SEC Comment Letter for ALNYLAM PHARMACEUTICALS, INC. (ALNY) (CIK 0001178670) (ALNY) — Feb 11, 2011
ALNYLAM PHARMACEUTICALS, INC. (ALNY) (CIK 0001178670)
Date: Feb. 11, 2011 · CIK: 0001178670 · Accession: 0000000000-11-009464
AI Filing Summary & Sentiment
Reasoning
File numbers found in text: 000-50743
Letter
Re: Alnylam Pharmaceuticals, Inc. Form 10-K Filed February 26, 2010 File No. 000-50743 Dear Mr. Maraganore: We have reviewed your response letter da ted January 12, 2011 and have the following comments. Please respond to this letter within te n business days by providing the requested information, or by advising us when you will provide the requested response. If you do not believe our comments apply to your facts and circum stances, please tell us w hy in your response. After reviewing the information you provide in response to these comments, we may have additional comments. Form 10-K, filed February 26, 2010
February 11, 2011
John M. Maraganore, Ph.D. Chief Executive Officer Alnylam Pharmaceuticals, Inc. 300 Third Street Cambridge, MA 02142
Business, page 2
1. We note your response to our prior comment 1 and your disclosure regarding your license agreement with Max Planck Innovation that you will be required to pay future royalties on net sales of all therapeutic and prophylactic products. Please revise your disclosure to include a range of royalty rates not to ex ceed ten percent. An acceptable range of royalties is one of the following: “single-digits,” “teens,” “twenties,” etc. Kyowa Hakko Kirin, page 20
2. We note your response to our prior comme nt 2 that under the Kyowa Hakko Kirin agreement, there are modest development and sa les milestone payments and royalty rates. However, we also note in your 2009 Form 10-K that Kyowa Hakko Kirin paid you an upfront cash payment of $15 million and is required to make payments to you upon achievement of specified development sales milestones totaling up to $78 million in addition to royalty payments based on annual net sales. These amounts do not appear to
John M. Maraganore, Ph.D. Alnylam Pharmaceuticals, Inc. February 11, 2011 Page 2
be modest given that you had revenues of approximately $100 million and net losses of approximately $47.6 million in 2009. Please file as an exhibit to your 2010 Form 10-K, the license and collaboration agreement with Kyowa Haddo Ki rin dated June 2008.
Delivery Initiatives, page 24
3. We note your response to our prior comment 3 and your disclosure that Tekmira and Protiva are eligible to receive royalty pa yments on annual product sales for each RNAi therapeutic formulated using Tekmira’s or Protiva’s liposomal delivery formulation technologies, and that you ar e eligible to receive royal ties on annual sales of RNAi therapeutic products for which you granted Tekm ira and Protiva licenses. Please revise your disclosure to include a ra nge of royalty rates not to ex ceed ten percent for royalties that you will pay to and receive from Tekm ira and Protiva. An acceptable range of royalties is one of the fo llowing: “single-digits,” “teens,” “twenties,” etc.
Proxy Statement on Schedule 14A, filed April 20, 2010 2009 Annual Incentive Program, page 26
4. We note your response to our prior comme nt 5 and your disclosure regarding 2010 corporate goals and individual objectives. We also note your discussion of Ms. Allen’s individual objectives which are partly fo cused on meeting specified financial goals, including meeting specified operating expense levels and minimum cash balance requirements at year-end. These objectives appe ar to be quantitative. To the extent that the objectives are quantitative, please revise your disclosure so that the discussion of objectives and achievements is also quantitative. You may contact Johnny Gharib at (202) 551-3170 or me at (202) 551-3715 if you have any questions. Sincerely, Jeffrey Riedler Assistant Director
Show Raw Text
February 11, 2011
John M. Maraganore, Ph.D. Chief Executive Officer Alnylam Pharmaceuticals, Inc. 300 Third Street
Cambridge, MA 02142
Re: Alnylam Pharmaceuticals, Inc. Form 10-K
Filed February 26, 2010 File No. 000-50743
Dear Mr. Maraganore:
We have reviewed your response letter da ted January 12, 2011 and have the following
comments.
Please respond to this letter within te n business days by providing the requested
information, or by advising us when you will provide the requested response. If you do not believe our comments apply to your facts and circum stances, please tell us w hy in your response.
After reviewing the information you provide in response to these comments, we may
have additional comments.
Form 10-K, filed February 26, 2010
Business, page 2
1. We note your response to our prior comment 1 and your disclosure regarding your license agreement with Max Planck Innovation that you will be required to pay future royalties
on net sales of all therapeutic and prophylactic products. Please revise your disclosure to
include a range of royalty rates not to ex ceed ten percent. An acceptable range of
royalties is one of the following: “single-digits,” “teens,” “twenties,” etc.
Kyowa Hakko Kirin, page 20
2. We note your response to our prior comme nt 2 that under the Kyowa Hakko Kirin
agreement, there are modest development and sa les milestone payments and royalty rates.
However, we also note in your 2009 Form 10-K that Kyowa Hakko Kirin paid you an
upfront cash payment of $15 million and is required to make payments to you upon
achievement of specified development sales milestones totaling up to $78 million in addition to royalty payments based on annual net sales. These amounts do not appear to
John M. Maraganore, Ph.D. Alnylam Pharmaceuticals, Inc. February 11, 2011 Page 2
be modest given that you had revenues of approximately $100 million and net losses of
approximately $47.6 million in 2009. Please file as an exhibit to your 2010 Form 10-K,
the license and collaboration agreement with Kyowa Haddo Ki rin dated June 2008.
Delivery Initiatives, page 24
3. We note your response to our prior comment 3 and your disclosure that Tekmira and
Protiva are eligible to receive royalty pa yments on annual product sales for each RNAi
therapeutic formulated using Tekmira’s or Protiva’s liposomal delivery formulation
technologies, and that you ar e eligible to receive royal ties on annual sales of RNAi
therapeutic products for which you granted Tekm ira and Protiva licenses. Please revise
your disclosure to include a ra nge of royalty rates not to ex ceed ten percent for royalties
that you will pay to and receive from Tekm ira and Protiva. An acceptable range of
royalties is one of the fo llowing: “single-digits,” “teens,” “twenties,” etc.
Proxy Statement on Schedule 14A, filed April 20, 2010
2009 Annual Incentive Program, page 26
4. We note your response to our prior comme nt 5 and your disclosure regarding 2010
corporate goals and individual objectives. We also note your discussion of Ms. Allen’s
individual objectives which are partly fo cused on meeting specified financial goals,
including meeting specified operating expense levels and minimum cash balance requirements at year-end. These objectives appe ar to be quantitative. To the extent that
the objectives are quantitative, please revise your disclosure so that the discussion of
objectives and achievements is also quantitative.
You may contact Johnny Gharib at (202) 551-3170 or me at (202) 551-3715 if you have
any questions.
Sincerely,
Jeffrey Riedler
Assistant Director