ) | (20,063 | ) | (30,367 | ) | |||||||||||||
Non-GAAP provision for income taxes | $ | 1,012 | $ | 553 | $ | 4,055 | $ | 1,393 |
Condensed Consolidated Balance Sheets Data
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Assets | |||||||||
Cash, cash equivalents and marketable securities | $ | 1,128,441 | $ | 1,042,462 | |||||
Restricted cash and cash equivalents (VIE) (Note 5) | 58,420 | 78,910 | |||||||
Accounts receivable, net | 182,229 | 173,838 | |||||||
Inventories | 71,799 | 57,207 | |||||||
Property and equipment, net | 687,613 | 697,715 | |||||||
Intangible assets and goodwill | 334,724 | 334,724 | |||||||
Other assets | 141,612 | 113,731 | |||||||
Total assets | $ | 2,604,838 | $ | 2,498,587 | |||||
Liabilities and Shareholders' Equity | |||||||||
Other liabilities | $ | 434,142 | $ | 426,482 | |||||
Deferred tax liability | 133,270 | 110,439 | |||||||
Accrued restructuring expense | 7,237 | 15,358 | |||||||
Deferred revenues | 15,806 | 26,010 | |||||||
Capital leases | 49,491 | 58,468 | |||||||
Construction financing lease obligation | 468,500 | 473,043 | |||||||
Senior secured term loan | 297,751 | 295,159 | |||||||
Shareholders' equity | 1,198,641 | 1,093,628 | |||||||
Total liabilities and shareholders' equity | $ | 2,604,838 | $ | 2,498,587 | |||||
Common shares outstanding | 248,029 | 246,307 |
Note 1 : Cost of product revenues in the nine months ended
Note 2: The company excludes restructuring expense (income) from its non-GAAP income (loss) attributable to Vertex. In the three and nine months ended
Note 3: In the three and nine months ended
Note 4: In the three months ended
Note 5: The company consolidates the financial statements of two of its collaborators as variable interest entities ("VIEs") as of
INDICATION AND IMPORTANT SAFETY INFORMATION FOR KALYDECO® (ivacaftor)
KALYDECO (ivacaftor) is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 2 years and older who have one of the following mutations in their CF gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H. KALYDECO is not for use in people with CF due to other mutations in the CF gene. KALYDECO is not effective in patients with CF with two copies of the F508del mutation (F508del/F508del) in the CF gene. It is not known if KALYDECO is safe and effective in children under 2 years of age.
Patients should not take KALYDECO if they are taking certain medicines or herbal supplements such as: the antibiotics rifampin or rifabutin; seizure medications such as phenobarbital, carbamazepine, or phenytoin; or St. John's wort.
Before taking KALYDECO, patients should tell their doctor if they: have liver or kidney problems; drink grapefruit juice, or eat grapefruit or
KALYDECO may affect the way other medicines work, and other medicines may affect how KALYDECO works. Therefore the dose of KALYDECO may need to be adjusted when taken with certain medications. Patients should especially tell their doctor if they take antifungal medications such as ketoconazole, itraconazole, posaconazole, voriconazole, or fluconazole; or antibiotics such as telithromycin, clarithromycin, or erythromycin.
KALYDECO can cause dizziness in some people who take it. Patients should not drive a car, use machinery, or do anything that needs them to be alert until they know how KALYDECO affects them. Patients should avoid food containing grapefruit or
KALYDECO can cause serious side effects including:
High liver enzymes in the blood have been reported in patients receiving KALYDECO. The patient's doctor will do blood tests to check their liver before starting KALYDECO, every 3 months during the first year of taking KALYDECO, and every year while taking KALYDECO. For patients who have had high liver enzymes in the past, the doctor may do blood tests to check the liver more often. Patients should call their doctor right away if they have any of the following symptoms of liver problems: pain or discomfort in the upper right stomach (abdominal) area; yellowing of their skin or the white part of their eyes; loss of appetite; nausea or vomiting; or dark, amber-colored urine.
Abnormality of the eye lens (cataract) has been noted in some children and adolescents receiving KALYDECO. The patient's doctor should perform eye examinations prior to and during treatment with KALYDECO to look for cataracts. The most common side effects include headache; upper respiratory tract infection (common cold), which includes sore throat, nasal or sinus congestion, and runny nose; stomach (abdominal) pain; diarrhea; rash; nausea; and dizziness.
These are not all the possible side effects of KALYDECO.
Please click here to see the full Prescribing Information for KALYDECO (ivacaftor).
INDICATION AND IMPORTANT SAFETY INFORMATION FOR ORKAMBI® (lumacaftor/ivacaftor) TABLETS
ORKAMBI is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have two copies of the F508del mutation (F508del/F508del) in their CFTR gene. ORKAMBI should only be used in these patients. It is not known if ORKAMBI is safe and effective in children under 6 years of age.
Patients should not take ORKAMBI if they are taking certain medicines or herbal supplements, such as: the antibiotics rifampin or rifabutin; the seizure medicines phenobarbital, carbamazepine, or phenytoin; the sedatives/anti-anxiety medicines triazolam or midazolam; the immunosuppressant medicines everolimus, sirolimus, or tacrolimus; or St. John's wort.
Before taking ORKAMBI, patients should tell their doctor if they: have or have had liver problems; have kidney problems; have had an organ transplant; are using birth control (hormonal contraceptives, including oral, injectable, transdermal or implantable forms). Hormonal contraceptives should not be used as a method of birth control when taking ORKAMBI. Patients should tell their doctor if they are pregnant or plan to become pregnant (it is unknown if ORKAMBI will harm the unborn baby) or if they are breastfeeding or planning to breastfeed (it is unknown if ORKAMBI passes into breast milk).
ORKAMBI may affect the way other medicines work and other medicines may affect how ORKAMBI works. Therefore, the dose of ORKAMBI or other medicines may need to be adjusted when taken together. Patients should especially tell their doctor if they take: antifungal medicines such as ketoconazole, itraconazole, posaconazole, or voriconazole; or antibiotics such as telithromycin, clarithromycin, or erythromycin.
When taking ORKAMBI, patients should tell their doctor if they stop ORKAMBI for more than 1 week as the doctor may need to change the dose of ORKAMBI or other medicines the patient is taking. It is unknown if ORKAMBI causes dizziness. Patients should not drive a car, use machinery, or do anything requiring alertness until the patient knows how ORKAMBI affects them.
ORKAMBI can cause serious side effects including:
High liver enzymes in the blood, which can be a sign of liver injury, have been reported in patients receiving ORKAMBI. The patient's doctor will do blood tests to check their liver before they start ORKAMBI, every three months during the first year of taking ORKAMBI, and annually thereafter. The patient should call the doctor right away if they have any of the following symptoms of liver problems: pain or discomfort in the upper right stomach (abdominal) area; yellowing of the skin or the white part of the eyes; loss of appetite; nausea or vomiting; dark, amber-colored urine; or confusion.
Respiratory events such as shortness of breath or chest tightness were observed in patients when starting ORKAMBI. If a patient has poor lung function, their doctor may monitor them more closely when starting ORKAMBI.
An increase in blood pressure has been seen in some patients treated with ORKAMBI. The patient's doctor should monitor their blood pressure during treatment with ORKAMBI.
Abnormality of the eye lens (cataract) has been noted in some children and adolescents receiving ORKAMBI and ivacaftor, a component of ORKAMBI. For children and adolescents, the patient's doctor should perform eye examinations prior to and during treatment with ORKAMBI to look for cataracts.
The most common side effects of ORKAMBI include: shortness of breath and/or chest tightness; upper respiratory tract infection (common cold), including sore throat, stuffy or runny nose; gastrointestinal symptoms including nausea, diarrhea, or gas; rash; fatigue; flu or flu-like symptoms; increase in muscle enzyme levels; and irregular, missed, or abnormal menstrual periods and heavier bleeding.
Please click here to see the full Prescribing Information for ORKAMBI.
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,
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