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Vanda Pharmaceuticals Inc.
Response Received
1 company response(s)
High - file number match
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Vanda Pharmaceuticals Inc.
Response Received
1 company response(s)
High - file number match
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Vanda Pharmaceuticals Inc.
Response Received
1 company response(s)
High - file number match
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Vanda Pharmaceuticals Inc.
Awaiting Response
0 company response(s)
High
Vanda Pharmaceuticals Inc.
Response Received
3 company response(s)
High - file number match
SEC wrote to company
2014-12-30
Vanda Pharmaceuticals Inc.
Filing - SEC Comment Letter to Vanda Pharmaceuticals Inc.
UPLOAD · 2014-12-30
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Company responded
2015-01-08
Vanda Pharmaceuticals Inc.
References: December 30, 2014
Filing - Correspondence from Vanda Pharmaceuticals Inc.
CORRESP · 2015-01-08
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Company responded
2015-01-30
Vanda Pharmaceuticals Inc.
Filing - Correspondence from Vanda Pharmaceuticals Inc.
CORRESP · 2015-01-30
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Company responded
2015-02-27
Vanda Pharmaceuticals Inc.
References: January 30, 2015
Filing - Correspondence from Vanda Pharmaceuticals Inc.
CORRESP · 2015-02-27
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Vanda Pharmaceuticals Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2009-04-14
Vanda Pharmaceuticals Inc.
Filing - SEC Comment Letter to Vanda Pharmaceuticals Inc.
UPLOAD · 2009-04-14
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Vanda Pharmaceuticals Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2006-01-27
Vanda Pharmaceuticals Inc.
Filing - SEC Comment Letter to Vanda Pharmaceuticals Inc.
UPLOAD · 2006-01-27
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Company responded
2006-04-07
Vanda Pharmaceuticals Inc.
Filing - Correspondence from Vanda Pharmaceuticals Inc.
CORRESP · 2006-04-07
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Vanda Pharmaceuticals Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2006-03-28
Vanda Pharmaceuticals Inc.
Filing - SEC Comment Letter to Vanda Pharmaceuticals Inc.
UPLOAD · 2006-03-28
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Company responded
2006-04-07
Vanda Pharmaceuticals Inc.
Filing - Correspondence from Vanda Pharmaceuticals Inc.
CORRESP · 2006-04-07
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Vanda Pharmaceuticals Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2006-03-28
Vanda Pharmaceuticals Inc.
Filing - SEC Comment Letter to Vanda Pharmaceuticals Inc.
UPLOAD · 2006-03-28
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-04-24 | Company Response | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| 2026-02-18 | SEC Comment Letter | Vanda Pharmaceuticals Inc. | DE | 333-293404 | Read Filing View |
| 2023-05-03 | Company Response | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| 2023-02-16 | SEC Comment Letter | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| 2015-07-17 | Company Response | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| 2015-07-16 | SEC Comment Letter | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| 2015-03-06 | SEC Comment Letter | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| 2015-02-27 | Company Response | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| 2015-01-30 | Company Response | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| 2015-01-08 | Company Response | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| 2014-12-30 | SEC Comment Letter | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| 2009-04-14 | SEC Comment Letter | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| 2006-04-07 | Company Response | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| 2006-04-07 | Company Response | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| 2006-03-28 | SEC Comment Letter | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| 2006-03-28 | SEC Comment Letter | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| 2006-01-27 | SEC Comment Letter | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-02-18 | SEC Comment Letter | Vanda Pharmaceuticals Inc. | DE | 333-293404 | Read Filing View |
| 2023-02-16 | SEC Comment Letter | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| 2015-07-16 | SEC Comment Letter | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| 2015-03-06 | SEC Comment Letter | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| 2014-12-30 | SEC Comment Letter | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| 2009-04-14 | SEC Comment Letter | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| 2006-03-28 | SEC Comment Letter | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| 2006-03-28 | SEC Comment Letter | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| 2006-01-27 | SEC Comment Letter | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-04-24 | Company Response | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| 2023-05-03 | Company Response | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| 2015-07-17 | Company Response | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| 2015-02-27 | Company Response | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| 2015-01-30 | Company Response | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| 2015-01-08 | Company Response | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| 2006-04-07 | Company Response | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
| 2006-04-07 | Company Response | Vanda Pharmaceuticals Inc. | DE | N/A | Read Filing View |
2026-04-24 - CORRESP - Vanda Pharmaceuticals Inc.
CORRESP 1 filename1.htm CORRESP 2200 Pennsylvania Avenue NW Suite 300E Washington, DC 20037 April 24, 2026 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Tyler Howes, Office of Life Sciences Re: Vanda Pharmaceuticals Inc. Registration Statement on Form S-3 Filed February 12, 2026 File No. 333-293404 REQUEST FOR ACCELERATION OF EFFECTIVENESS Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Vanda Pharmaceuticals Inc. (the “Company”) hereby requests that the Securities and Exchange Commission take appropriate action to make the above-referenced Registration Statement on Form S-3 effective at 9:00 a.m. Eastern Time on May 5, 2026, the date on which the Company’s currently effective Registration Statement on Form S-3 is set to expire, or as soon thereafter as practicable. The Company hereby authorizes Gregg Griner, who is an attorney with the Company’s outside legal counsel, Orrick, Herrington & Sutcliffe LLP, to orally modify or withdraw this request for acceleration. The Company requests that it be notified of such effectiveness by a telephone call to Mr. Griner at (617) 880-2212. Very truly yours, Vanda Pharmaceuticals Inc. By: /s/ Kevin Moran Kevin Moran Senior Vice President, Chief Financial Officer, Treasurer and Secretary cc: Gregg Griner, Orrick, Herrington & Sutcliffe LLP
2026-02-18 - UPLOAD - Vanda Pharmaceuticals Inc. File: 333-293404
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> February 18, 2026 Mihael Polymeropoulos Chief Executive Officer Vanda Pharmaceuticals Inc. 2200 Pennsylvania Avenue NW Suite 300E Washington, DC 20037 Re: Vanda Pharmaceuticals Inc. Registration Statement on Form S-3 Filed February 12, 2026 File No. 333-293404 Dear Mihael Polymeropoulos: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Tyler Howes at 202-551-3370 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Gregg A. Griner, Esq. </TEXT> </DOCUMENT>
2023-05-03 - CORRESP - Vanda Pharmaceuticals Inc.
CORRESP 1 filename1.htm CORRESP Vanda Pharmaceuticals Inc. 2200 Pennsylvania Avenue NW Suite 300E Washington, DC 20037 May 3, 2023 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F. Street N.E. Washington, D.C. 20549 Attn: Cynthia Polynice Re: Vanda Pharmaceuticals Inc. Registration Statement on Form S-3 (File No. 333-269654) Dear Ms. Polynice: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Vanda Pharmaceuticals Inc. (the “Company”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to make the above-referenced Registration Statement on Form S-3 effective at 4:30 p.m. Eastern Time on Friday, May 5, 2023 or as soon thereafter as practicable. The Company hereby acknowledges that: • should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. The Company hereby authorizes Gregg Griner of Orrick, Herrington & Sutcliffe LLP, counsel to the Company, to orally modify or withdraw this request for acceleration. Please provide a copy of the Commission’s order declaring the Registration Statement effective to Gregg Griner at Orrick, Herrington & Sutcliffe LLP, 222 Berkeley Street, Suite 2000, Boston, MA 02216. If possible, please also send such order by email to the attention of Gregg Griner at ggriner@orrick.com. Thank you for your attention on this matter. Very truly yours, Vanda Pharmaceuticals Inc. By: /s/ Timothy Williams Timothy Williams Senior Vice President, General Counsel and Secretary cc: Gregg Griner, Orrick, Herrington & Sutcliffe LLP Albert Vanderlaan, Orrick, Herrington & Sutcliffe LLP
2023-02-16 - UPLOAD - Vanda Pharmaceuticals Inc.
United States securities and exchange commission logo
February 16, 2023
Dr. Mihael Polymeropoulos
President and Chief Executive Officer
Vanda Pharmaceuticals Inc.
2200 Pennsylvania Avenue NW, Suite 300E
Washington, DC 20037
Re:Vanda Pharmaceuticals Inc.
Registration Statement on Form S-3
Filed February 9, 2023
File No. 333-269654
Dear Dr. Mihael Polymeropoulos:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Cindy Polynice at 202-551-8707 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Gregg A. Griner, Esq.
2015-07-17 - CORRESP - Vanda Pharmaceuticals Inc.
CORRESP 1 filename1.htm CORRESP Vanda Pharmaceuticals Inc. 2200 Pennsylvania Avenue NW Suite 300E Washington, DC 20037 July 17, 2015 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F. Street N.E. Washington, D.C. 20549 Attn: Alla Berenshteyna Re: Vanda Pharmaceuticals Inc. Registration Statement on Form S-3 (File No. 333-205513) Dear Ms. Berenshteyna: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Vanda Pharmaceuticals Inc. (the “Company”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to make the above-referenced Registration Statement on Form S-3 effective at 4:30 p.m. Eastern Time on Tuesday, July 21, 2015 or as soon thereafter as practicable. The Company hereby acknowledges that: • should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. The Company hereby authorizes Gregg Griner of Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP, counsel to the Company, to orally modify or withdraw this request for acceleration. Please provide a copy of the Commission’s order declaring the Registration Statement effective to Gregg Griner at Gunderson Dettmer, One Marina Park Drive, Suite 900, Boston, MA 02210. If possible, please also send such order by email to the attention of Gregg Griner at ggriner@gunder.com. Thank you for your attention on this matter. Very truly yours, Vanda Pharmaceuticals Inc. By: /s/ James P. Kelly James P. Kelly Chief Financial Officer cc: Gregg Griner, Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP Albert Vanderlaan, Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP
2015-07-16 - UPLOAD - Vanda Pharmaceuticals Inc.
July 16 , 2015 Via E -mail Mihael H. Polymeropoulos, M.D. President and Chief Executive Officer Vanda Pharmaceuticals, Inc. 2200 Pennsylvania Avenue NW, Suite 300E Washington, DC 20037 Re: Vanda Pharmaceuticals, Inc. Registration Statement on Form S -3 Filed July 6 , 2015 File No. 333-205513 Dear Dr. Polymeropoulos : This is to advise you that we have not reviewed and will not review your registration statement . We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In the event you request acceleration of the effective date of the pending regist ration statement , please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action wit h respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in th e filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 4 61 regarding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation Mihael H. Polymeropoulos Vanda Pharmaceuticals , Inc. July 16 , 2015 Page 2 of the fact that those requesting acceleration are aware of their respective responsibilities u nder the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the registered securities . Please contact Alla Berenshteyn at (202) 551 -4325 or me at (202) 551 -3715 with any questions. Sincerely, /s/ Bryan J. Pitko for Jeffrey P. Riedler Assistant Director cc: Via E -mail Albert W. Vanderlaan, Esq. Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP
2015-03-06 - UPLOAD - Vanda Pharmaceuticals Inc.
March 6, 2015
Via E -mail
James P. Kelly
Senior Vice President, Chief Financial Officer, Secretary and Treasurer
Vanda Pharmaceuticals Inc.
2200 Pennsylvania Avenue, N.W., Suite 300 E
Washington, D.C. 20037
Re: Vanda Pharmaceuticals Inc .
Form 10 -K for the Fiscal Year Ended December 31, 2013
Filed February 25 , 2014
File No. 001-34186
Dear Mr. Kelly :
We have completed our review of your filings. We remind you that our comments or
changes to disclosure in response to our comments do not foreclose the Commission from taking
any action with respect to the company or the filing and the company may not assert staff
comments as a defense in any proceeding initiated by the Commission or any person under the
federal securities laws of the United States. We urge all persons who are responsible for the
accuracy and adequacy of the disclosure in the filing to be certain that the filing include s the
information the Securities Exchange Act of 1934 and all applicable rules require.
Sincerely,
/s/ Joel Parker
Joel Parker
Accounting Branch Chief
2015-02-27 - CORRESP - Vanda Pharmaceuticals Inc.
CORRESP 1 filename1.htm Correspondence VANDA PHARMACEUTICALS INC. 2200 Pennsylvania Avenue NW, Suite 300E Washington, DC 20037 February 27, 2015 VIA EDGAR AND OVERNIGHT COURIER Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Attention: Jim Rosenberg Joel Parker Christine Torney Re: Vanda Pharmaceuticals Inc. Form 10-K for the Fiscal Year Ended December 31, 2013 Filed February 25, 2014 Form 10-Q for the Quarterly Period Ended September 30, 2014 Filed October 27, 2014 File No. 001-34186 Dear Mr. Rosenberg: Vanda Pharmaceuticals Inc. (the “Company”) is providing this letter in response to a comment from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) received by the Company relating to the Company’s Form 10-K for the fiscal year ended December 31, 2013 and Form 10-Q for the quarterly period ended September 30, 2014. The Company originally addressed the comment in its comment response letter dated January 30, 2015. During a telephone conference with the Staff on February 20, 2015, the Staff provided additional clarification regarding its comment. For your convenience, we have repeated the Staff’s original written comment in italicized print. This letter contains the Company’s complete revised response to the Staff’s comment, as clarified during the telephone conference. The response below is based solely on the inquiry that the Company has conducted and materials it has reviewed as of February 27, 2015 in response to the Staff’s comment. Form 10-Q for the Quarterly Period Ended September 30, 2014 Management’s Discussion and Analysis of Financial Condition and Results of Operations Results of Operations, page 26 2. You disclose on pages 27 and 28 that you expensed the cost of HETLIOZ manufactured prior to FDA approval and that you expect that your cost of goods sold as a percentage of sales will increase in future periods as product manufactured prior to FDA approval is consumed. Please provide us proposed disclosure to be included in future periodic reports that includes the following: • the estimated selling price or range of reduced-cost inventory you have at the latest balance sheet date presented and an indication as to the time period you expect to sell this inventory; and • the estimated cost of goods sold or range, if determinable, as a percentage of sales that you expect to incur after the reduced-cost inventory has been consumed. Securities and Exchange Commission February 27, 2015 Page 2 Revised response to Comment 2: Inventory manufactured and expensed as research and development expense prior to FDA approval consisted solely of raw materials and work-in-process inventory. As discussed in our periodic filings, we tracked the quantities of individual product lots manufactured. We did not track pre-FDA approval manufacturing costs in a manner that enabled identification of amounts that could be subsequently attributed to the carrying value of commercial inventory and therefore the manufacturing cost of inventory produced prior to FDA approval is not reasonably determinable. Upon approval of HETLIOZ®, the Company began to track commercial inventory-related costs separately, which forms the basis of the carrying value of capitalized commercial inventory. In response to the Staff’s comments above, the Company undertakes to include in future periodic filings substantially the following disclosures in the Management’s Discussion and Analysis of Financial Condition and Results of Operations section entitled “Cost of goods sold”: “HETLIOZ® inventory manufactured prior to FDA approval consisted of raw materials and work-in-process inventory, which was expensed as research and development costs as incurred and was combined with other research and development expenses. While we tracked the quantities of individual product lots, we did not track pre-FDA approval manufacturing costs and therefore the manufacturing cost of HETLIOZ® raw materials and work-in-process inventory produced prior to FDA approval is not reasonably determinable. However, based on our expectations for future manufacturing costs to produce HETLIOZ® inventory, we estimate that approximately $1.2 million of commercial HETLIOZ® inventory was expensed prior to FDA approval. We began capitalizing HETLIOZ® manufacturing costs as inventory following the receipt of marketing approval from the FDA on January 31, 2014. As of [ ], we had approximately $[ ] million, $[ ] million and $[ ] million of reduced-cost finished goods, work-in-process inventory and raw materials inventory, respectively, on hand. The aggregate selling price of reduced-cost finished goods inventory on hand may be affected by a number of factors including, but not limited to, market demand, future pricing of the product, competition and reimbursement by government and other payers. At this time we cannot reasonably estimate the timing and rate of consumption of reduced-cost raw materials and work-in-progress inventory, or the timing of sales of finished goods manufactured with this inventory. We expect our cost of goods sold to increase in the future as this inventory is sold, which will have a negative impact on gross margin. The time period over which reduced-cost finished goods inventory is Securities and Exchange Commission February 27, 2015 Page 3 consumed will depend on a number of factors, including the amount of future HETLIOZ® sales, the ultimate use of this inventory in either commercial sales, clinical development or other research activities, and the ability to utilize inventory prior to its expiration date. Cost of goods sold as a percentage of revenue for the expected sales of inventory capitalized after FDA approval will depend upon our cost to manufacture inventory at normalized production levels with our third party manufacturers. However, we expect that, in the future, total HETLIOZ® manufacturing cost included in cost of goods sold will be less than 2% of our net HETLIOZ® product revenue.” * * * * In connection with our response to the Staff’s comment, the Company acknowledges that: • it is responsible for the adequacy and accuracy of the disclosure in the filing; • Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the filings; and • it may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. * * * * Please do not hesitate to contact me at (202) 734-3428 if you have any questions or would like additional information regarding this matter. Very truly yours, /s/ James P. Kelly James P. Kelly Senior Vice President, Chief Financial Officer, Secretary and Treasurer
2015-01-30 - CORRESP - Vanda Pharmaceuticals Inc.
CORRESP 1 filename1.htm CORRESP January 30, 2015 VIA EDGAR AND OVERNIGHT COURIER Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Attention: Jim Rosenberg Joel Parker Christine Torney Re: Vanda Pharmaceuticals Inc. Form 10-K for the Fiscal Year Ended December 31, 2013 Filed February 25, 2014 Form 10-Q for the Quarterly Period Ended September 30, 2014 Filed October 27, 2014 File No. 001-34186 Dear Mr. Rosenberg: Vanda Pharmaceuticals Inc. (the “Company”, “we”, “our”) is providing this letter in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) received by the Company relating to the Company’s Form 10-K for the fiscal year ended December 31, 2013 (the “2013 10-K”) and Form 10-Q for the quarterly period ended September 30, 2014 (the (“2014 Q3”). For your convenience, we have repeated your comments in italicized print. The Company’s responses are provided below for each comment. The responses below are based solely on the inquiry that the Company has conducted and materials it has reviewed as of January 30, 2015 in response to the Staff’s comments. Form 10-Q for the Quarterly Period Ended September 30, 2014 Notes to Condensed Consolidated Financial Statements (unaudited) 2. Summary of significant Accounting Policies Net Product Revenue, page 9 1. In light of your recent launch of HETLIOZ, please provide us an analysis of each condition in ASC 605-15-25-1 that supports that you met each condition. Also, provide us an analysis of each of factor in ASC 605-15-25-3 to demonstrate you had the ability to make a reasonable estimate of future returns. Further, provide us an analysis supporting that you were able to reasonably estimate provisions for rebates, chargebacks, Medicare Part D Coverage Gap, and co-pay assistance. Response to Comment 1: In consideration of the guidance provided in ASC 605-15-25-1and ASC 605-15-25-3, the Company advises the Staff that although HETLIOZ® is new to the market, we can reasonably estimate expected returns, rebates, chargebacks, Medicare Part D Coverage Gap and co-pay assistance for each reporting period, including the period in which HETLIOZ® was launched, for several reasons. 1. We have a carefully controlled distribution model. We sell only to a limited number of specialty pharmacies (“SPs”) and one Managed Care Organization. SPs sell product directly to patients, who do not have a right of return. 2. The Company’s SPs are contractually required to provide the Company information on the amount of product dispensed to patients and held in their inventory. As a result, the Company knows how much product was sold through the distribution channel and how much the SPs are holding at the end of the reporting period. In addition, based on data received from the SPs shortly after a period end, we are able to determine whether SP inventory on hand as of the end of that period has been sold through the distribution channel. Therefore, the Company knows how much product may be subject to return, if any, at the end of a period. 3. SPs and patients can usually obtain product within one business day (i.e. just-in-time basis) thus limiting the need for large quantities of inventory in the distribution channel. 4. HETLIOZ® is prescribed for the treatment of a Non-24-Hour Sleep-Wake Disorder (“Non-24”). This is a rare, circadian rhythm disorder for which no other FDA approved treatment exists. At this time, we are unaware of any other treatments in development for Non-24. 5. SPs may only return product damaged in-transit, six months prior to and six months after the expiration date. To date, all product shipped has had at least 12 months of shelf life remaining. SPs are required to inspect and accept product upon delivery and report non-conformity with 10 business days of delivery. Therefore, the Company has visibility into any product damaged in-transit to the SPs. In addition, SPs track product at their facilities by individual unit manufacturing lot number. The Company compares this data with its manufacturing data to evaluate if there is a risk of expiration. 6. By reviewing data collected by HETLIOZSolutionsTM, our patient support program, the Company knows how many prescriptions have been submitted by physicians, and of those, how many are unfulfilled at the end of a period. This information is compared to the quantity on hand at the SPs at the end of the reporting period. Currently, the number of unfulfilled prescriptions and refill expectations exceed the quantity held by SPs. This excess demand over SP supply creates a reasonable expectation that period- end inventory will be sold in advance of its expiration. 7. Given HETLIOZ®’s price to the SPs, any inventory build-up would require significant use of their working capital. With no incentive to stockpile inventory, SPs would be unlikely to finance inventory in excess of what is expected to be dispensed. The Company expects the amount of inventory on hand at any particular SP to be below three weeks at any given time. 8. Since launching HETLIOZ® in April 2014, our historical product returns for HETLIOZ® have been zero. Based on historical peer analysis of other similarly priced, small molecule orphan drugs, the likelihood of product returns is minimal. 9. Since launching HETLIOZ® in April 2014, we have not recorded any bad debt expense nor have we recorded any allowance for doubtful accounts. The Company has been selective when choosing the SPs to join the HETLIOZ® distribution network to ensure quality of execution and to limit credit risk. 10. HETLIOZSolutionsTM maintains data about each patient and prescription. Based on this information, we know which insurers or government payors cover those patients. Since the SPs hold very little inventory (to date under 3 weeks), only a small percent of sales in a period are subject to estimates of the eventual payor as of the end of the period. During the weeks after the period end, this payor data becomes known in time for management to include in the financial results if materially different than estimates. 11. At the time of the HETLIOZ® launch in 2014, the information and circumstances noted above were in place and therefore enabled the Company to reasonably estimate expected returns, rebates, chargebacks, Medicare Part D Coverage Gap and co-pay assistance In accordance with ASC 605-15-25-1, the Company does not recognize revenue until all of the following criteria are met for product sales where a right of return exists. Based on the discussion above, we believe that the criteria outlined within ASC 605-15-25-1 are satisfied upon delivery of HETLIOZ® to the SPs. • The seller’s price to the buyer is substantially fixed or determinable at the date of sale. The price is fixed or determinable at the time of delivery to the SPs. At that point, any returns or other sales deductions can be reasonably estimated. • The buyer has paid the seller, or the buyer is obligated to pay the seller and the obligation is not contingent on resale of the product. The SPs are contractually obligated to pay the Company upon receipt of HETLIOZ®, and payment to the Company is not contingent upon the SP shipping the product to a patient. • The buyer’s obligation to the seller would not be changed in the event of theft or physical destruction or damage of the product. Product is shipped to the SPs F.O.B. destination. Title and risk of loss pass upon delivery to the SPs. SPs are required to inspect and accept product upon delivery and report non-conformity with 10 business days of delivery. • The buyer acquiring the product for resale has economic substance apart from that provided by the seller. The SPs derive an economic benefit from sales of HETLIOZ®. • The seller does not have significant obligations for future performance to directly bring about resale of the product by the buyer. The Company does not have any future obligations to the SPs in order to have them resell HETLIOZ®. • The amount of future returns can be reasonably estimated. Consistent with industry practice, the Company offers SPs a limited right of return. Once product has been labeled, the right of return is substantially eliminated with the exception being product returns linked to quality issues (e.g., FDA recall). In addition, product dispensed to patients may not be returned to us. Since launching HETLIOZ® in April 2014, our historical product returns for HETLIOZ® have been zero. The right of return guidance in ASC 605-15-25 indicates that revenue generally may be recognized at the time of sale when the buyer has the right to return a product or receive a refund of consideration paid to the vendor if a reasonable estimate of future returns or refunds can be made pursuant to the provisions of the rights of return. The Company offers SPs a limited right of return. As mentioned above, once product has been labeled, the right of return is substantially eliminated and product dispensed to patients may not be returned. In response to the Staff’s comments above, we individually assessed the four factors discussed in ASC 605-15-25-3, which may impair a company’s ability to estimate returns, below. • The susceptibility of the product to significant external factors. The probability of external factors such as obsolescence is currently low given the time it takes to develop products and the FDA’s long product approval times. The Company is not aware of any relevant, near-term external factors at this time. • Relatively long periods in which a particular product may be returned. There is a relatively small window of opportunity to return HETLIOZ®. SPs may return product six months prior to and six months after the expiration date. To date, all Product shipped has had at least 12 months of shelf life remaining. Any unit dispensed to a patient cannot be returned due to product dating. Once product has been labeled, the right of return is substantially eliminated with the exception being product returns linked to quality issues (e.g., FDA recall). • Absence of historical experience with similar types of sales of similar products. Despite the Company’s limited sales history, the Company believes the factors discussed above provide sufficient evidence to support a reasonable returns reserve at the time product is delivered to the SP (specifically see item 8 above). • Absence of a large volume of relatively homogeneous transactions. While there is a lack of a large volume of homogenous transactions at this point, the Company believes this factor is outweighed by items 1 through 8 discussed above. The Company believes the factors limiting the ability to estimate returns discussed in ASC 605-15-25-3 discussed above do not preclude it from recognizing revenue at the time HETLIOZ® is delivered to the SPs. As of September 30, 2014, the Company considered the need for a returns reserve and determined that no allowance for product returns was necessary based on consideration of items 1 through 8 discussed above and the four factors discussed in ASC 605-15-25-3. Other Estimates In addition to recognizing HETLIOZ® product revenue net of returns, our gross product sales are also net of deductions for rebates, chargebacks, Medicare Part D Coverage Gap, co-pay assistance, service fees and prompt payment discounts. We record deductions for rebates, chargebacks, Medicare Part D Coverage Gap and co-pay assistance as follows: • Rebates: Rebates only apply to sales under government mandated rebate programs (e.g., Medicaid Drug Rebate Program). Based on information related to the current reporting period received from the SPs and HETLIOZSolutionsTM, the Company has visibility into the actual number of prescriptions fulfilled under government rebate programs. For units not yet sold through the distribution channel, the number of prescriptions is estimated by multiplying the number of units on hand at the SPs by the cumulative average government payer mix. For example, the Medicaid rebate liability is calculated by multiplying actual and estimated unit sales by the Unit Rebate Amount as determined in accordance with the rules of the Medicaid Drug Rebate Program. • Chargebacks: The Company calculates and publishes the Federal Supply Schedule (“FSS”) and PHS / 340B price each period as part of its standard government price reporting process. Wholesale Acquisition Cost less the 340B price, or the FSS price, is the resulting chargeback amount per unit. Based on information related to the current reporting period received from the SPs and HETLIOZSolutionsTM, the Company has visibility into the actual units sold to Public Health Service institutions and Federal government entities (e.g., VA, DOD) at the point of purchase. This results in a known chargeback liability at a period end. For units not yet sold through the distribution channel, the number of prescriptions is estimated by multiplying the number of units on hand at the SPs by the cumulative average chargeback payer mix. The liability associated with units not yet sold through the channel is calculated by multiplying estimated unit sales by the chargeback amount. • Medicare Part D Coverage Gap: Based on information received from the SPs and HETLIOZSolutionsTM, the Company has visibility into the actual number of Medicare prescriptions fulfilled. For units not yet sold through the distribution channel, the number of prescriptions is estimated by multiplying the number of units on hand at the SPs by the cumulative average Medicare payer mix. Based on the structure of the standard Part D plan and the price of HETLIOZ®, the Company estimates the liability per patient. The coverage gap liability is calculated by multiplying actual and estimated unit sales by the average liability per patient. Due to the price of HETLIOZ®, a patient will go through the “doughnut hole” with their first prescription and therefore, the Company only needs to estimate a liability for a patient’s first prescription in a given year. The Company refines its estimates to reflect actual data as quarterly invoices from the Centers for Medicare and Medicaid Services are received. • Co-pay Assistance: Information on the amount of co-pay assistance utilization is provided monthly by the Company’s third party administrator. The allowance for co-pay assistance for dispensed product is based on actual sales and is not an estimate. For units not yet sold through the distribution channel at the end of a period, the amount of co-pay assistance is estimated using the percentage of patients receiving co-pay assistance in a given period and the cumulative average assistance received over time. We continuously monitor reserve estimates recorded for product returns and the other estimates discussed above. If material adjustments are necessary, we will discuss the amount and reason for any significant fluctuation in the Management’s Discussion and Analysis of Financial Condition and Results of Operations section of our periodic filings. Management’s Discussion and Analysis of Financial Condition and Results of Operations Results of Operations, page 26 2. You disclose on pages 27 and 28 that you expensed the cost of HETLIOZ manufactured prior to FDA approval and that you expect that your cost of goods sold as a percentage of sales will increase in future periods as product manufactured prior to FDA approval is consumed. Please provide us proposed disclosure to be included in future periodic reports that includes the following: • the estimated selling price or range of reduced-cost inventory you have at the latest balance sheet date presented and an indication as to the time period you expect to sell this inventory; and • the estimated cost of goods sold or range, if determinable, as a percentage of sales that you expect to incur after the reduced-cost
2015-01-08 - CORRESP - Vanda Pharmaceuticals Inc.
CORRESP 1 filename1.htm Correspondence VANDA PHARMACEUTICALS INC. 2200 Pennsylvania Avenue NW, Suite 300E Washington, DC 20037 January 8, 2015 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Attention: Jeffrey Riedler Jim Rosenberg Joel Parker Christine Torney Re: Vanda Pharmaceuticals Inc. (File No. 001-34186) Request for Extension to Comment Letter Response Dear Mr. Riedler: We are in receipt of the comments of the staff of the Securities and Exchange Commission (the “Staff”) regarding the Form 10-K for the fiscal year ended December 31, 2013 and Form 10-Q for the quarterly period ended September 30, 2014 of Vanda Pharmaceuticals Inc. (the “Company”) set forth in your letter dated December 30, 2014 (the “Comment Letter”). As discussed on January 7, 2015 between you and our outside legal counsel, Gregg Griner of Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP, the Company hereby requests an extension of time to respond to the Comment Letter. The Company will endeavor to respond to the comments made by the Staff in the Comment Letter no later than January 30, 2015. If you have any questions regarding the foregoing, please do not hesitate to contact me at (202) 734-3428. Sincerely, /s/ James P. Kelly James P. Kelly Senior Vice President, Chief Financial Officer, Secretary and Treasurer cc: Mihael H. Polymeropoulos, M.D., Vanda Pharmaceuticals Inc. Gregg Griner, Esq., Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP
2014-12-30 - UPLOAD - Vanda Pharmaceuticals Inc.
December 30 , 2014 Via E -mail James P. Kelly Senior Vice President, Chief Financial Officer, Secretary and Treasurer Vanda Pharmaceuticals Inc. 2200 Pennsylvania Avenue, N.W., Suite 300 E Washington, D.C. 20037 Re: Vanda Pharmaceuticals Inc . Form 10 -K for the Fiscal Year Ended December 31, 2013 Filed February 25 , 2014 Form 10 -Q for the Quarterly Period Ended September 30, 2014 Filed October 27 , 2014 File No. 001-34186 Dear Mr. Kelly : We have limited our review of your filings to your financial statements and related disclosures and do not intend to expand our review to other portions of your document s. In our comment s, we ask you to provide us with information so we may better understand your disclosure. Please respond to this letter within 10 business days by providing the requested information or by advising us when you will provide the requested response. If you do not believe a comment applies to your facts and circ umstances, please tell us why in your response. Please furnish us a letter on EDGAR under the form type label CORRESP that keys your response s to our comment s. After reviewing the information provided, we may raise additional comments and/or request that you amend your filings . Form 10 -Q for the Quarterly Period E nded September 30, 2014 Notes to Condensed Consolidated Financial Stat ements (unaudited) 2. Summary of Significant Accounting Policies Net Product Revenue, page 9 1. In light of your recent launch of HETLIOZ, please provide us an analysis of each condition in ASC 605 -15-25-1 that supports that you met each condition . Also, provide us an analysis of each of factor in ASC 605 -15-25-3 to demonstrate you had the ability to make a reasonable estimate of future returns. Further, provide us an analysis supporting that you Jame s P. Kelly Vanda Pharmaceuticals Inc . December 30 , 2014 Page 2 were able to reasonably estimate provisions for re bates, chargebacks, Medicare Part D Coverage Gap, and co -pay assistance. Management’s Discussion and Analysis of Financial Condition and Results of Operations Results of Operations, page 26 2. You disclose on page s 27 and 28 that you expensed the cost o f HETLIOZ manufactured prior to FDA approval and that you expect that your cost of goods sold as a percentage of sales will increase in future periods as product manufactured prior to FDA approval is consumed. Please provide us proposed disclosure to be i ncluded in future periodic reports that includes the following: the estimated selling price or range of reduced -cost inventory you have at the latest balance sheet date presented and an indication as to the time period you expect to sell this inventory; an d the estimated cost of goods sold or range, if determinable, as a percentage of sales that you expect to incur after the reduced -cost inventory has been consumed. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filings to be certain that the filings include s the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In responding to our comment s, please provide a written statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filings ; staff comment s or changes to disclosure in response to staff comment s do not foreclose the Commission from taking any action with respect to the filings ; and the company may not assert staff commen ts as a defense in any proceedi ng initia ted by the Commission or any person under the federal securities laws of the United States. You may contact Christine Torney, Senior Staff Accountant, at (202) 551 -3652 or Joel Parker, Accounting Branch Chief , at (202) 551 -3651 if you have any questions regarding the comment s. In this regard, do not hesitate to contact me at (202) 551 -3679. Sincerely, /s/ Jim B. Rosenberg Jim B. Rosenberg Senior Assistant Chief Accountant
2009-04-14 - UPLOAD - Vanda Pharmaceuticals Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
Mail Stop 3561
April 14, 2009 By Facsimile and U.S. Mail
Kevin C. Tang Tang Capital Management, LLC 4401 Eastgate Mall San Diego, CA 92121
RE: Vanda Pharmaceuticals, Inc.
Preliminary Proxy Statement Filed on April 7, 2009 Filed by Tang Capital Partners LP, Tang Capital Management LLC, Kevin C. Tang and Andrew D. Levin, M.D., Ph.D. File No. 1-3486
Dear Mr. Tang:
We have conducted a limited review of the filing listed above and have the following
comments. Where indicated, we think you should revise your document in response to these comments. If you disagree, we will consider your explanation as to why a comment is inapplicable or a revision is unnecessary. Please be as detailed as necessary in your explanation. In some of our comments, we may ask you to provide us with supplemental information so we may better understand your disclosure. After reviewing this information, we may or may not raise additional comments. All defined terms used in this letter have the same meaning as in the proxy statement referenced above. Please understand that the purpose of our review 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 any ot her aspect of our review. Feel free to call
us at the telephone numbers listed at the end of this letter. PREC14A
General
1. Please fill in all blanks in the proxy statement.
2. Please confirm that you will post your proxy materials on a specified, publicly-accessible
Internet Web site (other than the Commission’s EDGAR Web site) and provide record holders with a notice informing them that the materials are available and explaining how to access those materials. Refer to Release 34-56135 available at http://www.sec.gov/rules/final/2007/34-56135.pdf
.
Kevin C. Tang
Tang Capital Management, LLC April 14, 2009 Page 2 Background and Reasons for The Solicitation, page 3
3. The background description of the contacts between you and Vanda leading up to this
solicitation is material information with respect to this solicitation. Therefore, please expand your disclosure concerning your discussions with the company and its board with regards to the strategic direction of the company. For example, please specify the approximate dates of your contact with the company and describe the form of the communication(s) (e.g., letter, e-mail, telephone, in person, etc.). If you attempted to contact the Company and did not receive a response, or vice versa, so indicate. In addition, describe the specifics of any discussions between the parties, providing sufficient background as necessary to make the context clear as necessary.
Proposal 1 – Election of Directors, page 7
4. Please explain in sufficient detail why you are seeking Vanda shareholders to vote for
your nominees. In particular, why do you wish the Company to cease operations and distribute its assets to the shareholders? What other actions will your nominees advocate for if they cannot persuade the majority of the directors to support liquidation?
5. We note your disclosure that you reserve the right to nominate additional persons. Please
revise to address whether any advance notice provisions affect your ability to designate other nominees.
6. Pursuant to Item 5 of Schedule 14A, you are required to describe the interests of the
participants (both direct and indirect) in this solicitation. We note that you (Kevin Tang) serve as a director of two other pharmaceutical companies. Do these companies compete or operate in the same segments as the Company? How will you handle any potential conflicts of interest? (or if you believe no su ch conflicts exist, explain why not).
Proposal 2 – Stockholder Resolution, page 9
7. Clearly disclose in this section that you are the authors of this proposal (as opposed to
soliciting in favor of a proposal submitted by another shareholder of the Company). You disclose this on the cover page, but it should be stated here, where you describe the proposal in greater detail.
Solicitation of Proxies, page 10
8. It appears that you intend to solicit proxies via mail, telephone, publication and electronic
means. Please be advised that all written soliciting materials, including any e-mails or scripts to be used in soliciting proxies must be filed under the cover of Schedule 14A on the date of first use. Refer to Rule 14a-6(b) and (c). Please confirm your understanding.
Kevin C. Tang
Tang Capital Management, LLC April 14, 2009 Page 3
9. We note your disclosure that you may
without seeking further approval of Vanda’s
stockholders seek reimbursement of the solicitation expenses from the Company. Please explain under what circumstances you would or would not do so.
Form of Proxy Card
10. Revise to include disclosure in boldface type that the proxy is not solicited on behalf of
the board of directors of Vanda Pharmaceuticals. Refer to Rule 14a-4(a).
11. Rule 14a-4(c)(3) contemplates the use of discretionary authority only for matters
unknown “a reasonable time before the solicitation.” Please clarify this on the proxy card.
* * *
Please amend the proxy statement in response to these comments. You may wish to
provide us with marked copies of the amendment to expedite our review. Please furnish a cover letter with the amendment that keys your responses to our comments and provides any requested supplemental information. Detailed cover letters greatly facilitate our review. Please understand that we may have additional comments after reviewing the amendment and responses to our comments.
We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filings reviewed by the staff to be certain that they have provided all material information to investors. Since the filing person is in possession of all facts relating to its disclosure, it is responsible for the accuracy and adequacy of the disclosures it has made.
In connection with responding to our comments, please provide, in writing, a statement
from the filing person acknowledging that:
• the filing person is responsible for the adequacy and accuracy of the disclosure in the
filings;
• staff comments or changes to disclosure in response to staff comments do not foreclose
the Commission from taking any action with respect to the filings; and
• the filing person may not assert staff comments as a defense in any proceeding initiated
by the Commission or any person under the federal securities laws of the United States.
In addition, please be advised that the Division of Enforcement has access to all
information you provide to the staff of the Divisi on of Corporation Finance in our review of your
filings or in response to our comments on your filings.
Kevin C. Tang
Tang Capital Management, LLC April 14, 2009 Page 4
Please direct any questions to me at (202) 551-3621 or, in my absence, to Christina
Chalk, Senior Special Counsel, at (202) 551-3263. You may also contact me via facsimile at
(202) 772-9203. Please send all correspondence to us at the following ZIP code: 20549-3628. S i n c e r e l y , Song Brandon Special Counsel Office of Mergers & Acquisitions
2006-04-07 - CORRESP - Vanda Pharmaceuticals Inc.
CORRESP
1
filename1.htm
J.P. MORGAN SECURITIES INC.
c/o J.P. Morgan Securities Inc.
277 Park Avenue
New York, NY 10172
April 7, 2006
Re:
Vanda Pharmaceuticals Inc.
Registration Statement on Form S-1
Registration File No. 333-130759
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Dear Sir/Madam:
In accordance with Rule 461 of the Securities Act of 1933, as amended (the “Act”), we hereby join in the request of Vanda Pharmaceuticals Inc. for acceleration of the
effective date of the above-named Registration Statement so that it becomes effective at 2:00 p.m. (New York time) on Tuesday, April 11, 2006, or as soon thereafter as practicable.
Pursuant to Rule 460 under the Act, please be advised that between March 28, 2006 and April 6, 2006, the undersigned effected the following approximate distribution of copies of the Preliminary Prospectus dated
March 28, 2006 (the “Preliminary Prospectus”):
No. of Copies
Prospective Underwriters
3,074
Dealers
173
Institutions
3,621
Others
2,148
Total
9,016
In connection with the Preliminary Prospectus distribution for the above-reference issue, the prospective underwriters have confirmed that they are complying with the 48-hour
requirement as promulgated by Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
Securities and Exchange Commission
2
April 7, 2006
Very truly yours,
J.P. MORGAN SECURITIES INC.
Acting severally on behalf of themselves
and the several Underwriters
By: J.P. Morgan Securities Inc.
By:
/s/ Richard Sesny
Name:
Richard Sesny
Title:
Vice President
2006-04-07 - CORRESP - Vanda Pharmaceuticals Inc.
CORRESP
1
filename1.htm
corresp
VANDA PHARMACEUTICALS INC.
9605 MEDICAL CENTER DRIVE
SUITE 300
ROCKVILLE, MARYLAND 20850
April 7, 2006
VIA EDGAR AND FACSIMILE
Securities and Exchange Commission
Division of Corporate Finance
450 Fifth Street, N.W.
Washington, D.C. 20549
Mail Stop 0601
Attn: Mary Fraser, Esq.
Re:
Vanda Pharmaceuticals Inc.
Registration Statement on Form S-1 (File No. 333-116384)
Dear Ms. Fraser:
Pursuant to Rule 461 under the Securities Act of 1933, as amended, Vanda Pharmaceuticals Inc.
hereby requests that the effective date of the above-referenced Registration Statement on Form S-1
be accelerated so that the Registration Statement may become effective at 2:00 p.m. Eastern Time on
Tuesday, April 11, 2006, or as soon thereafter as practicable.
The Company hereby acknowledges that:
•
should the Commission or the staff, acting pursuant to delegated
authority, declare the filing effective, it does not foreclose the
Commission from taking any action with respect to the filing;
•
the action of the Commission or the staff, acting pursuant to delegated
authority, in declaring the filing effective, does not relieve the Company
from its full responsibility for the adequacy and accuracy of the
disclosure in the filing; and
•
the Company may not assert the declaration of effectiveness as a
defense in any proceeding initiated by the Commission or any person under
the federal securities laws of the United States.
By separate letter, the underwriters of the issuance of the securities being registered will
join in this request for acceleration.
Securities and Exchange Commission
Division of Corporate Finance
April 7, 2006
Page 2
Thank you for your attention to this matter.
Very truly yours,
Vanda Pharmaceuticals Inc.
By:
/s/ Mihael H. Polymeropoulos, M.D.
Mihael H. Polymeropoulos, M.D.
Chief Executive Officer
cc:
Steven A. Shallcross, Vanda Pharmaceuticals Inc.
Jay K. Hachigian, Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP
Gregg A. Griner, Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP
Steven L. Baglio, Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP
Richard Truesdell, Davis Polk & Wardwell
Jeffrey Pohlman, Davis Polk & Wardwell
2006-03-28 - UPLOAD - Vanda Pharmaceuticals Inc.
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
Mail Stop 6010
March 9, 2006
Mihael H. Polymeropoulos, M.D.
Vanda Pharmaceuticals Inc.
9620 Medical Center Drive - Suite 201
Rockville, MD 20850
Re: Vanda Pharmaceuticals Inc.
Amendment No. 1 to Form S-1 Registration Statement
File No. 333-130759
Dear Dr. Polymeropoulos:
We have reviewed your filing and have the following
comments.
Where indicated, we think you should revise your document in
response
to these comments. If you disagree, we will consider your
explanation as to why our comment is inapplicable or a revision is
unnecessary. Please be as detailed as necessary in your
explanation.
In some of our comments, we may ask you to provide us with
supplemental information so we may better understand your
disclosure.
After reviewing this information, we may or may not raise
additional
comments.
Please understand that the purpose of our review process is
to
assist you in your compliance with the applicable disclosure
requirements and to enhance the overall disclosure in your filing.
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.
Use of Proceeds - page 26
1. We note the revisions you made in response to comment 19.
However, you did not address all of the issues we raised. Please
disclose how far along the development spectrum that you
anticipate
the proceeds will enable you to go. Also, disclose whether
material
amounts of additional funding will be necessary to achieve the
purposes you have identified. If so, disclose the amounts of
other
funds that will be necessary and the sources you will obtain them
from.
Capitalization - page 28
2. Please refer to your response to prior comment 22. The solid
lines
before and after "Accumulated deficit" were not moved to the
"Total
capitalization" line item as previously requested. Also, the
Total
stockholders` equity and Total capitalization lines do not foot
since
the table excludes amounts for accumulated other comprehensive
loss,
and the amount for actual deferred compensation appears to be
incorrect. Please revise or advise us.
Selected consolidated financial data - page 32
3. Please reinstate your balance sheet data disclosures as of
December 31, 2003. Please refer to Rule 301 of Regulation S-K.
Quantitative and qualitative disclosures about market risk - page
47
4. Based on your disclosure on page 39, it appears that you may be
subject to foreign currency exchange rate risk. Please provide
the
disclosures required by Rule 305 of Regulation S-K or disclose
that
your exposure to foreign currency exchange rate risk is not
material.
Critical accounting policies
Stock-based compensation - page 50
5. We are considering your response to prior comment 37. Please
note
we are deferring a final evaluation of stock compensation and
other
costs recognized until the estimated offering price is specified
and
we may have further comment in this regard when the amendment
containing that information is filed. Please address the
following:
a. We note in your response that you retroactively valued the
common
stock by discounting the estimated IPO price based on the timing
and
probabilities of major milestones or events compared to the
estimated
IPO price. Tell us the estimated IPO price, how you determined the
discount to the estimated IPO price and the significant
assumptions
used to forecast the probabilities of major milestones or events.
b. Since you did not obtain a contemporaneous valuation performed
by
an unrelated valuation specialist, please expand your disclosure
to
provide the following:
* Discuss the significant assumptions and methodologies used in
determining fair value.
* A discussion of each significant factor contributing to the
difference between the fair value as of the date of each grant and
the estimated IPO price.
* The reason management chose not to obtain a contemporaneous
valuation by an unrelated valuation specialist.
Business - page 53
License Agreements - page 65
6. We note your response to comment 28. It remains unclear as to
whether you have revised the disclosure to describe all material
rights and obligations under the BMS agreement. Please either
revise
the disclosure to include all material rights and obligations or
confirm that this is BMS` only material right under the agreement.
Principal stockholders - page 89
7. We have considered your response to comment 32. Please revise
the
footnotes to disclose the extent of the named persons` ownership
interest in each of the funds.
* * * * *
As appropriate, please amend your registration statement in
response
to these comments. You may wish to provide us with marked copies
of
the amendment to expedite our review. Please furnish a cover
letter
with your amendment that keys your responses to our comments and
provides any requested supplemental information. Detailed cover
letters greatly facilitate our review. Please file your cover
letter
on EDGAR under the form type label CORRESP. Please understand
that
we may have additional comments after reviewing your amendment and
responses to our comments.
You may contact Frank Wyman at (202) 551-3660, or Donald Abbott at
(202) 551-3608 if you have questions regarding comments on the
financial statements and related matters. Please contact Mary
Fraser
at (202) 551-3609, or me at (202) 551-3710 with any other
questions.
Sincerely,
Jeffrey P. Riedler
Assistant Director
Cc: Steven Baglio, Esq.
Gunderson Dettmer Stough Villeneuve Franklin & Hachigian LLP
610 Lincoln Street
Waltham, Massachusetts 94025
??
??
??
??
Mihael H. Polymeropoulos, M.D.
Vanda Pharmaceuticals Inc.
March 9, 2006
Page 4
</TEXT>
</DOCUMENT>
2006-01-27 - UPLOAD - Vanda Pharmaceuticals Inc.
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
Mail Stop 6010
January 27, 2006
Mihael H. Polymeropoulos, M.D.
Vanda Pharmaceuticals Inc.
9620 Medical Center Drive - Suite 201
Rockville, MD 20850
Re: Vanda Pharmaceuticals Inc.
Form S-1 Registration Statement
File No. 333-130759
Dear Dr. Polymeropoulos:
We have reviewed your filing and have the following
comments.
Where indicated, we think you should revise your document in
response
to these comments. If you disagree, we will consider your
explanation as to why our comment is inapplicable or a revision is
unnecessary. Please be as detailed as necessary in your
explanation.
In some of our comments, we may ask you to provide us with
supplemental information so we may better understand your
disclosure.
After reviewing this information, we may or may not raise
additional
comments.
Please understand that the purpose of our review process is
to
assist you in your compliance with the applicable disclosure
requirements and to enhance the overall disclosure in your filing.
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.
Comments applicable to the entire filing
1. We note that your filing contains numerous omissions throughout
the prospectus which relate to the offering price range or the
number
of shares you will sell. These omissions include but are not
limited
to:
* Summary Financial Data
* Use Of Proceeds
* Capitalization
* Dilution
* The Option Grants Table
* Shares Eligible For Future Sale
* The Principal Stockholders Table
* Description of Capital Stock
Rule 430A requires you to include this information in your filing
based upon an estimate of the offering price within a bona fide
range
you disclose on the cover page and based upon an estimate of the
number of shares you will sell. We consider a bona fide range to
be
$2 if the price is under $20 and 10% if it is above $20. You
should
include the required information in an amendment prior to
circulating
a "red herring" prospectus.
2. Provide us with copies of all the graphic, photographic or
artistic materials you intend to include in the prospectus prior
to
its printing and use. Please note that we may have comments.
Please
also note that all textual information in the graphic material
should
be brief and comply with the plain English guidelines regarding
jargon and technical language.
3. Although your exhibit index indicates that you are seeking
confidential treatment for a number of exhibits, you do not appear
to
have filed an application for confidential treatment. Please note
that Rule 406 of Regulation C specifies that the application is to
be
filed at the same time the registration statement is filed.
Please
file the application as soon as possible. We will not be in a
position to accelerate effectiveness of your registration
statement
until all issues relating to your confidential treatment request
have
been resolved.
4. In a number of places in your document you have used technical
jargon that is not likely to be understood by your readers.
Technical jargon should not appear in the forefront of the
prospectus. Please refer to Rule 421 of Regulation C. In the
remainder of the prospectus you should minimize the use of jargon.
If you cannot convey information without using jargon, please
explain
what the jargon means at the first place the terms appear. Here
are
some examples of technical jargon that needs to be replaced:
* Small molecule product candidates
* Differentiated new therapy
* Atypical antipsychotic
* Pivotal Phase III trial
* Melatonin agonist
* Injectable depot formulation
To the extent that these terms cannot be replaced by suitable
alternatives, please revise to explain the meaning of these terms
the
first time each one is used.
5. You have created a number of acronyms for use in this document
that are not likely to be familiar to your readers. The use of
acronyms is a convenience for the writer, but it forces readers to
learn a new vocabulary in order to understand the disclosure in
your
document. Please delete all of the acronyms except those which
can
be commonly found in general interest publications. Examples of
acronyms that should be deleted include:
* PG
* WASO
* CRSD
* NCE
* SNP
* PANSS
* BPRS
* LOCF
* MMRM
Prospectus Summary
6. In the last paragraph of page 1, the last paragraph of page 2,
the
first paragraph of page 3 and the fourth paragraph of page 3 you
present statistical and market share information related to your
proposed products. Please provide us with a copy of the
document(s)
containing the information you are relying on as support for these
statements. Mark the copy of the document to show the location of
each piece of information you are relying on. Provide similar
factual support for all similar claims made throughout the
registration statement. We may have additional comments after
reviewing the supporting documents.
7. In the third full paragraph of page 2 you refer to "our market
research." Please provide us with a copy of the research you are
referring to. It should be marked to show the location of the
information you are citing. We may have further comment after
reviewing the documentation.
8. We note your statement that you plan to partner with a global
pharmaceutical company for the development and commercialization
of
VEC-162 worldwide. If you have not yet identified a partner,
please
disclose this information here and in the "Business" section of
your
document. Also, disclose that Bristol Meyers Squibb has the right
to
commercialize VEC-162 on its own if you have not entered into a
partnering arrangement after the completion of your Phase III
program.
9. Similarly, in the summary discussion of the risks associated
with
your business, disclose that your agreements with Novatis provides
Novartis with the ability to terminate your agreements if you fail
to
meet development or commercialization milestones and that your
agreement with Bristol Meyers Squibb allows Bristol Meyers Squibb
to
commercialize VEC-162 on its own if you have not entered into a
partnership arrangement.
10. Supplementally explain why you believe your PG expertise is
unique and how it will provide you with preferential access to
compounds discovered by other pharmaceutical companies and how it
will allow you to shorten the drug development timeline relative
to
other traditional approaches.
Summary consolidated financial data, page 6
11. Please expand your disclosures in the introductory paragraph
to
clarify that in addition to the pro forma balance sheet you
include
pro forma net loss per share data.
Risk Factors - page 8
We face substantial competition which may result in others
developing
or commercializing products before or more successfully than we
do. -
page 14
12. The information in this risk factor is too generic to be
informative to an investor. Please identify the existing products
that your proposed products will compete with. Also, since you
are
aware of other companies engaged in the development of potentially
competitive products, identify those proposed products and their
manufacturers and indicate, to the extent you are aware, the
development stage of the proposed products.
Product liability lawsuits could divert our resources, result in
substantial liabilities and reduce the commercial potential of our
products. - page 16
13. We note your statement that your insurance may not fully cover
potential liabilities. Please revise to disclose the limitations
on
your insurance coverage. Similarly, revise "If we use hazardous
and
biological materials in a way that causes injury or violates
applicable law, we may be liable for damages."
Our rights to develop and commercialize our product candidates are
subject in part to the terms and conditions of licenses or
sublicenses granted to us by other pharmaceutical companies... -
page
18
14. We note that if you fail to meet milestones described in your
licensing agreements with Novartis, your rights to develop and
commercialize iloperidone and VSF-173 may terminate. Revise to
describe the milestones here and in the description of the
licensing
agreements beginning on page 63.
15. In the next to last sentence of the first paragraph you state
that your rights to develop and commercialize iloperidone may be
impaired if you do not cure breaches by Novartis and Titan of
similar
obligations contained in these sublicense and license agreements.
This suggests that there is an outstanding breach. If so, please
describe it in reasonable detail along with the steps you have
taken
to cure the breach. If there is no breach, please revise the
language to eliminate the suggestion that there is one.
A substantial number of shares of our common stock could be sold
into
the public markets shortly after this offering, which could
depress
our stock price. - page 21
16. Please revise to quantify the number of outstanding shares
that
will be eligible to be sold into the public markets.
Existing stockholders significantly influence us and could delay
or
prevent an acquisition by a third party. - page 23
17. Please expand the risk factor to discuss the risk of
management
entrenchment.
Completion of this offering may limit our ability to use our net
operating loss carryforwards. - page 24
18. Please quantify the disclosure in this risk factor.
Use of Proceeds - page 26
19. Please refer to Item 504 of Regulation S-K. You need to
significantly expand the information included in the second
paragraph
of the discussion to identify the specific research and potential
products that you will use the proceeds for. Disclose the
specific
amounts that you intend to spend on each of "research," "pre-
clinical
development" and "clinical trials" and how far along the
development
spectrum that you anticipate the proceeds will enable you to go.
Disclose whether material amounts of additional funding will be
necessary to achieve the purposes you have identified. If so,
disclose the amounts of other funds that will be necessary and the
sources you will obtain them from.
20. You say that the "balance" of the net proceeds will be used
for
general corporate purposes, including working capital and the
acquisition of pharmaceutical products and businesses that are
complementary to your own. Please be more specific about what
these
purposes are and the amount you will use for each purpose. We may
have additional comments after reviewing your response.
Capitalization, page 27
21. It appears that your pro forma capitalization table should
include the Series B Preferred Stock issued on December 9, 2005.
Please revise your disclosures or disclose, and explain to us, why
the Series B Preferred Stock issued on December 9, 2005 is
excluded
from the pro forma capitalization table. Your pro forma column
should give effect to events that have taken place and the pro
forma
as adjusted column should include events that are contingent on
the
offering.
22. Please refer to your tabular disclosures. It appears that the
solid lines before and after "Accumulated deficit" should be moved
to
the "Total capitalization" line item. Please revise or advise us.
Dilution, page 28
23. It appears that the pro forma net tangible book value amounts
should include the Series B Preferred Stock issued on December 9,
2005. Please revise your disclosure or disclose, and explain to
us,
why the Series B Preferred Stock issuance is excluded from the pro
forma amounts.
Management`s discussion and analysis of financial condition and
results of operations
Overview, page 32
24. We note that while you are unable to estimate the specific
timing
and future costs of your clinical development program, your Phase
III
trials for Iloperidone began in November 2005 and you expect them
to
be completed by early 2007. If these trials are successful, you
believe that the related data will support US and European
regulatory
filings. Please disclose the following information for your
research
and development activities related to Iloperidone:
a. The nature, timing and estimated costs of the efforts necessary
to
complete this project;
b. The consequences to operations, financial position and
liquidity
if this project is not completed timely;
c. The period in which material net cash inflows from this project
are expected to commence assuming successful filings with US and
European regulators.
Regarding a., disclose the amount or range of estimated costs and
timing to complete the phase in process and each future phase. To
the
extent that information is not estimable, disclose those facts and
circumstances indicating the uncertainties that preclude you from
making a reasonable estimate. Please revise your contractual
obligations and commitment disclosures starting on page 44, as
appropriate.
Critical accounting policies
Revenue recognition, page 48
25. We note that you discuss revenue earned under research and
development contracts. It appears that these types of contracts
are
no longer material since you disclose that Vanda completed its
obligations under these types of consulting agreements during the
year ended December 31, 2004, and no longer seeks such
arrangements.
Please clarify why revenue earned under research and development
contracts is a critical accounting policy to explain this
inconsistency. If you believe this revenue recognition policy is
critical, it appears that an output-based approach is the
appropriate
model to estimate performance under the contract rather than using
an
input measure, such as cost. If costs incurred compared to total
estimated costs over the development period approximates the
proportion of the value of the services provided compared to the
total estimated value over the development period, please clarify
your disclosure. Revise your disclosures in Note 2 to the
consolidated financial statements, as appropriate.
Business - page 51
Potential advantages of iloperidone - page 54
26. In the carryover paragraph at the top of page 55 you reference
"market research we conducted with LEK Consulting." Rule 436 of
Regulation C indicates that where a report of an expert is
summarized
in the registration statement, the written consent of the expert
summarized in the document shall be filed as an exhibit to the
registration statement. Please include the written consent of LEK
Consulting in your first amendment to the registration statement.
Also, please provide us with a copy of the document you are
summarizing.
License Agreements - page 63
27. We note that you have not yet filed the license agreements
described under this heading. Please file them with your first
amendment. We may have comments regarding the disclosure about
these
agreements once we review them.
28. We note your use of BMS` right to commercialize VEC-162 on its
own if you have not entered into a partnering arrangement after
the
completion of the Phase III program as an example of BMS` rights
with
respect to VEC-162. All of BMS` material rights and obligations,
as
well as your material rights and obligation, should be described
in
this discussion. Please revise to describe all rights and
obligations or revise to clarify that this in BMS` only material
right under the agreement.
Patents and proprietary rights; Hatch-Waxman protection - page 69
29. Please explain what a "new chemical entity" patent is and
differentiate it from other patents.
Management - page 72
Executive compensation - page 76
30. Please update this disclosure to include 2005 compensation
information, as well as the 2004 information.
Principal stockholders - page 86
31. Please identify the natural person holding voting and
ownership
control over the shares owned by each non-natural person included
in
the ownership table.
32. Please
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