SEC Company Response from ARRAY BIOPHARMA INC (CIK 0001100412) — Jun 16, 2005
ARRAY BIOPHARMA INC (CIK 0001100412)
Date: June 16, 2005 · CIK: 0001100412 · Accession: 0001047469-05-017464
AI Filing Summary & Sentiment
File numbers found in text: 001-16633
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HOGAN & HARTSON L.L.P.
Columbia Square
555 Thirteenth St., N.W.
Washington, D.C. 20004
202/637-5600
June 16,
2005
VIA EDGAR AND BY UNITED PARCEL SERVICE
United
States Securities and Exchange Commission
100 First Street, N.E.
Washington, D.C. 20549
Mail Stop 6010
Attention: Jim B. Rosenberg
Division of Corporate Finance
Re:
Array BioPharma Inc.
Form 10-K for the fiscal year ended June 30, 2004
Form 10-Q for the quarterly period ended March 31, 2005
File No. 001-16633
Ladies
and Gentlemen:
On
behalf of Array BioPharma Inc. (the "Company"), we are responding to the comments of the staff of the Securities and Exchange Commission (the "Staff") transmitted to
Mr. R. Michael Carruthers on May 27, 2005 regarding the above captioned annual report on Form 10-K for the Company's fiscal year ended June 30, 2004 (the
"Form 10-K") and the quarterly report on Form 10-Q for the Company's fiscal quarter ended March 31, 2005 (the "Form 10-Q").
The
Company's responses to the Staff's comments are set forth below, and for ease of reference, we have reproduced your comments followed by the Company's response. Unless otherwise
indicated, all references to page numbers in the responses below refer to page numbers in the Form 10-K and the Form 10-Q, as applicable.
As
discussed below, the Company believes that a number of the changes suggested by the Staff's comments can enhance the Company's disclosure, and therefore the Company intends to
incorporate those suggestions in its annual report on Form 10-K for the fiscal year ended June 30, 2005 (the "Fiscal 2005 Form 10-K"), which the Company
intends to file no later than August 31, 2005. The Company does not believe that the changes the Company intends to make, individually or in the aggregate, are material to an investor's
investment decision or would be material if also incorporated in amendments to the Form 10-K or the subsequently filed quarterly reports. In many cases, the additional information
the Company would include can be derived from other information already provided in the Form 10-K and subsequently filed quarterly reports. Amending the prior reports so close in
time to the filing of the Fiscal 2005 Form 10-K would not, therefore, provide any useful or meaningful disclosure to investors.
Once
the Staff has reviewed the responses set forth below, the Company would welcome the opportunity to discuss any additional questions the Staff may have.
*
* * * *
Form 10-K for the fiscal year ended June 30,2004
Item 7. Management's Discussion and Analysis of Financial Condition and Results … page 32
Results of Operations, page 35
1.Where you attribute multiple factors for the changes in your revenues, costs and expenses, please ensure that you have quantified these factors, as required by
Financial Reporting Codification Section 501.04.
Response:
Disclosure of multiple factors contributing to changes in line items of the financial statements is required where the identification and quantification of the
extent of the contribution of each of two or more factors is necessary to an understanding of a material change in a line item in the financial statements. The Company believes that it has provided
information quantifying factors that contribute to material changes for the periods covered by the Form 10-K where such information is material to an understanding of the changes.
The Company notes the Staff's comment, however, and will continue to enhance this disclosure in the Fiscal 2005 Form 10-K and in subsequently filed periodic reports to the extent
necessary to aid investors in understanding material changes in the line items to the Company's financial statements.
2.We noted that it is not expected that Lead Generation Libraries will be a significant source of revenues in future periods and that no new Lead Generation
Libraries will be produced other than for your own proprietary research. Based on this and your other disclosures about your sources of revenues, it would appear that any future revenues would result
almost exclusively from out-license and collaboration agreements or from research funding received from your collaborators. In addition, we noted that you plan to continue to increase your
investment in your proprietary research programs and that you intend to progress these programs through clinical development.
In light of the above, we believe that your disclosures about historical research and development expenses and estimated future expenses related to your major research and
development projects could be enhanced for investors. Please refer to the Division of Corporation Finance "Current Issues and Rulemaking Projects Quarterly Update" under
section VIII—Industry Specific: Issues—Accounting and disclosure by Companies Engaged in Research and Development Activities. You can find it at the following website
address: http://www.sec.gov/divisions/eorpfin/cfcrg032001.htm.
Please expand your MD&A to disclose the following information for each of your major research and development projects:
a.The current status of the project;
b. The costs incurred during each period presented and to date on each project;
c. The nature, timing and estimated costs of the efforts necessary to complete each project;
d. The anticipated completion dates of each project;
e. The risks and uncertainties associated with completing development on schedule, and the consequences to operations, financial position and liquidity if each project
is not completed
timely; and finally
f. The period in which material net cash inflows from significant projects are expected to commence for each project.
Regarding b., if you do not maintain any research and development costs by project, please disclose that fact and explain why management does not maintain and evaluate research
and
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development costs by project. In this regard, please provide other quantitative or qualitative disclosure that indicates the amount of the company's resources being used on the
project.
Regarding c. and d., please 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, please disclose those facts and circumstances indicating the uncertainties that preclude you from making a reasonable estimate.
Response:
The Company agrees that its disclosure regarding the status of its major R&D programs could be improved and will seek to enhance this disclosure in future
filings. The Company has disclosed the nature and status of these programs in the business section of the Form 10-K, and will continue to do so in future filings. The Company will
also include a summary of this information in MD&A in future filings as suggested by the Staff.
The
Company manages its R&D projects based on scientific data, and achievement of research plan goals. The Company's scientists record their time to specific projects when possible. However, many
activities simultaneously benefit multiple projects and cannot be readily attributed to a specific project. Accordingly, accurate assignment of time and costs to a specific project is difficult and
potentially misleading. The Company proposes to further explain the limitations of its project cost accounting in the Fiscal 2005 Form 10-K and in subsequent periodic filings. The
Company does, however, track R&D costs by type. As its R&D costs increase, the Company intends to include in future filings disclosure of types of R&D costs, including salary and benefit costs,
consulting and outsourced services, laboratory supplies and facilities and depreciation, in the Results of Operations section of MD&A.
The
timing and cost of inventing and developing drugs are highly variable and involve many factors over which the Company has limited control or visibility, particularly for drug discovery programs at
an early stage. In addition, the Company is at an early stage for developing drugs and as a result does not have sufficient internal data to accurately project completion dates or total costs. The
Company proposes to clarify this in its subsequent SEC filings and include typical, industry-wide expected completion dates for various development stages and, as it gains specific
experience, supplement this industry information with its own institutional experience in future filings.
As
requested by the Staff, the Company will include in MD&A of future filings additional disclosure of risks and uncertainties associated with the ability of the Company to timely achieve R&D project
goals, at all or within the Company's or its collaborators' expected schedule, as well as the consequences of
not doing so. The Company also notes that this information is currently disclosed in the Form 10-K in the Company's Risk Factors.
Liquidity and Capital Resources; page 38
On page 32, we noted that you have the potential to earn over $200 million in additional milestone payments. So long as you disclose milestone payments that you may
receive, please elaborate on the material uncertainties affecting realization of these payments.
Response:
The Company notes that it has disclosed on page 39 that it may not receive milestone and/or royalty payments under its collaboration agreements, which may impact
its future capital requirements. In addition, the Company has described in its risk factors on page 16 "We have a history of losses and may not achieve or sustain profitability", page 17 "We may not
be successful in entering into additional out-license agreements on favorable terms", page 18 "Our collaborators have substantial control and discretion over the timing and the continued
development and marketing of drug candidates we create", page 19 "The sale and manufacture of drug candidates that we develop with our collaborators or on our own may
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not
receive regulatory approval", and page 21 "If our drug discovery and development programs do not progress as anticipated, our revenue and stock price could be negatively impacted" the material
uncertainties affecting the Company's ability to realize these payments. The Company notes the Staff's comment, however, and intends to include disclosure of these material uncertainties in Liquidity
and Capital Resources beginning with the Fiscal 2005 Form 10-K.
Item 8. Financial Statements and Supplementary Data, page 42
Statements of Operations, page 45
3.As suggested by paragraph 14 of chapter 4 of ARB 43, the provision for excess inventory should be presented as a separate line item in your statement of
operations. It should, however, be within total cost of sales. Please revise your statement of operations presentation and your MD&A discussions of cost of sales and gross margin, accordingly.
Response:
Although paragraph 14 of chapter 4 of ARB 43 suggests that the provision for excess inventory should be within total cost of sales, the Company
respectfully submits that its presentation provides all material information to investors both in the Statement of Operations and in MD&A, is not misleading and assists investors in understanding the
impact of the Company's inventory write down in the affected and comparable periods. As a result, the Company does not believe that an amendment to the Form 10-K is necessary.
Notes to Financial Statements, page 48
1. Business and Summary of Significant Accounting Policies, page 48
4.We noted that you have entered into various research and development agreements but did not note the disclosures required by paragraph 14 of SFAS 68. As
such, please provide the disclosures. Otherwise, please tell us how these agreements are not within the scope of SFAS 68, as defined in paragraph 3, or where you provided these
disclosures.
Response:
The Company's out-licensing and collaboration agreements provide for research funding based on the number of full time equivalent employees
contractually assigned to a program. The Company does not bear any risk of the failure of the contracted research and development activities and the payments are not contingent based on the success or
failure of these activities. SFAS 68 applies to "…research and development arrangements through which [an enterprise] can obtain the results of research and
development funded partially or entirely by others." Accordingly, the Company does not believe these agreements are within the scope of SFAS 68. The Company will review its disclosure beginning
with the Fiscal 2005 Form 10-K to make any enhancements it believes are necessary to clarify this for investors.
Property. Plant and Equipment, page 49
5.We noted that you amortize leasehold improvements over a lease term that appears to assume that you will exercise optional extensions of the lease term. Please
tell us why this lease term is appropriate, as it is defined in paragraph 5(f) of SFAS 13. If the renewals are reasonably assured, as per paragraph 5(f), please disclose this fact
and why they are reasonably assured under "Obligations and Commitments" in MD&A.
Response:
The Company amortizes leasehold improvements over the useful life of the lease, which the Company believes to be 15 years. This period includes one or
more of the several available extension options included in the Company's leases. Because of the high cost to
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create
laboratory space and its relative scarcity, the Company concluded that, as of June 30, 2004, continuing to lease its buildings for at least 15 years was reasonably assured.
The
Company reassesses the usefulness of its leased spaces regularly to determine whether they continue to warrant a useful life of 15 years, and if there is any change, will make appropriate
changes to the disclosures in the Fiscal 2005 Form 10-K.
Software Development Cost, page 50
6.We noted that you capitalize costs incurred on projects intended to create a new software system or to add identifiable functionality to an existing system.
Please tell us the intended uses for this software and whether you have capitalized these costs under SFAS 86 or SOP 98-1. In addition, please tell us how your capitalization of these
costs have complied with that guidance, in terms of the stages during which you capitalized these costs and the types of costs being capitalized,
Response:
The Company capitalizes software development costs as required by SOP 98-1. The Company uses the software it develops in scientific systems for
capturing, searching and presenting data. All direct, payroll-related costs for time incurred during the software development stage is capitalized. However, any time incurred for preliminary project
planning, training, implementation or ongoing maintenance is charged to operations and not capitalized.
Revenue Recognition, page 50
7.We noted your revenue recognition policies and have the following comments:
Response:
The Company's revenue is derived from designing, creating, optimizing and evaluating drug candidates for its collaborators. The majority of the Company's
collaboration revenue consists of fees paid based on contracted hourly rates for full time equivalent employees working on a project. A minority of the Company's revenue is derived from development
and fixed fee revenue, which was approximately $300,000 in fiscal 2004, and similar minor amounts in 2003 and 2002, and per-compound revenue, which was approximately $8 million in
fiscal 2004.
a.Please clarify for us why it is appropriate, under SAB Topic 13.A.3 (SAB 104), to recognize revenue from fees under collaboration agreements on a monthly basis
as work is performed. In so doing, please tell us whether these agreements have any output measures upon which the fees should be recognized as revenue. If not, please clarify why monthly recognition
is consistent with your pattern of performance.
Response:
The revenue generated under the Company's collaboration agreements is largely recognized on a monthly basis for fees paid t