CAMBRIDGE, Mass., Oct 26, 2009 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reviewed recent business and clinical progress and reported consolidated financial results for the quarter ended September 30, 2009.
"Vertex has made significant advancements across its business and expects to enter 2010 in a strong financial position that will enable the continued investment in late-stage development programs in hepatitis C virus infection and cystic fibrosis," said Matthew Emmens, Chairman, President and Chief Executive Officer of Vertex Pharmaceuticals. "We remain focused on the completion of the telaprevir Phase 3 registration program and are on track to submit a telaprevir New Drug Application in the second half of 2010. In addition, we believe ongoing clinical trials of telaprevir and of our novel HCV polymerase inhibitor VX-222 will enable the initiation of the first combination trial of these two compounds in HCV patients in the coming months - underscoring our commitment to improve patient care in HCV."
Mr. Emmens continued, "Later this week, we expect to present final SVR data from Study C208 at the AASLD meeting in Boston showing the potential for telaprevir to be dosed twice-daily as part of a response-guided treatment regimen. Our confidence in telaprevir's competitive profile remains high, and we look forward to the presentation of data from C208 and other clinical trials in the coming days.
"In cystic fibrosis, we recently completed enrollment in a Phase 2 trial of VX-809, our novel CFTR corrector compound, and we continue to enroll patients across the three trials of the Phase 3 registration program for VX-770, our novel CFTR potentiator. VX-770 and VX-809 aim to address the underlying defective protein responsible for this orphan disorder, with the goal of enabling cystic fibrosis patients to live a more normal life," Mr. Emmens said.
Broad Commitment to Hepatitis C
Phase 3 registration program ongoing:ADVANCE, ILLUMINATE and REALIZE trials
SVR data from telaprevir twice-daily dosing to be presented at AASLD this week
Additional telaprevir clinical studies in patients who failed prior HCV therapy
On track to initiate STAT-C combination trial as early as Q4 2009
Additional HCV compounds in clinical development
AASLD
Broad Program Targeting Cystic Fibrosis
Potentiator compound VX-770 in Phase 3 registration program
Phase 2a trial of corrector compound VX-809 completes enrollment
Potential to Combine VX-770 and VX-809
Additional Pipeline Progress - VX-509 (JAK3 inhibitor)
Business Development Activities Completed in Third Quarter add $260M to Cash Position
Third Quarter Results
For the quarter ended September 30, 2009, the Company's GAAP net loss was $149.6 million, or $0.84 per share, including stock-based compensation and executive transition expenses of $21.9 million and restructuring expenses of $0.8 million, compared to a GAAP net loss for the quarter ended September 30, 2008 of $130.0 million, or $0.93 per share, including stock-based compensation expense of $14.5 million and restructuring expenses of $0.9 million.
The non-GAAP loss, before stock-based compensation and executive transition expenses and restructuring expenses, for the quarter ended September 30, 2009 was $126.9 million, or $0.71 per share, compared to $114.7 million, or $0.82 per share, for the quarter ended September 30, 2008. The increase in the Company's 2009 non-GAAP loss was principally attributable to a decrease in collaborative revenues and increased costs related to the building of capabilities, including an increase in the number of employees and our commercial investments, to support advancement of telaprevir toward potential launch.
Total revenues for the quarter ended September 30, 2009 were $25.0 million, compared to $31.6 million for the third quarter of 2008.
Research and development (R&D) expenses for the quarter ended September 30, 2009 were $132.1 million, compared to $131.7 million for the third quarter of 2008.
Sales, general and administrative (SG&A) expenses for the quarter ended September 30, 2009 were $36.6 million, compared to $25.4 million for the third quarter of 2008. This increase primarily reflects building of capabilities, including an increase in the number of employees and our commercial investments, to support advancement of telaprevir toward potential launch.
Interest expense, net, for the quarter ended September 30, 2009 was $1.3 million, compared to interest income, net, of $0.6 million for the third quarter of 2008. This decrease resulted primarily from a lower level of investment portfolio yields reflecting the broader economic environment.
At September 30, 2009, Vertex had $856.6 million in cash, cash equivalents and marketable securities. This includes proceeds of $227.2 million received in the third quarter of 2009 from the completion of business development activities. As part of these business development activities, an additional $32.8 million was received on October 1, 2009, which is not reflected in Vertex's September 30, 2009 cash position. Vertex has $144.0 million of remaining 2013 convertible notes outstanding, with a conversion price of $23.14 per share. The 2013 convertible notes are callable on or after February 15, 2010.
Full Year 2009 Financial Guidance
This section contains forward-looking guidance about the financial outlook for Vertex Pharmaceuticals.
The Company is today reiterating its guidance for 2009 year-end cash, cash equivalents and marketable securities and for non-GAAP and GAAP net loss, as provided on September 30, 2009.
Non-GAAP Financial Measures
In this press release, Vertex's financial results are provided both in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures. In particular, Vertex provides its third quarter 2009 and 2008 loss, and guidance for its projected 2009 loss, excluding restructuring expense, acquisition-related expenses, executive transition expenses, stock-based compensation expense, and loss on exchange of convertible subordinated notes. 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 other non-GAAP financial results to GAAP financial results is included in the attached financial statements.
About Vertex
Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is focused on viral diseases, cystic fibrosis, inflammation, autoimmune diseases, cancer and pain. Vertex co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.
Lexivais a registered trademark of the GlaxoSmithKline group of companies.
PEGASYS(R) is a registered trademark of Hoffman La Roche.
PEGINTRON(R) is a registered trademark of Schering Corporation.
Special Note Regarding Forward-looking Statements
This press release contains forward-looking statements, including statements regarding (i) the Company's Phase 3 registration programs in hepatitis C and CF being on track; (ii) the plan to present final SVR data from Study C208, and data from other clinical trials of telaprevir, at AASLD; (iii) the expectation that the Company will enter 2010 in a strong financial position that will enable the continued investment in late-stage development programs in hepatitis C and CF; (iv) the Company being on track to submit a New Drug Application for telaprevir in the second half of 2010; (v) the belief that ongoing clinical trials of telaprevir and of the novel HCV polymerase inhibitor VX-222 will enable the initiation of the first combination trial of these two compounds in HCV patients in the coming months; (vi) the potential for telaprevir to be dosed twice-daily as part of a response-guided treatment regimen; (vii) the Company's confidence in telaprevir's competitive profile remaining high; (viii) VX-770 and VX-809 aiming to address the underlying defective protein responsible for CF, with the goal of enabling CF patients to live a more normal life; (ix) expectations regarding when sustained viral response data will be available from the Company's ADVANCE, ILLUMINATE and REALIZE clinical trials; (x) the aim of the ILLUMINATE clinical trial being to characterize whether there is an additional benefit to extending treatment from 24 weeks to 48 weeks in treatment-naïve patients who achieve eRVR; (xi) seeking to advance HCV therapy through the development of novel combinations of Specifically-Targeted Antiviral Therapies for hepatitis C (STAT-Cs); (xii) the expectation that the Company will obtain data from ongoing clinical trials of VX-222 in the fourth quarter of 2009, which could enable the initiation of a combination trial of telaprevir and VX-222 in patients with genotype 1 HCV as early as the fourth quarter of 2009; (xiii) the expectation that data from the first STAT-C combination study of telaprevir and VX-222 will become available by mid-2010; (xiv) the ENDEAVOR registration program being designed to evaluate the utility of VX-770 across different age groups and genotypes, (xv) the clinical trial designs, including expected numbers of patients, primary and secondary endpoints and the treatment durations, for the STRIVE, ENVISION and DISCOVER clinical trials; (xvi) the expectation that STRIVE will complete enrollment in the first quarter of 2010; (xvii) the expectation that the Company will obtain data from the ongoing clinical trial of VX-809 in the first quarter of 2010; (xviii) in vitro data providing a rationale to explore the clinical potential for combining VX-770 and VX-809 in patients with CF and that a clinical trial evaluating this combination could begin in the second half of 2010; (xix) the plan to initiate a Phase 2 proof-of-concept clinical trial of VX-509 in patients with moderate to severe rheumatoid arthritis in the first quarter of 2010; (xx) the belief that the planned VX-509 clinical trial will result in interim clinical data, including measurements of safety, tolerability and clinical activity, being available in the second half of 2010; (xxi) the plan to pursue collaborative opportunities for VX-509 with major pharmaceutical companies and the expectation that any ongoing or future out-licensing activities for VX-509 will conclude after the receipt of clinical data from the planned Phase 2 clinical trial; (xxii) the possibility that VX-509 may have broad potential for the treatment of multiple immune-mediated inflammatory diseases; and (xxiii) the Company's guidance that its 2009 year-end cash, cash equivalents and marketable securities position and its 2009 non-GAAP and GAAP net losses will be as provided on September 30, 2009. While the Company believes the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, that the outcomes for each of its planned clinical trials and studies, and in particular its planned clinical trials of telaprevir, may not be favorable, that regulatory authorities may require supplemental clinical trials in order to support registration of telaprevir in any particular indication, that there may be varying interpretations of data produced by one or more of our clinical trials, that enrollment may be more difficult or slower than we currently anticipate or that planned clinical trials may not start when planned, that regulatory authorities will require more extensive data for a telaprevir NDA filing than currently expected, that the Company may not be able to successfully develop combination therapies involving telaprevir and VX-222 or VX-770 and VX-809, that the Company may not complete additional business development and outlicensing activities, that one or more of the Company's assumptions underlying its revenue expectations or its expense expectations -- including estimates of the variables that go into determining stock-based compensation expenses -- will not be realized, or that the Company will be unable to realize one or more of its financial objectives for 2009 due to unexpected and costly program delays, or any number of other financial, technical or collaboration considerations, that unexpected costs associated with one or more of the Company's programs will necessitate a reduction in its investment in other programs or a change in the Company's financial projections, that future competitive or other market factors may adversely affect the commercial potential for the Company's product candidates in HCV or other potential indications, that due to scientific, medical or technical developments, the Company's drug discovery efforts will not ultimately result in commercial products or assets that can generate revenue, that the Company will be unable to enter into new collaborative relationships on acceptable terms, and other risks listed under Risk Factors in Vertex's annual report and quarterly reports filed with the Securities and Exchange Commission and available through the Company's website at www.vrtx.com. The Company disclaims any obligation to update the information contained in this press release as new information becomes available.
Vertex Pharmaceuticals Incorporated | ||||||||
Three Months Ended |
Nine Months Ended | |||||||
2009 | 2008 | 2009 | 2008 | |||||
Revenues: | ||||||||
Royalty revenues (Note 6) | $7,834 | $7,763 | $19,891 | $28,355 | ||||
Collaborative and other R&D revenues | 17,123 | 23,846 | 48,109 | 114,338 | ||||
Total revenues | 24,957 | 31,609 | 68,000 | 142,693 | ||||
Costs and expenses: | ||||||||
Royalty expenses (Note 6) | 3,712 | 4,194 | 10,555 | 11,471 | ||||
Research and development expenses (R&D) (Note 7) | 132,132 | 131,728 | 415,044 | 377,574 | ||||
Sales, general & administrative expenses (SG&A) (Note 7) | 36,572 | 25,430 | 97,618 | 71,810 | ||||
Restructuring expense (Note 3) | 774 | 885 | 4,283 | 2,683 | ||||
Acquisition-related expenses (Note 2) | --- | --- | 7,793 | --- | ||||
Total costs and expenses | 173,190 | 162,237 | 535,293 | 463,538 | ||||
Loss from operations | (148,233) | (130,628) | (467,293) | (320,845) | ||||
Net interest income (expense) (Note 5) | (1,332) | 584 | (3,947) | 3,326 | ||||
Loss on exchange of convertible subordinated notes (Note 5) | --- | --- | (12,294) | --- | ||||
Net loss | $(149,565) | $(130,044) | $ (483,534) | $ (317,519) | ||||
Basic and diluted net loss per common share | $ (0.84) | $ (0.93) | $ (2.86) | $ (2.30) | ||||
Basic and diluted weighted-average number of common shares outstanding | 178,735 | 140,109 | 169,137 | 137,788 | ||||
Non-GAAP Loss and Loss per Common Share Reconciliation |
Three Months Ended |
Nine Months Ended | ||||||
2009 | 2008 | 2009 | 2008 | |||||
GAAP Net Loss | $(149,565) | $(130,044) | $ (483,534) | $ (317,519) | ||||
Pro Forma Adjustments: | ||||||||
Stock-based compensation and executive transition expenses included in R&D (Note 7): | $13,509 | $11,423 | $54,244 | $35,392 | ||||
Stock-based compensation and executive transition expenses included in SG&A (Note 7) | 8,365 | 3,062 | 19,985 | 8,758 | ||||
Total stock-based compensation and executive transition expenses | $21,874 | $14,485 | $74,229 | $44,150 | ||||
Loss on exchange of convertible subordinated notes (Note 5) | --- | --- | 12,294 | --- | ||||
Restructuring expense (Note 3) | 774 | 885 | 4,283 | 2,683 | ||||
Acquisition-related expenses (Note 2) | --- | --- | 7,793 | --- | ||||
Non-GAAP Loss | $(126,917) | $(114,674) | $ (384,935) | $ (270,686) | ||||
Basic and diluted non-GAAP loss per common share | $ (0.71) | $ (0.82) | $ (2.28) | $ (1.96) |
Note 1: On September 30, 2009, the Company entered into two financing transactions that resulted in aggregate payments to the Company of $155.0 million. These financing transactions related to future milestone payments pursuant to the Company's collaboration with Janssen Pharmaceutica, N.V. ("Janssen"). In the first transaction, the Company issued notes which are secured by $155.0 million in future telaprevir milestone payments that the Company is eligible to receive from Janssen for the filing, approval and launch of telaprevir in the European Union (the "2012 Notes"). The 2012 Notes have a face value of $155.0 million, were issued at a discount and do not carry an explicit interest rate. The 2012 Notes mature on October 31, 2012, subject to earlier mandatory redemption to the extent milestone events are achieved prior to October 31, 2012. In the second transaction, the Company sold rights to $95.0 million of potential future milestone payments that the Company is eligible to receive from Janssen for the launch of telaprevir in the European Union. The Company received $122.2 million of the $155.0 million on September 30, 2009 and the remainder on October 1, 2009.
Note 2: On March 12, 2009, the Company acquired ViroChem Pharma Inc. ("ViroChem"), a biotechnology company based in Canada. The Company paid an aggregate purchase price of $100.0 million in cash and 10,733,527 shares of the Company's common stock in order to acquire ViroChem. All of the assets acquired and liabilities assumed in the transaction are recognized at their acquisition-date fair values, while transaction costs and restructuring costs associated with the transaction are expensed as incurred.
The $390.6 million purchase price for ViroChem is based on the acquisition-date fair value of the consideration transferred, which was calculated based on the opening price of the Company's common stock of $27.07 per share on March 12, 2009. The difference between the aggregate purchase price and the fair value of assets acquired and liabilities assumed is allocated to goodwill.
Note 3: The Company recorded restructuring expense of $0.8 million for the three months ended September 30, 2009 compared to $0.9 million for the three months ended September 30, 2008. The Company recorded restructuring expense of $4.3 million for the nine months ended September 30, 2009 compared to $2.7 million for the nine months ended September 30, 2008. The restructuring expense in all periods included imputed interest cost related to the restructuring liability. The increase in restructuring expense for the nine months ended September 30, 2009 compared to the nine months ended September 30, 2008 was primarily the result of a revision, in the first quarter of 2009, of certain key estimates and assumptions about facility operating costs for the remaining period of the lease commitment, for which there was no corresponding revision in the nine months ended September 30, 2008. The lease restructuring liability was $33.4 million as of September 30, 2009. The expense and the related liability are reviewed quarterly for changes in circumstances.
Note 4: In February 2009, the Company completed a public offering of 10,000,000 shares of common stock, at a price of $32.00 per share. This transaction resulted in net proceeds of $313.3 million to the Company.
In September 2008, the Company completed a public offering of 8,625,000 shares of common stock, at a price of $25.50 per share. This transaction resulted in net proceeds of $217.4 million to the Company.
In February 2008, the Company completed a public offering of 6,900,000 shares of common stock at a price of $17.14 per share. This transaction resulted in net proceeds of $112.7 million to the Company.
Note 5: In February 2008, the Company completed an offering of $287.5 million aggregate principal amount of 4.75% convertible senior subordinated notes due February 2013 (the "2013 Notes"). The 2013 Notes are convertible, at the option of the holder, into common stock at a price equal to approximately $23.14 per share, subject to adjustment under certain circumstances. The 2013 Notes bear interest at the rate of 4.75% per year, and the Company is required to make semi-annual interest payments on the outstanding principal balance of the notes on February 15 and August 15 of each year. This transaction resulted in net proceeds of $278.6 million to the Company.
In June 2009, holders of the 2013 Notes exchanged $143.5 million in aggregate principal amount of the 2013 Notes, plus interest, for 6.6 million shares of newly issued common stock. As a result of this exchange, the Company incurred a non-cash charge of $12.3 million in the second quarter of 2009. The charge corresponds to the value of additional shares issued in the transactions over the number of shares that would have been issued upon conversion of the 2013 Notes at the conversion prices set forth therein.
Note 6: In the first quarter of 2008, the Company recognized royalty revenues based on actual and estimated net sales of Lexiva/Telzir and Agenerase by GlaxoSmithKline plc under the Company's 1993 license agreement with GlaxoSmithKline plc. In the second quarter of 2008, the Company sold the Company's right to receive future royalty payments, net of sub-royalty payments due to a third party, arising from sales of Lexiva/Telzir and Agenerase under the Company's license agreement with GlaxoSmithKline plc in return for a one-time cash payment of $160.0 million. After the sale of the Company's right to receive future royalty payments, the Company recognizes deferred revenues relating to the $160.0 million one-time cash payment from the purchaser over the term of our agreement with GlaxoSmithKline plc.
Note 7: Certain amounts in prior year's financial statements have been reclassified to conform to the current presentation. The reclassifications had no effect on the reported net loss.
Condensed Consolidated Balance Sheets Data (in thousands) (unaudited) | |||||
September 30,
2009 |
December 31,
2008 | ||||
Assets | |||||
Cash, cash equivalents and marketable securities | $856,610 | $832,101 | |||
Receivable related to milestone transactions (Note 1) | 32,783 | --- | |||
Other current assets | 24,673 | 35,480 | |||
Property and equipment, net | 62,444 | 68,331 | |||
Restricted cash | 30,313 | 30,258 | |||
Intangible assets (Note 2) | 525,900 | --- | |||
Goodwill (Note 2) | 26,102 | --- | |||
Other non-current assets (Note 5) | 14,666 | 14,309 | |||
Total assets | $1,573,491 | $980,479 | |||
Liabilities and Stockholders' Equity | |||||
Other current liabilities | $150,350 | $172,567 | |||
Accrued restructuring expense (Note 3) | 33,358 | 34,064 | |||
Deferred tax liability (Note 2) | 162,503 | --- | |||
Deferred revenues (Note 6) | 319,536 | 247,474 | |||
Convertible notes (due 2013)(Note 5) | 144,000 | 287,500 | |||
Liability related to milestone transactions (Note 1) | 155,000 | --- | |||
Stockholders' equity (Notes 2, 4 & 5) | 608,744 | 238,874 | |||
Total liabilities and stockholders' equity | $1,573,491 | $980,479 | |||
Common shares outstanding (Notes 2, 4 & 5) | 180,899 | 151,245 | |||
Conference Call and Webcast: Third Quarter Financial Results:
Vertex Pharmaceuticals will host a conference call and webcast today, Monday, October 26, 2009 at 5:00 p.m. ET to review financial results and recent developments. This call and webcast will be broadcast via the Internet at www.vrtx.com. It is suggested that webcast participants go to the web site at least 10 minutes in advance of the call to ensure that they can access the slides. The link to the webcast is available on the Events and Presentations button on the home page.
To listen to the call on the telephone, dial (888) 219-1459 (U.S. and Canada) (913) 312-0695 (International). Vertex is also providing a podcast MP3 file available for download on the Vertex website at www.vrtx.com.
The call will be available for replay via telephone commencing October 26, 2009 at 8:00 p.m. ET running through 5:00 p.m. ET on November 2, 2009. The replay phone number for the U.S. and Canada is (888) 203-1112. The international replay number is (719) 457-0820 and the conference ID number is 7430858. Following the live webcast, an archived version will be available on Vertex's website until 5:00 p.m. EDT on November 9, 2009.
Vertex's press releases are available at www.vrtx.com.
(VRTX-GEN)
SOURCE: Vertex Pharmaceuticals Incorporated
Vertex Contacts:
Investors
Michael Partridge, 617-444-6108
or
Lora Pike, 617-444-6755
or
Media
Zachry Barber, 617-444-6470
Copyright Business Wire 2009