Cambridge, MA, February 1, 2007– Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported consolidated financial results for the quarter and year ended December 31, 2006.
“2006 was characterized by significant progress across our business, and in particular by advances in the clinical program for our lead investigational hepatits C virus protease inhibitor telaprevir,” stated Joshua Boger, Ph.D., President and Chief Executive Officer of Vertex Pharmaceuticals. “The initiation of Phase 3 clinical development for telaprevir is our primary objective for 2007, and we are now positioned to build Vertex on telaprevir.”
“We are investing and building our capabilities in key areas necessary to support the advancement of the Company – clinical development, regulatory affairs, quality control, and commercial supply chain management,” continued Dr. Boger. “Our projected investment in these activities in 2007 is supported by our strong financial profile as we enter 2007.”
Full Year Results
For the year ended December 31, 2006, the Company’s net loss on
a GAAP basis was $206.9 million, or $1.83 per share. This included stock-based
compensation expense of approximately $39.1 million, restructuring expense
of approximately
$3.7 million, loss on exchange of convertible subordinated notes of $5.2
million, and gains related to an investment of approximately $11.2 million,
and a cumulative effect of a change in accounting principle of $1.0 million.
The net loss on a GAAP basis for the year ended December 31, 2005 was
$203.4 million, or $2.28 per share. The 2005 GAAP net loss includes stock-based
compensation expense of approximately $4.6 million, restructuring expense
of approximately $8.1 million, and loss on exchange of convertible subordinated
notes of $48.2 million.
The non-GAAP loss, before certain charges and gains for the year ended December 31, 2006 was $171.2 million, or $1.51 per share, compared to a non-GAAP loss, before charges, of $142.4 million, or $1.60 per share for the year ended December 31, 2005. The increase in the Company’s 2006 non-GAAP loss was significantly influenced by, among other things, increased development investment as the Company continued to advance its proprietary drug candidates.
Total revenues for the year ended December 31, 2006 were $216.4 million compared to $160.9 million for 2005. The increase in revenues is primarily due to revenue recognized from development activities in collaboration with Janssen Pharmaceutica and Merck, which offsets a decline in revenue from the Company’s research collaborations.
Research and development (R&D) expenses for the year ended December 31, 2006 were $371.7 million, including $32.0 million of stock-based compensation, compared to $248.5 million, including $3.6 million of stock-based compensation, for 2005. The increase primarily relates to development investment to support the global Phase 2b clinical development program, as well as to the Company’s initial commercial inventory investment for telaprevir (VX-950) and to increased charges for stock-based compensation compared to the prior year, as a result of the adoption of FAS 123R on January 1, 2006.
Sales, general and administrative (SG&A) expenses for the year ended December 31, 2006 were $57.9 million, including $7.1 million of stock-based compensation, compared to $44.0 million, including $1.1 million of stock-based compensation, for 2005. This increase reflects building of infrastructure to support the advancement of the business.
Other income, net, for the year ended December 31, 2006 was $15.1 million, compared to other expense, net, of $5.3 million for 2005. This increase resulted from increased investment balances, and the Company’s reduction of outstanding debt in 2005 and higher investment returns.
At December 31, 2006, Vertex had approximately $761.8 million in cash, cash equivalents and other investments. This amount includes the up-front payment of $165.0 million received from Janssen Pharmaceutica in July and proceeds from the Company’s $330.0 million equity financing completed in September. Vertex ended 2006 with $42.1 million in principal amount of convertible debt due September 2007 and $59.6 million in principal amount of convertible debt due February 2011. The 2011 convertible debt has a conversion price of $14.94 and is callable commencing in February 2007. On February 2, 2007 Vertex intends to call that debt for redemption in March 2007 in accordance with the terms of the indentures governing the 2011 convertible debt. Vertex expects that the holders of notes evidencing that debt will choose to convert their notes into common stock at the applicable conversion rate rather than accept redemption, and that Vertex will therefore issue an aggregate of approximately 4.0 million shares of common stock in full satisfaction of its payment obligations under the 2011 convertible notes. Any notes so converted will no longer be outstanding.
Key 2006 Achievements and 2007 Objectives
Full Year 2007 Financial Guidance
This section contains forward-looking guidance about the financial outlook
for Vertex Pharmaceuticals.
“In 2007, we are focused on maintaining a strong financial profile that will enable us to continue to invest in late-stage development and commercial activities for telaprevir,” said Ian Smith, Executive Vice President and Chief Financial Officer of Vertex. “Our increased 2007 loss guidance compared to 2006 is primarily due to our need to significantly invest in commercial supply to support markets where we expect to launch telaprevir. We remain committed to managing our capital and resources, commensurate with the risk and advancement of telaprevir.”
Loss: Vertex anticipates a non-GAAP loss for 2007, excluding restructuring charges and stock-based compensation expense, in the range of $300 to $330 million. Vertex expects that the full year 2007 GAAP net loss will be in the range of $360 to $390 million. The 2007 GAAP net loss includes an estimate of stock-based compensation expense of approximately $55 million, and restructuring expense of approximately $5 million as a result of imputed interest charges relating to the restructuring accrual.
Revenues: Vertex expects that full year 2007 total revenue will be in the range of $280 to $320 million. This includes:
Research and Development (R&D) Expense: The Company expects that R&D expense will be in the range of $560 to $600 million for 2007, inclusive of approximately $45 million of stock-based compensation expense. This R&D expense includes approximately $110 to $130 million of commercial supply investment for telaprevir, which is considered an expense due to telaprevir’s stage of development.
Sales, General and Administrative (SG&A) Expense: Vertex expects SG&A expense to be in the range of $80 to $90 million in 2007, inclusive of approximately $10.0 million of stock-based compensation expense.
Cash, Cash Equivalents and Other Investments: Vertex expects cash, cash equivalents and available for sale securities to be in excess of $450 million at the end of 2007. In 2007, Vertex expects to continue to seek to manage its convertible debt obligations.
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 full year 2006 and 2005 loss and guidance
for 2007 loss excluding, in each case, restructuring charges, stock-based
compensation expense, loss on exchange of convertible subordinated notes
and net gains related to an investment, which in each case results in
a non-GAAP financial measure. 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 and are important in comparing current results
with prior period results. 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 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,
inflammation, autoimmune diseases, cancer, pain and bacterial infection.
Vertex co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.
Lexiva is a registered trademark of the GlaxoSmithKline group of companies.
Special Note Regarding Forward-looking Statements
This press release contains forward-looking statements, including statements
that Vertex expects that (i) it is positioned to build the Company
on telaprevir; (ii) initiation of Phase 3 clinical trials for telaprevir
will be its primary objective for 2007; (iii) it will invest and build
capabilities in clinical development, regulatory affairs, quality control
and commercial supply chain management to support advancement of the
Company, and that projected investments in these activities in 2007
will be supported by a strong financial profile as the Company enters
2007; (iv) on February 2, 2007, it will call the outstanding Convertible
Senior Subordinated Notes due 2011 for redemption in March 2007; (v)
holders of 2011 Notes will choose to convert their 2011 Notes into
common stock rather than accept redemption, and the Company will issue
approximately 4.0 million shares of common stock upon conversion of
the 2011 Notes; (vi) PROVE 3 will be enrolled and conducted as described;
(vii) PROVE 3 will increase to more than 1,000 the number of patients
enrolled in telaprevir clinical trials; (viii) it will complete enrollment
in PROVE 3 by the end of the second quarter of 2007; (ix) clinical
results from the global Phase 2b PROVE program will provide important
information supporting the design and initiation of Phase 3 clinical
trials of telaprevir in the second half of 2007; (x) clinical data
disclosures in 2007 from the Phase 2b PROVE program will occur principally
at medical conferences; (xi) it will expand clinical development of
telaprevir into important HCV sub-populations, and that its collaborator
Tibotec will undertake clinical development in patients with genotype
2 and genotype 3 HCV infection; (xii) it will initiate in 2007 a clinical
trial exploring twice-daily dosing of telaprevir; (xiii) in 2007, it
will manufacture registration batches of telaprevir and will begin
building an inventory of commercial supply; (xiv) the current PROVE
clinical program has the potential to generate sufficient safety and
efficacy data in a broad range of genotype 1 HCV patients, along with
safety data from the Phase 3 program, to support an NDA filing for
telaprevir in 2008; (xv) discussions with regulatory authorities that
are planned for mid-2007 will define the registration pathways and
timelines for regulatory filings for telaprevir worldwide; (xvi) depending
on results from the Thorough QTc study and Phase 2a clinical trial
of VX-702, it will initiate a larger 6-month Phase 2 clinical trial
of VX-702 on a background of methotrexate; (xvii) the Phase 2 clinical
trial for VX-680 will enroll 270 patients; (xviii) it will advance
VX-883 in preclinical development and initiate a Phase 1 clinical trial
of VX-883 in 2007; (xix) it will be able to invest in late-stage development
and commercial activities for telaprevir; (xx) the Company’s
projected 2007 annual loss, revenues, R&D expense, commercial supply
investment, SG&A expense and cash position, will be within the
ranges stated above in the Company’s financial guidance; and
(xxi) the Company’s estimates of its stock-based compensation
expenses will be as stated above. 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 not allow the Company’s planned
trials to proceed as designed, due to varying interpretations of existing
and expected data or disagreements over trial design or for other reasons,
that the Company’s current plans are to build its organization
based on telaprevir, which is an investigational drug candidate in
Phase 2b clinical trials, that enrollment may be more difficult or
slower than the Company currently anticipates or that planned clinical
trials may not start when planned due to regulatory issues, site startup
delays, availability of clinical trial material or other reasons, that
regulatory authorities will require more extensive data for a telaprevir
NDA filing thus delaying the filing, that one or more of the Company’s
assumptions underlying its revenue expectations -- including clinical
and scientific progress that could lead to milestone payments under
existing collaboration agreements or other payments under new collaborations
-- or its expense expectations -- including estimates of the variables
that go into determining stock-based compensation expenses -- will
not be realized, or that Vertex will be unable to realize one or more
of its financial objectives for 2007 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 Vertex 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. Vertex disclaims any obligation
to update the information contained in this press release as new data
become available.
Vertex Pharmaceuticals Incorporated
2006 Fourth Quarter and Twelve Month Results
Consolidated Statements of Operations Data
(In thousands, except per share amounts)
(Unaudited)
Note 1: Financial results are provided both in accordance with generally accepted accounting principles (GAAP) in the United States and using certain non-GAAP financial measures. These results are provided as a complement to the results in accordance with GAAP because management believes these non-GAAP measures help indicate underlying trends in the Company’s business, and uses these non-GAAP financial measures to establish budgets and operational goals that are communicated internally and externally, to manage the Company’s business and to evaluate its performance.
Note 2: For the three and twelve months ended December 31, 2006, the Company incurred $10.1 million and $39.1 million, respectively, in stock compensation expense of which $8.3 million and $32.0 million, respectively, is included in research and development expenses and $1.8 million and $7.1 million, respectively, is included in sales, general and administrative expenses. Stock compensation expense includes costs associated with restricted stock, stock option awards, and employee stock purchase shares, which were recorded in connection with provisions of FAS 123®, “Share-Based Payment.” FAS 123® requires companies to record stock-based payments in the financial statements using a fair value method. The Company adopted FAS 123® on a modified prospective basis beginning January 1, 2006. For the three and twelve months ended December 31, 2005, the Company recorded $1.6 million and $4.6 million, respectively, of stock compensation expense relating to restricted stock awards.
Note 3: FAS 123® requires the Company to recognize expense only for shares expected to vest, and this results in the Company being required to estimate forfeitures on grant date. During the twelve months ended December 31, 2006 the Company recorded a $1.0 million benefit due to the cumulative effect of estimating forfeitures on the grant date rather than recording them as they occur.
Note 4: For the three and twelve months ended December 31, 2006, the Company incurred restructuring expense charges of $1.0 million and $3.7 million, respectively. These charges are primarily a result of the imputed interest charge related to the restructuring liability.
For the three and twelve months ended December 31, 2005, the Company incurred restructuring charges. The charge for the three months ended December 31, 2005 was $6.4 million, which includes estimated incremental net ongoing lease obligations as well as an imputed interest cost relating to the restructuring accrual. For the twelve months ended December 31, 2005, the Company recorded $8.1 million of net restructuring expense which includes a credit for reversing a portion of the restructuring liability related to the space that Vertex decided to occupy, offset by estimated incremental net ongoing lease obligations for the remainder of the space and imputed interest costs on the restructuring liability.
The expense and the related liability have been estimated in accordance with FASB 146 “Accounting for Costs Associated with Exit or Disposal Activities” and are reviewed quarterly for changes in circumstances.
Note 5: In the third quarter 2006, the Company exchanged approximately 4.1 million shares of the Company’s common stock for approximately $58.3 million in aggregate principal amount of outstanding 5.75% Convertible Senior Subordinated Notes due 2011, plus accrued interest. As a result of the exchange, the Company incurred a non-cash charge of approximately $5.2 million related to the incremental shares issued in the transaction over the number that would have been issued upon the conversion of the notes under the original terms.
In the fourth quarter 2005, holders of 5.75% Convertible Subordinated Notes due 2011 exchanged $114.5 million in aggregate principal amount plus accrued interest, for approximately 8.1 million shares of common stock. As a result of the exchange, a non-cash charge of approximately $11.9 million was incurred. This charge is related to the incremental shares issued in the transaction over the number that would have been issued upon conversion of the notes under the original terms.
In the third quarter 2005, holders of 5% Convertible Subordinated Notes due 2007 exchanged $40.5 million in aggregate principal amount plus accrued interest, for approximately 2.5 million shares of common stock. As a result of the exchange, a non-cash charge of approximately $36.3 million was incurred. This charge is related to the incremental shares issued in the transaction over the number that would have been issued upon conversion of the notes under the original terms.
Note 6: In the third quarter 2006, the Company owned warrants to purchase shares of Altus common stock. In accordance with FAS 133, “Accounting for Derivative Instruments and Hedging Activities,” the Company recorded the warrants on the balance sheets at a fair market value of $19.1 million and recorded an unrealized gain on the fair market value of the warrants of $4.3 million. In October 2006, the Company sold warrants for approximately $18.3 million, resulting in a realized loss of $0.7 million.
In the third quarter of 2006, the Company sold 817,749 shares of Altus Pharmaceuticals common stock for approximately $11.7 million, resulting in a realized gain of approximately $7.7 million.
Note 7: In the third quarter 2006, the Company completed a public offering of 10,000,000 shares of common stock, including the underwriters’ allotment of 900,000 shares, at a price of $33.00 per share. This transaction resulted in net proceeds of approximately $313.3 million. The net proceeds include an underwriting discount of approximately $15.7 million and other expenses that were recorded as an offset to additional paid-in-capital.
Vertex Pharmaceuticals Incorporated
2006 Fourth Quarter Results
Condensed Consolidated Balance Sheets Data
(In thousands)
(Unaudited)
Conference Call and Webcast: Full Year 2006 Financial
Results:
Vertex Pharmaceuticals will host a conference call today, February 1,
2007 at 5:00 p.m. ET to review financial results and recent developments.
This call will be broadcast via the Internet at www.vrtx.com in the investor
center. Alternatively, to listen to the call on the telephone, dial (800)
374-0296 (U.S. and Canada) or (706) 634-2224 (International). Vertex
is also providing a podcast MP3 file available for download on the Vertex
website, www.vrtx.com.
The call will be available for replay via telephone commencing February 1, 2007 at 8:00 p.m. ET running through 5:00 p.m. ET on February 8, 2007. The replay phone number for the U.S. and Canada is (800) 642-1687. The international replay number is (706) 645-9291 and the conference ID number is 6562724. Following the live webcast, an archived version will be available on Vertex’s website until 5:00 p.m. ET on February 15, 2007.
Vertex Contacts:
Lynne H. Brum, Vice President, Strategic Communications, (617) 444-6614
Michael Partridge, Director, Corporate Communications, (617) 444-6108
Lora Pike, Manager, Investor Relations, (617) 444-6755