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SEC Comment Letter for Adams Respiratory Therapeutics, Inc. (CIK 0001319439) — Apr 22, 2005

Adams Respiratory Therapeutics, Inc. (CIK 0001319439)
Date: April 22, 2005 · CIK: 0001319439 · Accession: 0000000000-05-019886

AI Filing Summary & Sentiment

File numbers found in text: 333-123585

Date
April 22, 2005
Author
Not clearly detected
Form
UPLOAD
Company
Adams Respiratory Therapeutics, Inc. (CIK 0001319439)

Letter

Via Facsimile and U.S. Mail Mail Stop 03-09 April 22, 2005 Walter E. Riehemann Vice President & General Counsel Adams Laboratories, Inc. 425 Main Street Chester, New Jersey 07930

Re: Adams Laboratories, Inc. Registration Statement on Form S-1 Filed March 25, 2005 File Number 333-123585

Dear Mr. Riehemann:

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.

FORM S-1

General

1. We note your graphic following the cover page of the prospectus. Please provide us with proofs of all graphic, visual, or photographic information you will provide in the printed prospectus prior to its use. Please note we may have comments regarding any additional graphics or visuals you may include.

2. Please note that when you file a pre-effective amendment containing pricing-related information, we may have additional comments. As you are likely aware, you must file this amendment prior to circulating the prospectus.

3. Please note that when you file a pre-effective amendment that includes your price range, it must be bona fide. We interpret this to mean that your range may not exceed $2 if you price below $20 and 10% if you price above $20.

4. Please note that where we provide examples to illustrate what we mean by our comments, they are examples and not complete lists. If our comments are applicable to portions of the filing that we have not cited as examples, please make the appropriate changes in accordance with our comments.

5. We note that you have requested confidential treatment for several of your exhibits under Rule 406 of the Securities Act; we will furnish comments for your request under separate cover. Please be advised, we will not act on any request for acceleration of effectiveness until we have cleared comments on your request for confidential treatment.

6. Please provide a substitute for or explain the term "BID" in the graphic immediately preceding the back cover page of the prospectus.

7. We note your statement in the graphic, "[t]he ONLY BID bi-layer tablet to enhance patient compliance." Supplementally, please explain why Mucinex enhances patient compliance.

Prospectus Summary, page 1

8. As you have chosen to include a summary of your strategy, please balance this discussion by including a discussion of the risks and obstacles you must address in implementing this strategy. This discussion should be at least as prominent as the discussion of your strategy.

9. Please provide a brief discussion of the FDA`s policy of removing unapproved competing products from the market once a similar product has been approved. The discussion should address why the competitors were permitted to sell unapproved drugs and whether the determinative factor was the FDA approval or that your products are sold over the counter and the competing products were available by prescription only.

10. We note your statement, "our current products and products in development or being considered for development will compete in many of the segments included in this combined OTC and prescription market that totals approximately $3.9 billion." You should only include the size of your potential target market in which you will compete. Please confirm the $3.9 billion accurately reflects your target market or revise accordingly.

11. Please revise to disclose that Cardinal Health is not currently meeting your manufacturing requirements.

12. In the summary and throughout your filing you reference reports relating to the size of the industry, and your position within the industry. Please provide us with supplemental copies of these reports. These reports should be marked to indicate the supporting information.

Risk Factors 13. Please include a separate stand alone risk factor to disclose any known side effects of Mucinex SE and Mucinex DM.

We depend heavily on the success of our existing products ..., page 7

14. Many of the bullet points included in this risk factor are discussed as separate stand alone risks. Please revise to eliminate the redundancy by deleting the bullet points that are discussed more fully in the risk factor section. Similarly, revise "We may not be successful in our efforts to expand our portfolio of Products."

We do not have our own manufacturing capability and rely on Cardinal Health ..., page 7

15. Please revise your heading to disclose that recently Cardinal Health has not been able to manufacture sufficient quantities of your product meet your demand.

16. Please revise your disclosure to indicate you may never find another suitable source of supply that meets your needs to manufacture the Mucinex SE or Mucinex DM.

We and Cardinal Health depend on a single supplier for guaifenesin, the active ..., page 8 17. If obtaining needed supplies has ever caused a material delay or disruption to your business, please discuss.

18. Please identify the circumstances that would allow Boehringer Ingelheim to raise its prices.

19. Are there any provisions in your agreement with Cardinal Health that would allow you to obtain inventory from another source. If the agreement does not contain such provisions, please disclose this information here. If the agreement does contain such provisions, please provide a description of these provisions in the appropriate location in your Business section.

20. We note that Cardinal Health`s agreement with Boehringer Ingelheim allows Cardinal Health the limited ability to enter into agreements with other parties. Please briefly describe the limitations.

We face substantial competition that may prevent us from maintaining or increasing ..., page 10 21. To the extent easily obtainable, please disclose your competitors` share of the target market.

Product liability lawsuits could divert our resources, result in substantial liability ..., page 11 22. Please disclose the amount of your insurance coverage, or in the alternative, please indicate if you believe such coverage amount is reasonably adequate to insulate you from potential product liability claims.

If we fail to obtain an adequate level of reimbursement for our products ..., page 12

23. Please revise your heading to disclose that many states do not cover the costs of your products.

We depend on our key personnel and if we are not able to retain ..., page 16

24. To the extent known, please disclose the projected time frame of your hiring the additional technical personnel. 25. If you have had problems attracting or retaining qualified employees, please revise to describe the problems you have experienced. Additionally, if any key employee has plans to retire or leave your company in the near future, please revise the discussion to disclose this information.

We may undertake strategic acquisitions of technologies and products. Integration ..., page 16 26. Please revise your risk factor to disclose that you may not have the necessary funds or resources to complete acquisitions. You should also highlight your lack of experience in identifying and completing acquisitions.

If we are unable to protect the intellectual property rights related ..., page 17

27. Please revise to disclose, even an unsuccessful infringement action against you may be expensive to defend.

If we are unable to protect the confidentiality of our trade secrets ..., page 18 28. If your business has been materially and adversely affected by the disclosure of proprietary information, please discuss the situation and its consequences.

Legal proceedings or third party claims of intellectual property ..., page 18

29. To the extent you are aware of any intellectual proprietary rights that are being infringed upon or that you have been notified a third party`s belief that you are infringing on their patent(s), please revise to disclose the situation and potential consequences.

An active trading market for our common stock may not develop, page

30. Please revise the statement that you expect your common stock to be approved for quotation on the Nasdaq National Market to state that you have applied for quotation or intend to apply for quotation as opposed to stating that you expect to be approved.

We will incur increased costs as a result of being a public company and our ..., page 21 31. As currently written, this risk factor discussion could apply to any issuer that is becoming a reporting company. See Item 503(c) of Regulation S-K. Please revise to tailor the discussion to your company. For example, you could provide an estimate of the increase in expenses related to being a public company, discuss any difficulties you have encountered in attracting directors, etc.

Use of Proceeds, page 34

32. Please disclose the approximate amount and timing of the proceeds you plan to use for the purposes you list in this section. We note you plan to use some proceeds for continued branding of Mucinex. Please disclose the specific amounts from your offering proceeds that you intend to allocate for such purpose. Additionally, please specify how much you anticipate spending for product development, which products you expect to develop using these proceeds and indicate where in the drug development process you expect to be after the expenditure of these proceeds.

33. Please identify with more specificity the uses that you currently categorize as "general corporate purposes," and state how much of the proceeds you plan to put toward each such use.

Management`s Discussion and Analysis of Financial Condition and Results of Operations

Critical Accounting Policies and Estimates

Sales Returns and Allowances, pages 30 - 31

34. We believe that your disclosure related to estimates that reduce gross revenue such as product returns, cash discounts, rebates chargebacks, and sale incentives could be improved as follows: a) Disclose the nature and amount of each accrual at the balance sheet date and the effect that could result from using other reasonably likely assumptions than what you used to arrive at each accrual such as a range of reasonably likely amounts or other type of sensitivity analysis. b) We note that you have disclosed the factors you consider in establishing your product returns and other sales allowances. To the extent that information you consider is quantifiable, disclose both quantitative and qualitative information and discuss to what extent information is from external sources (e.g., end-customer prescription demand, third-party market research data comparing wholesaler inventory levels to end-customer demand). For example, in discussing your estimate of product that may be returned, consider disclosing and discussing, preferably by product and in tabular format, the total amount of product (in sales dollars) that could potentially be returned as of the balance sheet date and disaggregated by expiration period. c) If applicable, discuss any shipments made as a result of incentives and/or in excess of your customer`s ordinary course of business inventory level. Discuss your revenue recognition policy for such shipments. d) You should consider disclosing a roll forward of the accrual for each estimate for each period presented showing the following: ? Beginning balance, ? Current provision related to sales made in current period, ? Current provision related to sales made in prior periods, ? Actual returns or credits in current period related to sales made in current period, ? Actual returns or credits in current period related to sales made in prior periods, and ? Ending balance.

e) In your discussion of results of operations for the period to period revenue comparisons, discuss the amount of and reason for fluctuations for each type of reduction of gross revenue, such as product returns, chargebacks, customer rebates and other discounts and allowances, including the effect that changes in your estimates of these items had on your revenues and operations.

Cardinal Health Profit Share, page 31

35. We note from your disclosure that direct manufacturing cost plus the mark-up are merely provided for interim billing purposes. This would seem to infer that that the actual cost of the inventory purchased from Cardinal is the percentage of the profit that Cardinal receives. Please explain to us and cite the authoritative guidance used under US GAAP why the inventory is recorded as the direct manufacturing cost plus the mark-up.

36. Based on your disclosure, cost of sales represents the direct manufacturing cost plus the estimate of the profit share amount earned by Cardinal. Please explain to us why you exclude the mark-up portion of the inventory in your calculation of cost of sales. Please also explain to us and clarify in the filing what happens in your financial statements if the mark-up is different than your estimate of the profit share amount earned by Cardinal.

37. We note from your disclosure that there are several factors you consider in determining the estimated profit share. Disclose the amount of the estimate recorded in your financial statements and the effect that could result from using other reasonably likely assumptions than what you used to arrive at each accrual such as a range of reasonably likely amounts or other type of sensitivity analysis.

Results of Operations, page 33

38. Please disclose here and in the Business section the reasons you discontinued your AlleRx and Aquatab product lines in February and August 2004.

Liquidity and Capital Resources, page 37

39. We note you have yet to fill in the blank indicating the number of years your current cash and cash equivalents together with the proceeds from this offering will last. Notwithstanding your determination of this figure, please indicate if you expect to raise additional funds in the next 24 months. If you are unable to determine whether you will or not, please disclose the reasons.

Commitments and Contractual Obligations, page 39

40. We note your development or license agreements with PD, JMED, and Cornerstone. Please describe the material provisions of these agreements in the Business section. Your discussion should include:

* All material rights and obligations of the parties to the agreement; * Duration of the agreement; * Quantification of all payments made to date and aggregate potential payments; * Termination provisions, including consequences of early termination; and * Any other terms that may be considered material.

We note you have not filed these agreements as exhibits. Please provide a supplemental analysis supporting your determination that the agreements are not required to be filed or file the agreements. If you have determined that your business is not substantially dependent of these agreements, your analysis should provide a discussion of the facts supporting this determination.

41. We note you paid JMED $2 million in conjunction with the assignment of the AllRx license agreement to Cornerstone. Did you receive anything in exchange for this assignment?

Market, Ranking and Other Data, page 42

42. Please delete the last par

Show Raw Text
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>

Via Facsimile and U.S. Mail
Mail Stop 03-09

							April 22, 2005

Walter E. Riehemann
Vice President & General Counsel
Adams Laboratories, Inc.
425 Main Street
Chester, New Jersey 07930

Re:	Adams Laboratories, Inc.
	Registration Statement on Form S-1
	Filed March 25, 2005
      File Number 333-123585

Dear Mr. Riehemann:

	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.

FORM S-1

General

1. We note your graphic following the cover page of the
prospectus.
Please provide us with proofs of all graphic, visual, or
photographic
information you will provide in the printed prospectus prior to
its
use.  Please note we may have comments regarding any additional
graphics or visuals you may include.

2. Please note that when you file a pre-effective amendment
containing pricing-related information, we may have additional
comments.  As you are likely aware, you must file this amendment
prior to circulating the prospectus.

3. Please note that when you file a pre-effective amendment that
includes your price range, it must be bona fide.  We interpret
this
to mean that your range may not exceed $2 if you price below $20
and
10% if you price above $20.

4. Please note that where we provide examples to illustrate what
we
mean by our comments, they are examples and not complete lists.
If
our comments are applicable to portions of the filing that we have
not cited as examples, please make the appropriate changes in
accordance with our comments.

5. We note that you have requested confidential treatment for
several
of your exhibits under Rule 406 of the Securities Act; we will
furnish comments for your request under separate cover.  Please be
advised, we will not act on any request for acceleration of
effectiveness until we have cleared comments on your request for
confidential treatment.

6. Please provide a substitute for or explain the term "BID" in
the
graphic immediately preceding the back cover page of the
prospectus.

7. We note your statement in the graphic, "[t]he ONLY BID bi-layer
tablet to enhance patient compliance."  Supplementally, please
explain why Mucinex enhances patient compliance.

Prospectus Summary, page 1

8. As you have chosen to include a summary of your strategy,
please
balance this discussion by including a discussion of the risks and
obstacles you must address in implementing this strategy.  This
discussion should be at least as prominent as the discussion of
your
strategy.

9. Please provide a brief discussion of the FDA`s policy of
removing
unapproved competing products from the market once a similar
product
has been approved.  The discussion should address why the
competitors
were permitted to sell unapproved drugs and whether the
determinative
factor was the FDA approval or that your products are sold over
the
counter and the competing products were available by prescription
only.

10. We note your statement, "our current products and products in
development or being considered for development will compete in
many
of the segments included in this combined OTC and prescription
market
that totals approximately $3.9 billion."  You should only include
the
size of your potential target market in which you will compete.
Please confirm the $3.9 billion accurately reflects your target
market or revise accordingly.

11. Please revise to disclose that Cardinal Health is not
currently
meeting your manufacturing requirements.

12. In the summary and throughout your filing you reference
reports
relating to the size of the industry, and your position within the
industry.  Please provide us with supplemental copies of these
reports.  These reports should be marked to indicate the
supporting
information.

Risk Factors
13. Please include a separate stand alone risk factor to disclose
any
known side effects of Mucinex SE and Mucinex DM.

We depend heavily on the success of our existing products ...,
page 7

14. Many of the bullet points included in this risk factor are
discussed as separate stand alone risks.  Please revise to
eliminate
the redundancy by deleting the bullet points that are discussed
more
fully in the risk factor section.  Similarly, revise "We may not
be
successful in our efforts to expand our portfolio of Products."

We do not have our own manufacturing capability and rely on
Cardinal
Health ..., page 7

15. Please revise your heading to disclose that recently Cardinal
Health has not been able to manufacture sufficient quantities of
your
product meet your demand.

16. Please revise your disclosure to indicate you may never find
another suitable source of supply that meets your needs to
manufacture the Mucinex SE or Mucinex DM.

We and Cardinal Health depend on a single supplier for
guaifenesin,
the active ..., page 8
17. If obtaining needed supplies has ever caused a material delay
or
disruption to your business, please discuss.

18. Please identify the circumstances that would allow Boehringer
Ingelheim to raise its prices.

19. Are there any provisions in your agreement with Cardinal
Health
that would allow you to obtain inventory from another source.  If
the
agreement does not contain such provisions, please disclose this
information here.  If the agreement does contain such provisions,
please provide a description of these provisions in the
appropriate
location in your Business section.

20. We note that Cardinal Health`s agreement with Boehringer
Ingelheim allows Cardinal Health the limited ability to enter into
agreements with other parties.  Please briefly describe the
limitations.

We face substantial competition that may prevent us from
maintaining
or increasing ..., page 10
21. To the extent easily obtainable, please disclose your
competitors` share of the target market.

Product liability lawsuits could divert our resources, result in
substantial liability ..., page 11
22. Please disclose the amount of your insurance coverage, or in
the
alternative, please indicate if you believe such coverage amount
is
reasonably adequate to insulate you from potential product
liability
claims.

If we fail to obtain an adequate level of reimbursement for our
products ..., page 12

23. Please revise your heading to disclose that many states do not
cover the costs of your products.

We depend on our key personnel and if we are not able to retain
...,
page 16

24. To the extent known, please disclose the projected time frame
of
your hiring the additional technical personnel.
25. If you have had problems attracting or retaining qualified
employees, please revise to describe the problems you have
experienced.  Additionally, if any key employee has plans to
retire
or leave your company in the near future, please revise the
discussion to disclose this information.

We may undertake strategic acquisitions of technologies and
products.
Integration ..., page 16
26. Please revise your risk factor to disclose that you may not
have
the necessary funds or resources to complete acquisitions.  You
should also highlight your lack of experience in identifying and
completing acquisitions.

If we are unable to protect the intellectual property rights
related
..., page 17

27. Please revise to disclose, even an unsuccessful infringement
action against you may be expensive to defend.

If we are unable to protect the confidentiality of our trade
secrets
..., page 18
28. If your business has been materially and adversely affected by
the disclosure of proprietary information, please discuss the
situation and its consequences.

Legal proceedings or third party claims of intellectual property
...,
page 18

29. To the extent you are aware of any intellectual proprietary
rights that are being infringed upon or that you have been
notified a
third party`s belief that you are infringing on their patent(s),
please revise to disclose the situation and potential
consequences.

An active trading market for our common stock may not develop,
page
20

30. Please revise the statement that you expect your common stock
to
be approved for quotation on the Nasdaq National Market to state
that
you have applied for quotation or intend to apply for quotation as
opposed to stating that you expect to be approved.

We will incur increased costs as a result of being a public
company
and our ..., page 21
31. As currently written, this risk factor discussion could apply
to
any issuer that is becoming a reporting company.  See Item 503(c)
of
Regulation S-K.  Please revise to tailor the discussion to your
company.  For example, you could provide an estimate of the
increase
in expenses related to being a public company, discuss any
difficulties you have encountered in attracting directors, etc.

Use of Proceeds, page 34

32. Please disclose the approximate amount and timing of the
proceeds
you plan to use for the purposes you list in this section.  We
note
you plan to use some proceeds for continued branding of Mucinex.
Please disclose the specific amounts from your offering proceeds
that
you intend to allocate for such purpose.  Additionally, please
specify how much you anticipate spending for product development,
which products you expect to develop using these proceeds and
indicate where in the drug development process you expect to be
after
the expenditure of these proceeds.

33. Please identify with more specificity the uses that you
currently
categorize as "general corporate purposes," and state how much of
the
proceeds you plan to put toward each such use.

Management`s Discussion and Analysis of Financial Condition and
Results of Operations

Critical Accounting Policies and Estimates

Sales Returns and Allowances, pages 30 - 31

34. We believe that your disclosure related to estimates that
reduce
gross revenue such as product returns, cash discounts, rebates
chargebacks, and sale incentives could be improved as follows:
a)	Disclose the nature and amount of each accrual at the balance
sheet date and the effect that could result from using other
reasonably likely assumptions than what you used to arrive at each
accrual such as a range of reasonably likely amounts or other type
of
sensitivity analysis.
b)	We note that you have disclosed the factors you consider in
establishing your product returns and other sales allowances.  To
the
extent that information you consider is quantifiable, disclose
both
quantitative and qualitative information and discuss to what
extent
information is from external sources (e.g., end-customer
prescription
demand, third-party market research data comparing wholesaler
inventory levels to end-customer demand). For example, in
discussing
your estimate of product that may be returned, consider disclosing
and discussing, preferably by product and in tabular format, the
total amount of product (in sales dollars) that could potentially
be
returned as of the balance sheet date and disaggregated by
expiration
period.
c)	If applicable, discuss any shipments made as a result of
incentives and/or in excess of your customer`s ordinary course of
business inventory level.  Discuss your revenue recognition policy
for such shipments.
d)	You should consider disclosing a roll forward of the accrual
for
each estimate for each period presented showing the following:
?	Beginning balance,
?	Current provision related to sales made in current period,
?	Current provision related to sales made in prior periods,
?	Actual returns or credits in current period related to sales
made in current period,
?	Actual returns or credits in current period related to sales
made in prior periods, and
?	Ending balance.

e) In your discussion of results of operations for the period to
period revenue comparisons, discuss the amount of and reason for
fluctuations for each type of reduction of gross revenue, such as
product returns, chargebacks, customer rebates and other discounts
and allowances, including the effect that changes in your
estimates
of these items had on your revenues and operations.

Cardinal Health Profit Share, page 31

35. We note from your disclosure that direct manufacturing cost
plus
the mark-up are merely provided for interim billing purposes.
This
would seem to infer that that the actual cost of the inventory
purchased from Cardinal is the percentage of the profit that
Cardinal
receives.  Please explain to us and cite the authoritative
guidance
used under US GAAP why the inventory is recorded as the direct
manufacturing cost plus the mark-up.

36. Based on your disclosure, cost of sales represents the direct
manufacturing cost plus the estimate of the profit share amount
earned by Cardinal.  Please explain to us why you exclude the
mark-up
portion of the inventory in your calculation of cost of sales.
Please also explain to us and clarify in the filing what happens
in
your financial statements if the mark-up is different than your
estimate of the profit share amount earned by Cardinal.

37. We note from your disclosure that there are several factors
you
consider in determining the estimated profit share.   Disclose the
amount of the estimate recorded in your financial statements and
the
effect that could result from using other reasonably likely
assumptions than what you used to arrive at each accrual such as a
range of reasonably likely amounts or other type of sensitivity
analysis.

Results of Operations, page 33

38. Please disclose here and in the Business section the reasons
you
discontinued your AlleRx and Aquatab product lines in February
2005
and August 2004.

Liquidity and Capital Resources, page 37

39. We note you have yet to fill in the blank indicating the
number
of years your current cash and cash equivalents together with the
proceeds from this offering will last.  Notwithstanding your
determination of this figure, please indicate if you expect to
raise
additional funds in the next 24 months.  If you are unable to
determine whether you will or not, please disclose the reasons.

Commitments and Contractual Obligations, page 39

40. We note your development or license agreements with PD, JMED,
and
Cornerstone.  Please describe the material provisions of these
agreements in the Business section.  Your discussion should
include:

* All material rights and obligations of the parties to the
agreement;
* Duration of the agreement;
* Quantification of all payments made to date and aggregate
potential
payments;
* Termination provisions, including consequences of early
termination; and
* Any other terms that may be considered material.

 	We note you have not filed these agreements as exhibits.
Please
provide a supplemental analysis supporting your determination that
the agreements are not required to be filed or file the
agreements.
If you have determined that your business is not substantially
dependent of these agreements, your analysis should provide a
discussion of the facts supporting this determination.

41. We note you paid JMED $2 million in conjunction with the
assignment of the AllRx license agreement to Cornerstone.  Did you
receive anything in exchange for this assignment?

Market, Ranking and Other Data, page 42

42. Please delete the last par