SEC Company Response from IMMUNOMEDICS INC (CIK 0000722830) — Jul 12, 2005
IMMUNOMEDICS INC (CIK 0000722830)
Date: July 12, 2005 · CIK: 0000722830 · Accession: 0000914121-05-001319
AI Filing Summary & Sentiment
File numbers found in text: 000-12104
Referenced dates: April 24, 2002, April 4, 2002, June 28, 2005, May 8, 2002
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[Immunomedics, Inc. Letterhead]
July 12, 2005
Mr. Jim B. Rosenberg
Senior Assistant Chief Accountant
United States Securities and Exchange Commission
Division of Corporation Finance
Washington, D.C. 20549
Re: Immunomedics, Inc.
Form 10-K for the Fiscal Year Ended June 30, 2004
Filed September 9, 2004
File No. 000-12104
Dear Mr. Rosenberg:
Immunomedics, Inc., a Delaware corporation, ("Immunomedics", "we" or the
"Company") hereby submits this letter in response to comments contained in the
letter dated June 28, 2005, (the "Letter") from Mr. Jim Rosenberg, Senior
Assistant Chief Accountant, of the Staff (the "Staff") of the Securities and
Exchange Commission (the "Commission") to the undersigned.
This response is being effected by direct transmission to the Commission's
EDGAR system. In consultation with our legal and accounting advisors, the
Company has prepared the following responses to the questions and comments
raised by the Staff. For your convenience, we have set forth below in italics
your numbered comments in their entirety followed by the responses thereto.
Item 7. - Management's Discussion and Analysis of Financial Condition and ...,
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page 29
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Research and Development, page 30
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1. Please detail for us how the disclosures about your research and
development projects are consistent with: (a) the specific disclosures
that we had requested in comment #2 of our comment letter dated April 24,
2002 and (b) the specific disclosures that you had proposed in response to
this comment in your letter dated May 8, 2002. Regarding (b), please
provide us with the disclosures that you had proposed in conjunction with
that response, but that you did not appear to include in the response
submitted via EDGAR.
In addition, as you do not track expenses on the basis of each individual
compound under investigation, please tell us how you manage, budget, or
group the projects under development and why management does not maintain
and evaluate research and
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Mr. Jim B. Rosenberg
July 12, 2005
Page 2
development costs by project. In this regard, please provide us other
quantitative or qualitative disclosure that indicates the amount of
resources being used on each project.
Furthermore, please tell us 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.
Response
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In response to the Staff's comment, the Company has carefully reviewed the
requested disclosures set forth in Item #2 of the Commission's letter dated
April 4, 2002 (the "2002 Letter"), the Company's prior response thereto dated
May 8, 2002 and our recent filings with the Commission. The Company plans to
further revise its disclosures related to its research and development
activities as more fully described below. Regarding the specific disclosures in
response to the 2002 Letter, the Company filed a supplemental response letter,
(please see attached for your convenience) that set forth the specific
disclosures the Company believed were necessary to address the Staff's comment.
Since that time, the Company's filings have been consistent with the
supplemental response filed with the Staff.
Historically, the Company has had as many as nine early stage product
candidates in early phase clinical trials, none of which has individually been
financially material from a budgeting and expenditure perspective and all of
which were substantially related. However, the Company has very recently changed
its research and development strategy to focus its efforts only on three
clinical trial programs, with the majority of that focus on the Company's most
advanced program with its lead product candidate epratuzumab. The Company
intends to provide additional detail in its future disclosure with respect to
the costs incurred to date and future costs projected for each late stage trial,
the current status and estimated completion date of each late stage trial, the
risks and uncertainties that may affect the completion of each such trial and
the consequences that such risks and uncertainties may cause. In the event that
any of the aforementioned items is not known or able to be disclosed, the
Company intends to disclose in its future filings that such items are not able
to be included and the reason for any such omissions.
In addition, the Company plans to further enhance its disclosure for
research and development expenses incurred in the Management's Discussion and
Analysis section and the footnotes to its financial statements in the format set
forth below.
Year Ended June 30,
2005* 2004 2003
-----------------------------------
Research $ 7,071 $ 6,213 $ 5,425
Product Development 18,774 15,721 12,750
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Total $25,845 $21,934 $18,175
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Mr. Jim B. Rosenberg
July 12, 2005
Page 3
* Estimates used for presentation purposes, do not reflect actual year-end
balances.
The Company plans to provide a quantitative and qualitative description of
each departmental cost within each research and product development cost below
the table.
As currently disclosed in its filings, the Company does not track expenses
on the basis of each individual compound under investigation. Management
evaluates projects under development from an operational perspective, including
such factors as results of individual compounds from laboratory/animal testing,
patient results and enrollment statistics in clinical trials. It is important to
note that multiple product candidates are often tested simultaneously; for
example, an ELISA assay (a sensitive test used for antibody-antigen detection),
may test multiple antibodies on the same test plate. It is not possible to
calculate each antibody's supply costs. Similar to the ELISA test, there are
many different development processes and test methods that examine multiple
products at the same time.
From the Company's financial perspective, research and development costs
are budgeted for and tracked on a departmental basis. Our research costs
consists of outside costs associated with animal studies and costs associated
with research and testing of our product candidates prior to reaching the
preclinical stage. Such research costs primarily include personnel costs,
facilities, including depreciation; lab supplies, funding of outside contracted
research and license fees. Our product development costs consist of costs from
preclinical development (including manufacturing), conducting and administering
clinical trials and patent expenses.
In response to the Staff's comment regarding amount or range of estimated
costs and timing to complete the phase in process and each future phase of our
research and development projects, the Company notes that it is extremely
difficult to estimate the completion costs for each major research and
development project. However, we plan to include the following disclosure in our
discussion of research and development expenses in the Management's Discussion
and Analysis section of our future filings.
"Completion of clinical trials may take several years or more. The length
of time varies according to the type, complexity and the disease indication of
the product candidate. We estimate that clinical trials of the type we generally
conduct are typically completed over the following periods:
Clinical Phase Estimated Completion Period
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Phase I 1-2 Years
Phase II 1-3 Years
Phase III 2-5 Years
The duration and cost of clinical trials may vary significantly over the
life of a particular project as a result of, among other things, the
following factors:
o the length of time required to recruit qualified patients for clinical
trials;
o the duration of patient follow-up in light of trial results;
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Mr. Jim B. Rosenberg
July 12, 2005
Page 4
o the number of clinical sites required for trials; and
o the number of patients that ultimately participate."
Item 9A - Controls and Procedures, page 69
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2. We note that your principal executive and principal financial officers
concluded that your "disclosure controls and procedures were adequate and
effective to ensure that material information relating to [you] was made
known to them by others within those entities, particularly during the
period in which this Annual Report on Form 10-K was being prepared."
Please tell us how this disclosure complies with Item 307 of Regulation
S-K, as: (a) the definition of disclosure controls and procedures, in
Exchange Act Rule 13a-15, would appear to encompass more than just
ensuring material information was made known to them and (b) Item 307
appears to indicate that the evaluation should have been as of the end of
the period covered by the Annual Report, not the period it was prepared.
Response
--------
In response to the Staff's comment, we will revise this portion of Item 9A
in our future filings as follows:
"We maintain controls and procedures designed to ensure that we are
able to collect the information we are required to disclose in the reports
we file with the SEC, and to record, process, summarize and disclose this
information within the time periods specified in the rules promulgated by
the SEC. Our Chief Executive and Chief Financial Officers are responsible
for establishing and maintaining these disclosure controls and procedures
and, as required by the rules of the SEC, to evaluate their effectiveness.
Based on their evaluation of our disclosure controls and procedures as of
the end of the period covered by this Annual Report on Form 10-K, our
Chief Executive and Chief Financial Officers believe that these procedures
are effective to ensure that we are able to collect, process and disclose
the information we are required to disclose in the reports we file with
the SEC within the required time periods."
While the Company believes that the foregoing was implicit and intended in
its earlier disclosure, we intend to make the foregoing change to our future
filings to clarify our disclosure regarding our disclosure controls and
procedures.
<PAGE>
Mr. Jim B. Rosenberg
July 12, 2005
Page 5
Form 10-Q for the Quarterly Period Ended March 31, 2005
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Part I - Item 2. Management's Discussion and Analysis of Financial Condition
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..., page 6
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Results of Operations, page 20
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Nine-Month Period Ended March 31, 2005 Compared to 2004, page 21
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Litigation Settlement, page 12
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3. Please tell us if and when you received the undisclosed settlement amount,
how you have accounted for and presented it, and whether it is material to
either your liquidity, financial position, or results of operations. If
the undisclosed settlement amount is material, please explain why the
amount is not required to be disclosed by either Items 303(a)(1) or (3) of
Regulation S-K or Financial Reporting codification Section 501.04.
In response to the Staff's comment, the Company received the undisclosed
settlement amount on October 4, 2004. The settlement amount was accounted for as
a component of the change in estimate as described below.
The Company had been accruing legal fees for the Cytogen, Inc. and C.R.
Bard litigation, as the Company intended to proceed to trial to resolve the
matter. Accordingly, most of the $1,111,750 recorded in the Company's financial
statements as a litigation settlement gain represents the reversal of accrued
legal fees, rather than the actual settlement amount.
Upon the settlement of the suit and the settlement of the Company's legal
fees, the Company reversed its earlier accrual and recorded in earnings a
litigation settlement gain in the amount of $1,111,750. The litigation
settlement gain is comprised of three components: (i) the reversal of accrued
legal fees and potential settlement amount, (ii)the actual negotiated legal fee
paid to Foley & Lardner for the litigation settlement, and (iii) the actual
settlement amount paid by Cytogen, Inc. and C.R. Bard. While the amount of the
cash settlement paid to the Company cannot be disclosed in accordance with the
settlement agreement among the parties, the Company is of the opinion that the
cash settlement amount is not material to its liquidity, financial position or
results of operations after considering both quantitative and qualitative
factors. Quantitatively, the settlement amount is less than 0.5% of total assets
at September 30, 2004, less than 1.0% of net equity at September 30, 2004, and
less than 0.9% of the Company's loss from operations for the year ended June 30,
2004. Qualitatively, the Company believes that the net impact of the settlement
was adequately disclosed in its filings and, since liquidity is a key measure
for its stockholders, the net "gain" associated with the settlement was the most
important factor for its stockholders.
Finally, the Company considered disclosing the change in estimate in
general and administrative expenses, however, we felt that such a large credit
in its general and administrative account would improperly distort the trends
and the current year balance. As
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Mr. Jim B. Rosenberg
July 12, 2005
Page 6
such, we determined that separately classifying the settlement was the most
appropriate presentation.
The Company hereby acknowledges that (i) the Company is responsible for
the adequacy and accuracy of the disclosure in the filing; (ii) Staff comments
or changes to disclosure in response to Staff comments do not foreclose the
Commission from taking any action with respect to the filing; and (iii) 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.
Please feel free to contact the undersigned at 973-605-8200 (ex. 185)
should you have any questions regarding the responses herein provided.
Sincerely,
/s/ Gerard G. Gorman
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Gerard G. Gorman
Vice President, Finance and
Chief Financial Officer
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ATTACHMENT
2002 CONFIDENTIAL SUPPLEMENTAL RESPONSE OF IMMUNOMEDICS, INC.
Response No. 1
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