SEC Comment Letter for MetaMorphix Inc. (CIK 0001289370) — Jun 2, 2005
MetaMorphix Inc. (CIK 0001289370)
Date: June 2, 2005 · CIK: 0001289370 · Accession: 0000000000-05-027288
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File numbers found in text: 000-51294
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Mail Stop 3561
June 2, 2005
Dr. Edwin C. Quattlebaum, CEO
MetaMorphix, Inc.
8000 Virginia Manor Road Suite 140
Beltsville, Maryland 20705
Re: Metamorphix, Inc.
Registration Statement on Form 10-SB
Filed May 2, 2005
File No. 000-51294
Dear Mr. Quattlebaum:
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.
Forward-Looking Statements, page 1
1. Please clarify to disclose that the safe harbors for forward-
looking statements included in the Securities Act and Securities
Exchange Act do not apply to statements made in your Form 10-SB.
Part I, page 2
Item 1. Description of Business, page 2
2. Please describe the development of the business as required by
Item 101(a) of Regulation S-B. Also, please provide a discussion
of
the actual products and services you have developed to date.
3. In describing your business, you employ many technical terms
and
jargon throughout this section that may be confusing and difficult
for an average reader to understand. For example, we note the
terms
"growth differentiation factors," "Cachexia," "genotyping,"
bioinformatics, "SNP," "nucleotide" etc. Please review this
section
for technical terms or jargon and significantly revise the
business
section to explain in greater detail your principal products and
services. Where technical terms or jargon are used, please either
explain when first used or remove any technical terms or jargon.
4. For each of the products, please describe how the company
develops
the product or the technology.
5. For each of the agreements discussed in the business section,
please discuss the material terms of the agreement, including the
duration.
Animal Genomics, page 2
6. We note that parts of the business section appear promotional,
rather than factual, and should be revised to remove all
promotional
statements. No speculative information should be included, unless
clearly labeled as the opinion of management of the company along
with disclosure of the reasonable basis for such opinions or
beliefs.
For example we note the statements in the first paragraph of this
subsection such as "projected to be the dominant future
technologies
for livestock production and animal and human health." Also see
the
statement on page 3 in the third paragraph that "would result not
only in substantial cost savings." Please provide reasonable
support
for the promotional statements in the prospectus. If a reasonable
basis cannot be provided, the statements should be removed.
Myostatin, page 4
7. In this subsection, we note that you make several assertions
regarding market conditions. Please provide us with reasonable
support for the following assertions and summarize the support in
the
prospectus. If a third party is the source of the information,
please name the third party and the publication where the
information
can be found. We note the following:
* "We expect our Myostatin-based technology to benefit the global
livestock industry dramatically by improving production
efficiencies,
reducing production time, improving quality and nutritional value
and
decreasing the production of animal waste;"
* "Producing animals with up to 8% to 21% more meat;"
* "Improving the feed conversion ratio . . . by as much as 10%;"
* "Decreasing the time required to reach a target weight by 10% to
25%;"
* "Producing higher quality meat, including meat with 50% less fat
content, higher protein content, improved tenderness and better
flavor;"
* "Reducing animal waste;" and
* "Accelerating market branding of animal food products."
If you cannot provide us with adequate support for these
assertions,
you should delete them.
Other GDFs in Development, page 5
8. Please provide the reasonable basis for the statements "[w]e
believe that a potential agricultural use for GDF-9 could be the
regulation of livestock fertility, while potential human uses
include
the treatment of infertility and nonsteroidal contraception. In
addition, GDF-12 had been found to play a specific role in liver
growth and development and could be used in the treatment of liver
diseases such as cirrhosis, hepatitis and liver cancer."
Human Applications, page 5
9. In the second paragraph of this subsection, please describe the
"numerous scientific studies."
Animal Genomics, page 6
Celera Acquisition, page 6
10. Please describe the assets that the company acquired from
Celera
Genomics Group of Applera.
11. Please describe the obligation to pay Celara a percentage of
any
economic consideration that the company receives from a contract
or
business relationship in the cattle area for 15 years. Also
describe
the percentage of any consideration that Celara will receive from
a
collaboration entered into prior to February 28, 2006 in the swine
or
poultry area.
12. Please explain the example on page 6 whereby you received $1
million from a swine collaborative partner and were required to
pay
$1 million to Celera. Are you required to pay 100% of the amount
from collaborative partners? Is this inclusive of the $500,000
annual payment? Also, why would $1 million be excluded from the
calculation of revenue sharing payment rather than the $500,000?
Please clarify.
Cargill Agreement, page 7
13. Please describe when the company may enter into the Joint
Commercialization Agreement with Cargill and the duration of the
agreement.
14. Please describe the "defined period" in which Cargill will
have
the exclusive right to use the joint intellectual property on a
commercial scale.
Monsanto Agreement, page 7
15. Please describe in more detail the fee arrangement and the
principal terms of the agreement between the company and Monsanto
Company.
Growth Differentiation Factor Technology, page 7
Amended and Restated Collaboration Agreement with Genetics
Institute
and The John Hopkins University, page 7
16. Please refer to the first paragraph on page 8. Please
describe
in more detail the milestone payments and the royalties.
17. Please refer to the fourth paragraph, last sentence, on page
8.
Please describe the penalty interest rate. Please disclose any
action that may result from the default, including the possibility
that the agreement may not be extended. Please disclose the
current
expiration date of the agreement.
Chicken Commercial Licensing, page 9
18. Please describe in more detail the "Letters of Intent" and
"Limited Licenses Agreements" and name the two chicken producers.
Additional Technology, page 9
Immunopharmaceuticals, page 9
19. Please describe in more detail the royalty payments to VIDO
under the license agreement.
Patents and Proprietary Rights, page 10
20. Please describe the nature of the patents and whether the
company
holds joint ownership with or licenses any patents. Please
discuss
the importance to your business of the patents.
Government Regulation, page 10
21. Please describe the company`s products which have been
approved
by the FDA and include the dates of approval. Please describe
those
products which the company is currently seeking FDA approval and
describe the steps necessary to obtain approval. Also include
those
products in which the company will seek in the near future FDA
approval.
22. Please describe any approval necessary for the company`s
products
by the U.S. Department of Agriculture.
Foreign Regulation and Product Approval, page 12
23. Please describe the company`s products which have been
approved
or are currently in the process of being approved by foreign
regulatory authorities.
Marketing and Sales, page 13
24. Please describe the markets for the company`s products such as
the region of the country that the products are offered or if the
products are offered in other countries.
Competition, page 13
Animal Genomics, page 13
25. Please describe the company`s competitive position in the
industry. See Item 101(b)(4) of Regulation S-B.
Employees, page 14
26. Please include the number of total employees, including part-
time
employees.
Other
27. On page F-14, we note the discussion of the "Myostatin Chicken
Commerical Licensing." Please describe the fees and the principal
terms of this agreement in the Description of Business section.
28. Please describe the company`s dependence on one or a few major
customers. See Item 101(b)(6) of Regulation S-B.
29. Please describe the costs and effects of compliance with
environmental laws. See Item 101(b)(11) of Regulation S-B.
Risk Factors, page 14
We require additional funding and may be unable to obtain funding
on
acceptable terms, page 14
30. Please disclose the cash balance as of the most recent
practicable date.
31. Please provide the basis for the statement that you believe
you
will generate positive cash flow from operations during 2006 or
remove. We direct you to Item 10(d) of Regulation S-B regarding
the
Commission`s position on projections.
We have substantial outstanding indebtedness including amounts
owed
to members of current and former management that we may be unable
to
repay or convert to equity, page 15
32. You state, "[a]t December 31, 2004, we had approximately
$20,960,000 of outstanding indebtedness in the form of short-term
and
long-term promissory notes. Of such amount, $1,605,293 principal
amount is past due and an additional $954,563 is considered short-
term debt." We note that the balance sheet reflects $11,399,886
in
long term notes payable and $1,623,824 in short term notes
payable.
Please reconcile the amounts disclosed in the Risk Factors
discussion
to the amounts disclosed in the financial statements and notes
thereto.
Our success in developing our product candidates depends upon the
performance of our licensees and collaborative partners, page 16
33. Please revise the risk factor subheading to describe the risk
that is discussed in the narrative.
Our preferred stockholders may have control over our actions, page
20
34. We note that the risk factor subheading states that the
preferred
stockholders may have control over the company`s actions.
However,
it appears that the preferred stockholders will have control over
such actions. Please revise. Also, please disclose the percent
of
voting control held by the series E preferred stock.
35. Please add a separate risk factor discussing the going concern
raised by the independent auditors` report.
Item 2. Management`s Discussion and Analysis or Plan of
Operation,
page 21
Overview, page 21
36. We believe your MD&A section could benefit from an expanded
"Overview" section that offers investors an introductory
understanding of MetaMorphix and the matters with which management
is
concerned primarily in evaluating the company`s financial
condition
and operating results. A good introduction, accordingly, might
include a discussion of the following: the economic or industry-
wide
factors relevant to the company; a discussion of how the company
earns or expects to earn revenues and income; the identity of the
company`s primary business lines, location(s) of operations and
principal services; and insight into material opportunities,
challenges, risks, and material trends and uncertainties. To the
extent known, provide insight into challenges, risks and
opportunities of which management is aware and discuss any actions
being taken to address the same. For a more detailed discussion
of
what is expected in both this subheading and the MD&A section in
general, please refer to: <http://www.sec.gov/rules/interp/33-
8350.htm>. See also, Item 303 of Regulation S-B.
Critical Accounting Policies, page 21
37. We note your disclosure of the company`s Critical Accounting
Policies. Please note this disclosure is supposed to supplement,
but
not duplicate, the description of accounting policies in the notes
to
the financial statements and provide greater insight into the
quality
and variability of information regarding financial condition and
operating performance. Refer to SEC Release 33-8350, available at
www.sec.gov./rules/interp/33-8350.htm and revise accordingly.
38. In connection with our comment above, expand the discussion of
the company`s revenue recognition policies to clarify the method
used
to recognize revenue from parentage and identification genotyping
services. Disclose the significant terms and conditions of these
service contracts and explain the basis for the company`s method
of
revenue recognition.
39. Expand the discussion of the company`s revenue recognition
policies to clarify the method used to recognize revenue from
milestone payments from collaborative partners and licensees.
Disclose significant terms and conditions in the company`s
agreements, and explain the company`s basis for use of the
straight-
line method for certain arrangements. Disclose the method of
revenue
recognition used for arrangements where the company`s level of
effort
is not considered "relatively constant over the performance
period."
Explain what is meant by "the determination of the performance
period
involves judgment by management."
40. Disclose the specific revenue recognition policies for upfront
payments received from collaborative partners and licensees,
including the $1 million license fee received in June 2004 from
Monsanto Company. Describe the significant terms and conditions
of
the arrangements, including, for example, the five year license
exclusivity period and other terms of the Monsanto Agreement.
41. Expand the discussion of revenue recognition policies to
quantify
the amount of revenue earned during the periods presented for each
of
the company`s principal sources of revenues, including parentage
and
identification genotyping services, upfront and milestone payments
from collaborative partners and licensees, and other sources or
types
of arrangements.
Liquidity and Captial Resources, page 25
42. Update to provide an explanation for the net change in cash
from
operating, investing and financing activities.
43. Discuss any trends, events or uncertainties to have a material
impact on short term or long term liquidity.
44. Disclose the company`s issuance of warrants to satisfy
penalties
due to the delay of paying noteholders.
45. Please disclose the cash balance as of the most recent
practicable date and disclose how long you can satisfy your cash
requirements.
Results of Operations, page 26
46. Please disclose that there is no guarantee that revenues will
increase significantly or that these technologies currently under
collaborative research projects will be commercialized. Lastly,
please include disclosure immediately following this disclosure
warning investors about placing undue certainty on projections.
47. Please include a comparison of the net losses.
Item 3. Description of Property, page 28
48. Please include the payment amounts under each lease agreement.
Item 4. Security Ownership of Certain Beneficial Owners and
Management, page 29
49. We note the disclosure in footnote three that the percent of
ownership is based on the number of shares outstanding assuming
conversion of the preferred st