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SEC Comment Letter for Innoviva, Inc. (INVA) (CIK 0001080014) (INVA) — Mar 30, 2006

Innoviva, Inc. (INVA) (CIK 0001080014)
Date: March 30, 2006 · CIK: 0001080014 · Accession: 0000000000-06-015242

AI Filing Summary & Sentiment

File numbers found in text: 000-30319

Date
March 30, 2006
Author
Jim B. Rosenberg
Form
UPLOAD
Company
Innoviva, Inc. (INVA) (CIK 0001080014)

Letter

Via Facsimile and U.S. Mail Mail Stop 6010 March 30, 2006 Mr. Rick E. Winningham Chief Executive Officer Theravance, Inc. 901 Gateway Boulevard South San Francisco, California 94080

Re: Theravance, Inc. Form 10-K for the Fiscal Year Ended December 31, 2005 Filed March 8, 2006 File No. 000-30319

Dear Mr. Winningham:

We have reviewed your filing and have the following comments. We have limited our review to only your financial stat ements and related disclosures and do not intend to expand our review to other portions of your docum ent. In our comments, we ask you to provide us with information so we may better understa nd your disclosure. Please be as detailed as nece ssary in your explanation. Afte r reviewing this information, we may raise additional comments.

Please understand that the purpose of our re view process is to assist you in your compliance with the applicable disclosure requirements and to enhance the overall disclosure in your filings. We look forward to working with you in these respects. We welcome any questions you may have about our comments or on any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter.

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations, page 35

Collaboration Arrangements, page 36

2004 Strategic Alliance with GSK, page 37

1. In light of the redemption rights held by GSK, please tell us how classification of the common stock subject to those rights within permanent equity complies with GAAP particularly EITF D-98.

Mr. Rick E. W inningha m Theravance, Inc. March 30, 2006 Page 2

Results of Operations, page 39

Research & Developm ent, page 39

2. We have the following comm ents about your current disclosure about your research and developm ent expenses:

a. It appears that you no longe r disclose that you do not track all of these expenses on a project basis, as you had on page 29 of Am endm ent #7 to Form S-1 filed on October 1, 2004. As such, please provide us, in disclosu re-type for mat, the cos t incurred during each period presented an d to date for each of your m ajor projects , to the extent you are able. To the extent that y ou are unab le, pleas e pro vide us, in disclosure-type for mat,: (i) a statem ent to th at effect; (ii) an explanation of why m anagement does not m aintain and evaluate resear ch and developm ent costs by m ajor project; and, (iii) other quantitative or qualita tive disclosu re that ind icates the am ount of the com pany’s resources being used on each m ajor project.

b. It appears that you no lo nger disclose that you are unable to estim ate the length of tim e or the costs that will be required to com plete the developm ent of your product candidates, as you had on page 27 of Amendm ent #7 to Form S-1 filed on October 1, 2004. In addition, on page 16 of this filing, you disclose wh en you expect to com plete the first of your Phase 3 clinical studies for te lavancin, which would appears to be one of your candidates. As such, pl ease provide us, in disclosure-type format, the following inf ormation for each m ajor project or po int us to the specific locations within your document where each bullet is addressed:

• The nature, tim ing and estim ated costs of the efforts necessary to complete the proje ct; • The antic ipated com pletion dates ; and finally • The period in which m aterial ne t cash inflows from significant projects are expected to commence.

In so doing, indicate the am ount or ra nge of estimated costs and tim ing to complete the phase in process and each future phase. To the extent that information is not es timable, state th ose facts and circum stances indicating the uncertainties that preclude you f rom making a reasonable estim ate.

Mr. Rick E. W inningha m Theravance, Inc. March 30, 2006 Page 3

Item 8. Financial S tatem ents and Supplem entary Data, page 47

Notes to Consolidated F inancial Statem ents, page 52

3. Collaboration Agreem ents, page 60

3. Please tell u s the ex tent to which thes e agreem ents are with in the scope of SFAS 68, by referencing paragraph 3. To the ex tent they are, please provide us, in disclosure-type for mat, the am ount of costs incurred under those agreements during each period presented, as required by paragraph 14(b).

* * * *

Please respond to these comm ents within 10 business days or tell us when you will prov ide us with a res ponse. Please furnish a letter that k eys your resp onses to our comments and provide the requested inform ation. Detailed letters gr eatly facilitate our review. Please file your letter on E DGAR under the form type label CORRESP.

We urge all persons who are responsible for the accuracy and adequacy of the disclosu re in the f iling to be cer tain that the filing include all in formation required under the Securities Exchange Act of 1934 and th at they have provided all inform ation investors require for an inform ed invest ment decision. Since the com pany and its manage ment are in possession of all f acts re lating to a com pany’s disclosure, they are responsib le for the accu racy and adequacy of the disclosu res they have m ade.

In connection with responding to our co mments, please provide, in your letter, a statem ent fr om the company ackno wledging th at:

• the com pany is respon sible for the adequacy and accuracy of the dis closure in the filings; • staff comm ents or chang es to dis closure in response to staff comm ents do not foreclose the Comm ission from taking any actio n with respe ct to the f iling; and • the com pany m ay not assert staff comme nts as a defense in any proceeding initiated by the Comm ission or any person under the federal secu rities law s of the United States.

In addition, please be advise d that the Division of Enfo rcement has access to all inform ation you provide to the staff of the Divi sion of Corporation Fi nance in our review of your filin g or in respo nse to our comm ents on your filing.

Mr. Rick E. W inningha m Theravance, Inc. March 30, 2006 Page 4

You m ay contact Jim Peklenk, Staff Accountant, at (202) 551-3661, or Oscar Young, Senior Staff Accountant, at (202) 551- 3622 if you have quest ions regarding the comments. In this regard, do not hes itate to contact m e, at (202) 551-3679.

Sincerely,
Jim B. Rosenberg
Senior Assistant Chief
Accountant

Show Raw Text
Via Facsimile and U.S. Mail
Mail Stop 6010

                                                                                                March 30, 2006

Mr. Rick E. Winningham
Chief Executive Officer
Theravance, Inc.
901 Gateway Boulevard
South San Francisco, California 94080

Re: Theravance, Inc.
 Form 10-K for the Fiscal Year Ended December 31, 2005
 Filed March 8, 2006
 File No. 000-30319

Dear Mr. Winningham:

We have reviewed your filing and have the following comments.  We have
limited our review to only your financial stat ements and related disclosures and do not
intend to expand our review to  other portions of your docum ent.  In our comments, we
ask you to provide us with information so we may better understa nd your disclosure.
Please be as detailed as nece ssary in your explanation.  Afte r reviewing this information,
we may raise additional comments.

 Please understand that the purpose of our re view process is to assist you in your
compliance with the applicable disclosure requirements and to enhance the overall
disclosure in your filings.  We look forward to working with you in these respects.  We
welcome any questions you may have about our comments or on any other aspect of our review.  Feel free to call us at the telephone numbers listed at the end of this letter.

Item 7.  Management’s Discussion and Analysis of Financial Condition and Results of
Operations, page 35

Collaboration Arrangements, page 36

2004 Strategic Alliance with GSK, page 37

1. In light of the redemption rights held by GSK, please tell us how classification of
the common stock subject to those rights within permanent equity complies with
GAAP particularly EITF D-98.

Mr. Rick E. W inningha m
Theravance,  Inc.
March 30, 2006
Page 2

Results of Operations, page 39

Research & Developm ent, page 39

2. We have the following comm ents about  your current disclosure about your
research and developm ent expenses:

a. It appears that you no longe r disclose that you do not track all of these
expenses on a project basis, as you had on page 29 of Am endm ent #7 to
Form  S-1 filed on October 1, 2004.  As  such, please provide us, in
disclosu re-type for mat, the cos t incurred during each period presented an d
to date for each of your m ajor projects , to the extent you are able.  To the
extent that y ou are unab le, pleas e pro vide us, in disclosure-type for mat,:
(i) a statem ent to th at effect; (ii) an explanation of why m anagement does
not m aintain and evaluate resear ch and developm ent costs by m ajor
project; and, (iii) other quantitative or  qualita tive disclosu re that ind icates
the am ount of the com pany’s resources  being used on each m ajor project.

b. It appears that you no lo nger disclose that you are unable to estim ate the
length of tim e or the costs that will be required to com plete the
developm ent of your product candidates, as you had on page 27 of
Amendm ent #7 to Form  S-1 filed on October 1, 2004.  In addition, on
page 16 of this filing, you disclose wh en you expect to com plete the first
of your Phase 3 clinical studies for te lavancin, which would appears to be
one of your candidates.  As such, pl ease provide us, in disclosure-type
format, the following inf ormation for each m ajor project or po int us to the
specific locations within  your document where each bullet is addressed:

• The nature, tim ing and estim ated costs of the efforts necessary to
complete the proje ct;
• The antic ipated com pletion dates ; and finally
• The period in which m aterial ne t cash inflows from  significant
projects are expected to commence.

In so doing, indicate the am ount or ra nge of estimated costs and tim ing to
complete the phase in process and each future phase.  To the extent that
information is not es timable, state th ose facts and circum stances indicating
the uncertainties that preclude you f rom making a reasonable estim ate.

Mr. Rick E. W inningha m
Theravance,  Inc.
March 30, 2006
Page 3

Item 8.  Financial S tatem ents and Supplem entary Data, page 47

Notes to Consolidated F inancial Statem ents, page 52

3.  Collaboration Agreem ents, page 60

3. Please tell u s the ex tent to which thes e agreem ents are with in the scope of SFAS
68, by referencing paragraph 3.  To the ex tent they are, please provide us, in
disclosure-type for mat, the am ount of costs incurred under those agreements
during each period presented, as  required by paragraph 14(b).

*    *    *    *

Please respond to these comm ents within  10 business days or tell us when you
will prov ide us with a res ponse.   Please furnish a letter that k eys your resp onses to our
comments and provide the requested inform ation.  Detailed letters gr eatly facilitate our
review.  Please file your letter on E DGAR under the form  type label CORRESP.

 We urge all persons who are responsible for the accuracy and adequacy of the
disclosu re in the f iling to  be cer tain that the filing include all in formation required under
the Securities Exchange Act of 1934 and th at they have provided all inform ation
investors require for an inform ed invest ment decision.  Since the com pany and its
manage ment are in possession of all f acts re lating to a com pany’s disclosure, they are
responsib le for the accu racy and adequacy of the disclosu res they have m ade.

 In connection with responding to our co mments, please provide, in your letter, a
statem ent fr om the company ackno wledging th at:

• the com pany is respon sible for the adequacy  and accuracy of the dis closure in the
filings;
• staff comm ents or chang es to dis closure in response to staff comm ents do not
foreclose the Comm ission from  taking any actio n with respe ct to the f iling; and
• the com pany m ay not assert staff comme nts as a defense in any proceeding
initiated by the Comm ission or any person under the federal secu rities law s of the
United States.

In addition, please be advise d that the Division of Enfo rcement has access to all
inform ation you provide to the staff of the Divi sion of Corporation Fi nance in our review
of your filin g or in respo nse to our comm ents on your filing.

Mr. Rick E. W inningha m
Theravance,  Inc.
March 30, 2006
Page 4

You m ay contact Jim  Peklenk, Staff Accountant, at  (202) 551-3661, or Oscar
Young, Senior Staff Accountant, at (202) 551- 3622 if you have quest ions regarding the
comments.  In this regard, do not hes itate to contact m e, at (202) 551-3679.

Sincerely,

Jim B. Rosenberg
Senior Assistant Chief
Accountant