-Total 2017 CF product revenues of
Key financial results include:
Three Months Ended |
% |
Twelve Months Ended |
% | ||||||||||||||||||||||||
2017 | 2016 | Change | 2017 | 2016 | Change | ||||||||||||||||||||||
(in millions, except per share and percentage data) | |||||||||||||||||||||||||||
ORKAMBI product revenues, net | $ | 365 | $ | 277 | 32% | $ | 1,321 | $ | 980 | 35% | |||||||||||||||||
KALYDECO product revenues, net | $ |
256 |
$ |
177 |
44% | $ |
845 |
$ |
703 |
20% | |||||||||||||||||
TOTAL CF product revenues, net | $ |
621 |
$ |
454 |
37% | $ |
2,165 |
$ |
1,683 |
29% | |||||||||||||||||
GAAP Collaborative revenues | $ | 29 | $ | 1 | n/a | $ | 315 | $ | 2 | n/a | |||||||||||||||||
GAAP net income (loss) | $ | 101 | $ | 33 | 206% | $ | 263 | $ | (112 | ) | n/a | ||||||||||||||||
GAAP net income (loss) per share - diluted | $ | 0.39 | $ | 0.13 | 200% | $ | 1.04 | $ | (0.46 | ) | n/a | ||||||||||||||||
Non-GAAP net income | $ | 158 | $ | 88 | 80% | $ | 495 | $ | 211 | 134% | |||||||||||||||||
Non-GAAP net income per share - diluted | $ | 0.61 | $ | 0.35 | 74% | $ | 1.95 | $ | 0.85 | 129% | |||||||||||||||||
"2017 was an outstanding year for Vertex as we made significant progress across all aspects of our business that moved us closer toward our goal of delivering new medicines that treat the underlying cause of CF for all people with the disease," said
Full-Year 2017 Financial Highlights
Revenues:
Expenses:
Net Income (Loss) Attributable to Vertex:
Cash Position:
Fourth-Quarter 2017 Financial Highlights
Revenues:
Expenses:
Net Income Attributable to Vertex:
2018 Financial Guidance
Vertex today provided full-year 2018 guidance for combined GAAP and non-GAAP R&D and SG&A expenses, as summarized below:
Vertex plans to provide total CF product revenue guidance for the full year of 2018 upon the anticipated approval by the
Stock Repurchase Program
The company today announced that its Board of Directors has authorized a share repurchase program of up to
Purchases may be made through the open market or privately negotiated transactions and may be made pursuant to Rule 10b5-1 plans or other means as determined by Vertex's management and in accordance with the requirements of the
"In 2017, we achieved significant revenues, earnings and cash flow growth, and we expect this will continue as we increase the number of patients we treat with our CF medicines," said
Business Highlights
ORKAMBI
On
In the first quarter of 2018, Vertex plans to submit a New Drug Application (NDA) to the
KALYDECO
On
Based on results from this study, Vertex expects to submit regulatory applications to the
TEZACAFTOR/IVACAFTOR
An NDA for the tezacaftor/ivacaftor combination treatment for people with CF ages 12 and older who have two copies of the F508del mutation or who have at least one residual function mutation that is responsive to tezacaftor/ivacaftor is currently under priority review by the
TRIPLE COMBINATION REGIMENS
In a separate press release today, Vertex announced the selection of two next-generation correctors, VX-659 and VX-445, to advance into Phase 3 development as part of two different triple combination regimens for people with CF. Upon the completion of regulatory discussions, the company plans to initiate a Phase 3 program in the first half of 2018 to evaluate VX-659 in triple combination with tezacaftor and ivacaftor. In addition, Vertex plans to initiate a Phase 3 program in mid-2018 to evaluate VX-445 in triple combination with tezacaftor and VX-561 as a once-daily regimen, pending additional data in the first half of 2018, including Phase 2 data on the combination of VX-445, tezacaftor and VX-561.
SICKLE CELL DISEASE & β-THALASSEMIA
On
For CTX001, CRISPR and Vertex will equally share all research and development costs and profits worldwide. A Clinical Trial Application (CTA) was submitted in
INFLUENZA
During the fourth quarter of 2017, Vertex earned a
In
The pimodivir development program receives funding support from the
PAIN
In the first quarter of 2018, Vertex expects to obtain data from a Phase 2 proof-of-concept study evaluating VX-150, a selective NaV1.8 channel blocker, for the treatment of acute pain following bunionectomy surgery. An additional Phase 2 proof-of-concept study further evaluating VX-150 for the treatment of pain caused by small fiber neuropathy is ongoing.
ONGOING RESEARCH & DEVELOPMENT
Vertex has ongoing development programs for potential medicines aimed at other serious and life-threatening diseases, including VX-210 for the treatment of acute cervical spinal cord injury. In addition, Vertex is progressing additional internal research programs in sickle cell disease, alpha-1 antitrypsin disease, adrenoleukodystrophy, and polycystic kidney disease. The company expects to advance one or more research-stage drug candidates into clinical development in 2018.
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
Fourth-Quarter Results Consolidated Statements of Operations Data (in thousands, except per share amounts) (unaudited) |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
Three Months Ended |
Twelve Months Ended |
||||||||||||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||||||||||||
Revenues: | |||||||||||||||||||||||||
Product revenues, net | $ | 621,228 | $ | 453,882 | $ | 2,165,480 | $ | 1,683,632 | |||||||||||||||||
Royalty revenues | 1,345 | 3,887 | 7,988 | 16,600 | |||||||||||||||||||||
Collaborative revenues (Note 1) | 29,061 | 937 | 315,184 | 1,945 | |||||||||||||||||||||
Total revenues | 651,634 | 458,706 | 2,488,652 | 1,702,177 | |||||||||||||||||||||
Costs and expenses: | |||||||||||||||||||||||||
Cost of product revenues | 83,712 | 59,646 | 272,675 | 206,811 | |||||||||||||||||||||
Royalty expenses | 340 | 836 | 2,444 | 3,649 | |||||||||||||||||||||
Research and development expenses | 306,664 | 248,452 | 1,324,625 | 1,047,690 | |||||||||||||||||||||
Sales, general and administrative expenses | 134,794 | 109,908 | 496,079 | 432,829 | |||||||||||||||||||||
Restructuring expenses | 387 | 224 | 14,246 | 1,262 | |||||||||||||||||||||
Intangible asset impairment charge (Note 2) | — | — | 255,340 | — | |||||||||||||||||||||
Total costs and expenses | 525,897 | 419,066 | 2,365,409 | 1,692,241 | |||||||||||||||||||||
Income from operations | 125,737 | 39,640 | 123,243 | 9,936 | |||||||||||||||||||||
Interest expense, net | (12,547 | ) | (20,439 | ) | (57,550 | ) | (81,432 | ) | |||||||||||||||||
Other (expenses) income, net (Note 2) | (748 | ) | 1,105 | (81,382 | ) | 4,130 | |||||||||||||||||||
Income (loss) from operations before provision for (benefit from) income taxes (Note 2) | 112,442 | 20,306 | (15,689 | ) | (67,366 | ) | |||||||||||||||||||
Provision for (benefit from) income taxes (Note 2) | 10,257 | (7,453 | ) | (107,324 | ) | 16,665 | |||||||||||||||||||
Net income (loss) | 102,185 | 27,759 | 91,635 | (84,031 | ) | ||||||||||||||||||||
(Income) loss attributable to noncontrolling interest (Note 2) | (1,501 | ) | 5,186 | 171,849 | (28,021 | ) | |||||||||||||||||||
Net income (loss) attributable to Vertex | $ | 100,684 | $ | 32,945 | $ | 263,484 | $ | (112,052 | ) | ||||||||||||||||
Amounts per share attributable to Vertex common shareholders: | |||||||||||||||||||||||||
Net income (loss): | |||||||||||||||||||||||||
Basic | $ | 0.40 | $ | 0.13 | $ | 1.06 | $ | (0.46 | ) | ||||||||||||||||
Diluted | $ | 0.39 | $ | 0.13 | $ | 1.04 | $ | (0.46 | ) | ||||||||||||||||
Shares used in per share calculations: | |||||||||||||||||||||||||
Basic | 251,557 | 245,454 | 248,858 | 244,685 | |||||||||||||||||||||
Diluted | 256,804 | 247,757 | 253,225 | 244,685 | |||||||||||||||||||||
Reconciliation of GAAP to Non-GAAP Net Income (Loss) Fourth-Quarter Results (in thousands, except per share amounts) (unaudited) |
|||||||||||||||||||||||
Three Months Ended |
Twelve Months Ended |
||||||||||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||||||||||
GAAP net income (loss) attributable to Vertex | $ | 100,684 | $ | 32,945 | $ | 263,484 | $ | (112,052 | ) | ||||||||||||||
Stock-based compensation expense | 75,402 | 59,082 | 290,736 | 237,705 | |||||||||||||||||||
Concert upfront and transaction expenses (Note 3) | — | — | 165,057 | — | |||||||||||||||||||
Revenues and expenses related to VIEs (Note 2) | — | (4,500 | ) | 14,083 | 54,850 | ||||||||||||||||||
Other collaborative and transaction revenue and expenses (Note 4) | (19,177 | ) | — | (255,747 | ) | 33,000 | |||||||||||||||||
Other adjustments (Note 5) | 941 | 145 | 16,947 | (2,306 | ) | ||||||||||||||||||
Non-GAAP net income attributable to Vertex | $ | 157,850 | $ | 87,672 | $ | 494,560 | $ | 211,197 | |||||||||||||||
Amounts per diluted share attributable to Vertex common shareholders: | |||||||||||||||||||||||
GAAP | $ | 0.39 | $ | 0.13 | $ | 1.04 | $ | (0.46 | ) | ||||||||||||||
Non-GAAP | $ | 0.61 | $ | 0.35 | $ | 1.95 | $ | 0.85 | |||||||||||||||
Shares used in diluted per share calculations: | |||||||||||||||||||||||
GAAP | 256,804 | 247,757 | 253,225 | 244,685 | |||||||||||||||||||
Non-GAAP | 256,804 | 247,757 | 253,225 | 247,276 | |||||||||||||||||||
Reconciliation of GAAP to Non-GAAP Revenues and Expenses Fourth-Quarter Results (in thousands) (unaudited) |
||||||||||||||||||||||
Three Months Ended |
Twelve Months Ended |
|||||||||||||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||||||||||||
GAAP total revenues | $ | 651,634 | $ | 458,706 | $ | 2,488,652 | $ | 1,702,177 | ||||||||||||||
Revenues related to VIEs (Note 2) | (497 | ) | (94 | ) | (43,376 | ) | (944 | ) | ||||||||||||||
Other collaborative and transaction revenue (Note 4) | (28,509 | ) | — | (271,605 | ) | — | ||||||||||||||||
Other adjustments (Note 5) | — | (121 | ) | — | (526 | ) | ||||||||||||||||
Non-GAAP total revenues | $ | 622,628 | $ | 458,491 | $ | 2,173,671 | $ | 1,700,707 | ||||||||||||||
Three Months Ended |
Twelve Months Ended |
|||||||||||||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||||||||||||
GAAP cost of product revenues and royalty expenses | $ | 84,052 | $ | 60,482 | $ | 275,119 | $ | 210,460 | ||||||||||||||
Other adjustments (Note 5) | — | 98 | — | (19 | ) | |||||||||||||||||
Non-GAAP cost of product revenues and royalty expenses | $ | 84,052 | $ | 60,580 | $ | 275,119 | $ | 210,441 | ||||||||||||||
GAAP research and development expenses | $ | 306,664 | $ | 248,452 | $ | 1,324,625 | $ | 1,047,690 | ||||||||||||||
Stock-based compensation expense | (47,045 | ) | (38,383 | ) | (181,900 | ) | (153,451 | ) | ||||||||||||||
Concert upfront payment (Note 3) | — | — | (160,000 | ) | — | |||||||||||||||||
Expenses related to VIEs (Note 2) | (967 | ) | (2,971 | ) | (7,729 | ) | (6,762 | ) | ||||||||||||||
Other collaborative and transaction expenses (Note 4) | (9,282 | ) | — | (14,966 | ) | (33,000 | ) | |||||||||||||||
Other adjustments (Note 5) | (136 | ) | (13 | ) | (544 | ) | 3,293 | |||||||||||||||
Non-GAAP research and development expenses | $ | 249,234 | $ | 207,085 | $ | 959,486 | $ | 857,770 | ||||||||||||||
GAAP sales, general and administrative expenses | $ | 134,794 | $ | 109,908 | $ | 496,079 | $ | 432,829 | ||||||||||||||
Stock-based compensation expense | (28,357 | ) | (20,699 | ) | (108,836 | ) | (84,254 | ) | ||||||||||||||
Concert transaction expenses (Note 3) | — | — | (5,057 | ) | — | |||||||||||||||||
Expenses related to VIEs (Note 2) | (465 | ) | (1,160 | ) | (3,826 | ) | (4,160 | ) | ||||||||||||||
Other collaborative and transaction expenses (Note 4) | (50 | ) | — | (892 | ) | — | ||||||||||||||||
Other adjustments (Note 5) | (418 | ) | (127 | ) | (2,157 | ) | (232 | ) | ||||||||||||||
Non-GAAP sales, general and administrative expenses | $ | 105,504 | $ | 87,922 | $ | 375,311 | $ | 344,183 | ||||||||||||||
Combined non-GAAP R&D and SG&A expenses | $ | 354,738 | $ | 295,007 | $ | 1,334,797 | $ | 1,201,953 | ||||||||||||||
Three Months Ended |
Twelve Months Ended |
|||||||||||||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||||||||||||
GAAP interest expense, net and other expense, net | $ | (13,295 | ) | $ | (19,334 | ) | $ | (138,932 | ) | $ | (77,302 | ) | ||||||||||
(Income) expenses related to VIEs (Note 2) | (4 | ) | (32 | ) | 76,503 | 108 | ||||||||||||||||
Non-GAAP interest expense, net and other expense, net | $ | (13,299 | ) | $ | (19,366 | ) | $ | (62,429 | ) | $ | (77,194 | ) | ||||||||||
GAAP provision for (benefit from) income taxes | $ | 10,257 | $ | (7,453 | ) | $ | (107,324 | ) | $ | 16,665 | ||||||||||||
Income taxes related to VIEs (Note 2) | 2,432 | 3,320 | 114,090 | (16,743 | ) | |||||||||||||||||
Non-GAAP provision for (benefit from) income taxes | $ | 12,689 | $ | (4,133 | ) | $ | 6,766 | $ | (78 | ) |
Condensed Consolidated Balance Sheets Data (in thousands) (unaudited) |
|||||||||||
Assets | |||||||||||
Cash, cash equivalents and marketable securities | $ | 2,088,666 | $ | 1,434,557 | |||||||
Restricted cash and cash equivalents (VIE) (Note 2) | 1,489 | 47,762 | |||||||||
Accounts receivable, net | 281,343 | 200,364 | |||||||||
Inventories | 111,830 | 77,604 | |||||||||
Property and equipment, net | 789,437 | 698,362 | |||||||||
Intangible assets and goodwill (Note 2) | 79,384 | 334,724 | |||||||||
Other assets | 193,865 | 103,414 | |||||||||
Total assets | $ | 3,546,014 | $ | 2,896,787 | |||||||
Liabilities and Shareholders' Equity | |||||||||||
Accounts payable and accruals | $ | 517,955 | $ | 376,700 | |||||||
Other liabilities | 415,501 | 260,984 | |||||||||
Deferred tax liability (Note 2) | 6,341 | 134,063 | |||||||||
Construction financing lease obligation | 563,911 | 486,849 | |||||||||
Debt | — | 300,000 | |||||||||
Shareholders' equity | 2,042,306 | 1,338,191 | |||||||||
Total liabilities and shareholders' equity | $ | 3,546,014 | $ | 2,896,787 | |||||||
Common shares outstanding | 253,253 | 248,301 | |||||||||
Note 1: In the three months ended
Note 2: The company consolidated the financial statements of Parion as a VIE during 2016 and through
In the third quarter of 2017, the company determined that the value of Parion's pulmonary ENaC platform had become impaired and that the fair value of the intangible asset was zero as of
As of
Note 3: In
Note 4: In the three months ended
Note 5: In the twelve months ended
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 mutation in their CF gene that is responsive to KALYDECO. Patients should talk to their doctor to learn if they have an indicated CF gene mutation. 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 and anti-anxiety medicines triazolam or midazolam; the immunosuppressant medicines cyclosporin, everolimus, sirolimus, or tacrolimus; or St. John's wort.
Before taking ORKAMBI, patients should tell their doctor about all their medical conditions, including if they: have or have had liver problems; have kidney problems; have had an organ transplant; or are using birth control. Hormonal contraceptives, including oral, injectable, transdermal, or implantable forms 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.
ORKAMBI can cause serious side effects, including:
Worsening of liver function in people with severe liver disease. The worsening of liver function can be serious or cause death. Patients should talk to their doctor if they have been told they have liver disease as their doctor may need to adjust the dose of ORKAMBI.
High liver enzymes in the blood, which can be a sign of liver injury. 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.
Breathing problems such as shortness of breath or chest tightness in patients when starting ORKAMBI, especially in patients who have poor lung function. If a patient has poor lung function, their doctor may monitor them more closely when starting ORKAMBI.
An increase in blood pressure in some people receiving ORKAMBI. The patient's doctor should monitor their blood pressure during treatment with ORKAMBI.
Abnormality of the eye lens (cataract) in some children and adolescents receiving ORKAMBI. For children and adolescents, the patient's doctor should perform eye examinations before and during treatment with ORKAMBI to look for cataracts.
The most common side effects of ORKAMBI include: breathing problems, such as shortness of breath and/or chest tightness; nausea; diarrhea; gas; increase in a certain muscle enzyme called creatinine phosphokinase; common cold, including sore throat, stuffy or runny nose; fatigue; flu or flu-like symptoms; rash; irregular, missed, or abnormal periods (menses) and increase in the amount of menstrual bleeding.
Side effects seen in children are similar to those seen in adults and adolescents. Additional common side effects seen in children include: cough with sputum, stuffy nose, headache, stomach pain, and increase in sputum.
Please click here to see the full Prescribing Information for ORKAMBI.
About Vertex
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases.
Founded in 1989 in
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,
Conference Call and Webcast
The company will host a conference call and webcast today at
(VRTX-E)
View source version on businesswire.com: http://www.businesswire.com/news/home/20180131006107/en/
Vertex Contacts:
Investors:
or
or
or
Media:
617-341-6992
mediainfo@vrtx.com
Source:
News Provided by Acquire Media