UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549
FORM 8-K CURRENT REPORT
Pursuant to Section 13 or 15(d) of the |
Date of Report: July 27, 2006
(Date of earliest event reported)
Theravance, Inc.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction
of incorporation)
000-30319
(Commission File Number)
94-3265960
(IRS Employer
Identification Number)
901 Gateway Boulevard,
South San Francisco, CA
(Address of principal executive offices)
94080
(Zip Code)
650-808-6000
(Registrant's telephone number, including area code)
Not Applicable
(Former Name or Former Address, if changed since last report)
Item 2.02. Results of Operations and Financial Condition The information in this Current Report (including Exhibit 99.1) is being furnished and shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in this Current Report (including Exhibit 99.1) shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing. On July 27, 2006, Theravance, Inc. issued a press release regarding its financial results for the quarter ended June 30, 2006. A copy of the press release is furnished as Exhibit 99.1 to this Current Report.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits 99.1 Press Release of Theravance, Inc. dated July 27, 2006
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Dated: July 27, 2006 |
THERAVANCE, INC.
By: /s/ Michael W. Aguiar |
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Exhibit No. | Description |
99.1 | Press Release of Theravance, Inc. dated July 27, 2006 |
SOUTH SAN FRANCISCO, CA -- 07/27/2006 -- Theravance, Inc. (NASDAQ: THRX) reported today its financial results for the second quarter ended June 30, 2006. The net loss for the second quarter of 2006 was $41.5 million compared to $31.7 million during the same period of 2005, an increase of $9.8 million. The higher loss was primarily due to increased research and development costs associated with telavancin Phase 3 clinical programs and additional stock-based compensation expense associated with the adoption of the Financial Accounting Standards Board's Statement No. 123 (revised 2004), "Share-Based Payment" (SFAS 123(R)). Research and development costs of $40.8 million during the second quarter 2006 were $7.9 million lower than the quarter ended March 31, 2006, due to lower clinical trial enrollment costs.
"I am pleased with the company's execution during the quarter," said Rick E Winningham, Chief Executive Officer. "We recently completed enrollment in our telavancin Phase 3 complicated skin and skin structure program and expect to report top line data later in Q3. We now have two compounds in a Phase 2b clinical program in our Beyond Advair Collaboration, with a third compound progressing well in Phase 2. In addition, we continue to make progress with our other programs."
Program Highlights
Bacterial Infections Programs:
Telavancin
We have completed enrollment in our Phase 3 studies for the treatment of patients with serious Gram-positive complicated skin and skin structure infections (cSSSI), including those due to resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA), and we received a milestone payment of $25.0 million under our agreement with Astellas Pharma Inc. (Astellas). Enrollment included over 1,800 patients, of which more than one third had confirmed methicillin-resistant infections.
Our Phase 3 program for the treatment of resistant Gram-positive hospital-acquired pneumonia continues to progress. Completion of enrollment in this program will likely occur during the first half of 2007.
For the upcoming Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), sixteen telavancin abstracts have been submitted and accepted.
Heterodimer
We recently completed single-dose Phase 1 studies and have initiated multiple-dose Phase 1 studies of our unique heterodimer antibiotic TD-1792. This compound combines the antibacterial activities of a glycopeptide and a beta-lactam in one molecule.
Respiratory Programs:
Beyond Advair
On June 12, 2006, the company announced that GlaxoSmithKline (GSK) enrolled the first patient in the Beyond Advair Phase 2b clinical program with compound 642444 ('444), an investigational long-acting beta2 agonist (LABA) in patients with mild to moderate asthma. The collaboration now has two compounds in this phase of development: '444, a GSK-discovered compound, and 159797 ('797), a Theravance-discovered compound.
Long-Acting Muscarinic Antagonist (LAMA) and Bifunctional Muscarinic Antagonist-Beta2 Agonist (MABA)
Our LAMA and MABA programs for the treatment of chronic obstructive pulmonary disease continue to progress.
Gastrointestinal (GI) Motility Dysfunction Program:
We have completed single- and multiple-dose Phase 1 studies of TD-5108 and are currently evaluating the results.
Financial Results
Revenue:
Revenue was $4.8 million in the second quarter of 2006 compared to $2.9 million in the same period of 2005. This increase was primarily due to higher amortization of upfront and milestone payments received from the company's partnerships with GSK and Astellas. All payments received to date under these agreements are being amortized over the relevant performance periods rather than recognized when received.
Research and Development:
Research and development spending for the second quarter of 2006 increased
to $40.8 million compared to $28.9 million for the same period of 2005 and
decreased by $7.9 million compared to $48.7 million in the first quarter of
2006. The year-over-year increase was primarily driven by higher external
research and development costs associated with our two Phase 3 programs for
telavancin and the impact of
SFAS 123(R). Total research and development
stock-based compensation expense for the three months ended June 30, 2006
was $3.3 million compared to $0.8 million for the same period in 2005.
Total external research and development costs were $22.9 million in the
second quarter of 2006 compared to $14.4 million in the same period of
2005.
General and Administrative:
General and administrative costs for the second quarter of 2006 increased to $8.9 million compared to $7.2 million in the same period of 2005 primarily driven by the adoption of SFAS 123(R) and higher employee costs. Total general and administrative stock-based compensation expense for the second quarter of 2006 was $3.5 million compared to $0.6 million for the same period last year.
Cash and Cash Equivalents:
Cash, cash equivalents and marketable securities totaled $293.5 million as of June 30, 2006, a decrease of $5.3 million during the quarter. This decrease was primarily due to cash usage of approximately $38.3 million during the second quarter offset by the receipt of milestone payments of $33.0 million, including $25.0 million from Astellas and $8.0 million from GSK.
Conference Call and Webcast Information
As previously announced, the company has scheduled a conference call to discuss this announcement beginning at 5:00 p.m. Eastern Daylight Time today. To participate in the live call by telephone, please dial 800-810-0924 from the U.S., or 913-981-4900 for international callers. Those interested in listening to the conference call live via the internet may do so by visiting the company's web site at www.theravance.com. To listen to the live call, please go to the web site 15 minutes prior to its start to register, download, and install any necessary audio software.
A replay of the conference call will be available on the company's web site for 30 days through August 26, 2006. An audio replay will also be available through 11:59 p.m. Eastern Daylight Time on August 26, 2006 by dialing 888-203-1112 from the U.S., or 719-457-0820 for international callers, and entering confirmation code 6744312.
About Theravance
Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates. Theravance is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections and gastrointestinal motility dysfunction. Of the five programs in development, two are in late stage -- its telavancin program focusing on treating serious Gram-positive bacterial infections with Astellas Pharma Inc. and the Beyond Advair collaboration with GlaxoSmithKline. By leveraging its proprietary insight of multivalency to drug discovery focused on validated targets, Theravance is pursuing a next generation drug discovery strategy designed to discover superior medicines in large markets. For more information, please visit the company's web site at www.theravance.com.
THERAVANCE®, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE® are registered trademarks of Theravance, Inc.
This press release contains and the conference call will contain certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives and future events. Theravance intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Exchange Act and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to the goals, timing and expected results of clinical and preclinical studies, statements regarding the potential benefits and mechanisms of action of drug candidates, the enabling capabilities of Theravance's approach to drug discovery and its proprietary insights, statements concerning expectations for product candidates through development and commercialization and projections of revenue and other financial items. These statements are based on the current estimates and assumptions of the management of Theravance as of the date of this press release and the conference call and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance to be materially different from those reflected in its forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to delays or difficulties in commencing or completing clinical and preclinical studies, the potential that results of clinical or preclinical studies indicate product candidates are unsafe, ineffective, inferior or not superior, delays or failure to achieve regulatory approvals, and risks of collaborating with third parties to develop and commercialize products. These and other risks are described in greater detail under the heading "Risk Factors" contained in Theravance's 10-Q filed with the Securities and Exchange Commission (SEC) on May 8, 2006, and the risks discussed in our other filings with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance assumes no obligation to update its forward-looking statements.
THERAVANCE, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share data) Three Months Ended Six Months Ended June 30, June 30, -------------------- -------------------- 2006 2005 2006 2005 --------- --------- --------- --------- (unaudited) (unaudited) Revenue (1) $ 4,837 $ 2,913 $ 9,133 $ 5,670 Operating expenses: Research and development (2) 40,751 28,889 89,459 59,086 General and administrative (2) 8,899 7,215 16,173 12,851 --------- --------- --------- --------- Total operating expenses 49,650 36,104 105,632 71,937 --------- --------- --------- --------- Loss from operations (44,813) (33,191) (96,499) (66,267) Interest and other income, net 3,474 1,619 6,359 3,437 Interest expense (136) (144) (287) (337) --------- --------- --------- --------- Net loss $ (41,475) $ (31,716) $ (90,427) $ (63,167) ========= ========= ========= ========= Net loss per share (3) $ (0.70) $ (0.60) $ (1.55) $ (1.19) ========= ========= ========= ========= Shares used in computing net loss per share (3) 59,440 53,163 58,185 53,025 ========= ========= ========= ========= (1) Revenue includes amounts from GSK, a related party, of $3.3 million and $6.4 million for the three months and six months ended June 30, 2006, respectively, and $2.9 million and $5.7 million for the three months and six months ended June 30, 2005, respectively. (2) Amounts include stock-based compensation expense for the three months and six months ended June 30 as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, ----------------- ----------------- 2006 2005 2006 2005 -------- -------- -------- -------- (unaudited) (unaudited) Research and development $ 3,290 $ 839 $ 6,337 $ 1,681 General and administrative 3,465 595 5,431 1,161 -------- -------- -------- -------- Total stock-based compensation expense $ 6,755 $ 1,434 $ 11,768 $ 2,842 ======== ======== ======== ======== (3) Shares used in computing net loss per share exclude approximately 10.6 million and 10.3 million shares issuable upon exercise of outstanding stock options and warrants and shares subject to repurchase as of June 30, 2006 and 2005, respectively, as their effect would be antidilutive. THERAVANCE, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except per share data) June 30, December 31, 2006 2005 ------------ ------------ (unaudited) (2) Assets Cash, cash equivalents and marketable securities $ 242,441 $ 161,925 Other current assets 5,066 4,893 Marketable securities - non-current 51,045 38,084 Property and equipment, net 13,413 13,180 Other assets 6,932 6,753 ------------ ------------ Total assets $ 318,897 $ 224,835 ============ ============ Liabilities and stockholders equity Current liabilities, net of current portion of deferred revenue (1) $ 32,595 $ 31,179 Deferred revenue (1) 154,112 128,245 Other long-term liabilities 6,583 5,827 Stockholders equity 125,607 59,584 ------------ ------------ Total liabilities and stockholders equity $ 318,897 $ 224,835 ============ ============ (1) Deferred revenue includes the current portion of $21.5 million and $17.0 million as of June 30, 2006 and December 31, 2005, respectively. The net increase in total deferred revenue is a result of additional upfront and milestone payments that were earned under the company's strategic alliance with GSK and its collaboration with Astellas partially offset by the amortization of deferred revenue. (2) The condensed consolidated balance sheet amounts at December 31, 2005 are derived from audited financial statements.
Contact Information: Investors Theravance, Inc. Allison Parker Director, Investor Relations 650-808-4100 aparker@theravance.com Media Theravance, Inc. David Brinkley SVP, Commercial Development 650-808-3784 dbrinkley@theravance.com