DURA PHARMACEUTICALS INC/CA
S-1MEF, 1997-12-16
PHARMACEUTICAL PREPARATIONS
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<PAGE>
   AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON DECEMBER 16, 1997
 
                                                     REGISTRATION NO. 333-
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
                       SECURITIES AND EXCHANGE COMMISSION
                             WASHINGTON, D.C. 20549
                            ------------------------
                                    FORM S-1
                             REGISTRATION STATEMENT
                                     UNDER
                           THE SECURITIES ACT OF 1933
                            ------------------------
                    SPIROS DEVELOPMENT CORPORATION II, INC.
 
             (Exact name of registrant as specified in its charter)
 
<TABLE>
<S>                              <C>                            <C>
           DELAWARE                          5122                  33-0774288
 (State or other jurisdiction    (Primary Standard Industrial   (I.R.S. Employer
              of                 Classification Code Number)    IdentificationNumber)
incorporation or organization)
</TABLE>
 
        7475 LUSK BOULEVARD, SAN DIEGO, CALIFORNIA 92121 (415) 457-2553
         (Address, including zip code, and telephone number, including
            area code, of registrant's principal executive offices)
                            ------------------------
                                    FORM S-3
                             REGISTRATION STATEMENT
                                     UNDER
                           THE SECURITIES ACT OF 1933
                            ------------------------
                           DURA PHARMACEUTICALS, INC.
             (Exact name of registrant as specified in its charter)
 
<TABLE>
<S>                              <C>                            <C>
           DELAWARE                          5122                  95-3645543
 (State or other jurisdiction    (Primary Standard Industrial   (I.R.S. Employer
              of                 Classification Code Number)     Identification
incorporation or organization)                                      Number)
</TABLE>
 
        7475 LUSK BOULEVARD, SAN DIEGO, CALIFORNIA 92121 (415) 457-2553
         (Address, including zip code, and telephone number, including
            area code, of registrant's principal executive offices)
 
            CAM L. GARNER                           DAVID S. KABAKOFF
    Chairman, President and Chief             Chairman, President and Chief
          Executive Officer                         Executive Officer
      DURA PHARMACEUTICALS, INC.            SPIROS DEVELOPMENT CORPORATION II,
                                                           INC.
         7475 Lusk Boulevard                  c/o Dura Pharmaceuticals, Inc.
     San Diego, California 92121                   7475 Lusk Boulevard
            (619) 457-2553                     San Diego, California 92121
                                                      (619) 457-2553
 (Name, address, including zip code,       (Name, address, including zip code,
            and telephone                             and telephone
number, including area code, of agent     number, including area code, of agent
             for service)                              for service)
 
                            ------------------------
 
                                WITH COPIES TO:
 
        FAYE H. RUSSELL, ESQ.                       MARK KESSELL, ESQ.
   BROBECK, PHLEGER & HARRISON LLP                  SHERMAN & STERLING
    550 West"C" Street, Suite 1300                 599 Lexington Avenue
     San Diego, California 92101                 New York, New York 10022
            (619) 234-1966                            (212) 848-4000
 
                            ------------------------
 
        APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC:
  AS SOON AS PRACTICABLE AFTER THIS REGISTRATION STATEMENT BECOMES EFFECTIVE.
                            ------------------------
 
    If any of the securities being registered on this form are to be offered on
a delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, check the following box: / /
 
    If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the following box
and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering: /X/ 333-37673/37673-01
 
    If this Form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. / /
 
    If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box: / /
 
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
<PAGE>
                        CALCULATION OF REGISTRATION FEE
 
<TABLE>
<CAPTION>
                                                                                           PROPOSED
                                                                       PROPOSED            MAXIMUM
                                                    AMOUNT             MAXIMUM            AGGREGATE           AMOUNT OF
           TITLE OF EACH CLASS OF                   TO BE           OFFERING PRICE         OFFERING          REGISTRATION
        SECURITIES TO BE REGISTERED               REGISTERED           PER UNIT            PRICE(1)              FEE
Units, each consisting of one share of
 Spiros Development Corporation II,[nb]Inc.
 Callable Common Stock, par value $.001 per
 share, and one warrant to purchase one-
 fourth of one share of Dura Common Stock...       934,375              $16.00           $14,950,000            $4,411
<S>                                           <C>                 <C>                 <C>                 <C>
Spiros Development Corporation II, Inc.
 Callable Common Stock included in the
 Units......................................       934,375                --                  --                  --
Dura Common Stock Purchase Warrants included
 in the Units...............................       934,375                --                  --                  --
Dura Common Stock issuable upon exercise of
 the Purchase Option(2).....................         (3)                 (3)             $27,479,969            $8,107
Dura Common Stock issuable upon exercise of
 Dura Common Stock Purchase Warrants
 included in the Units(4)...................       233,594            $44.94(4)          $10,497,714            $3,097
    Total...................................                                             $52,927,683           $15,615
</TABLE>
 
(1) Assumes the exercise of the Underwriters' over-allotment option.
 
(2) Shares to be issued if Dura exercises the Purchase Option described in the
    Prospectus contained herein at any time before January 1, 2001 and pays the
    exercise price in shares of Dura Common Stock.
 
(3) Omitted pursuant to Rule 457(o) under the Securities Act of 1933, as
    amended.
 
(4) Pursuant to Rule 457(g)(3) under the Securities Act of 1933, as amended,
    based on the offering price of securities of the same class as determined in
    accordance with Rule 457(c) under the Securities Act of 1933, as amended.
<PAGE>
               INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
 
    This Registration Statement filed under the Securities Act of 1933, as
amended, by Spiros Development Corporation II, Inc. ("SDC II") and Dura
Pharmaceuticals, Inc. ("Dura") with the Securities and Exchange Commission (the
"Commission") hereby incorporate by reference the contents of the Registration
Statement on Forms S-1/S-3 (File Nos. 333-37673/37673-01) relating to the
offering of an aggregate amount of $101,200,000 of Units by SDC II and Dura.
 
                                 CERTIFICATION
 
    SDC II and Dura hereby certify to the Commission that they have instructed
their bank to pay the Commission the filing fee of $15,615 for the additional
securities being registered hereby as soon as practicable (but in any event no
later than the close of business on December 17, 1997); that it will not revoke
such instructions; that it has sufficient funds in the relevant account to cover
the amount of the filing fee; and that it undertakes to confirm receipt of such
instructions by the bank on December 17, 1997.
<PAGE>
                                   SIGNATURES
 
    Pursuant to the requirements of the Securities Act of 1933, Spiros
Development Corporation II, Inc. has duly caused this Registration Statement to
be signed on its behalf by the undersigned, thereunto duly authorized, in the
City of San Diego, County of San Diego, State of California, on the 16th day of
December, 1997.
 
<TABLE>
<S>                             <C>  <C>
                                SPIROS DEVELOPMENT CORPORATION II, INC.
 
                                By:            /s/ DAVID S. KABAKOFF
                                     ------------------------------------------
                                                 David S. Kabakoff
                                              CHAIRMAN, PRESIDENT AND
                                              CHIEF EXECUTIVE OFFICER
</TABLE>
 
    Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed below by the following persons in the
capacities and on the dates indicated.
 
             NAME                         TITLE                    DATE
- ------------------------------  --------------------------  -------------------
 
                                Chairman, President and
    /s/ DAVID S. KABAKOFF         Chief Executive Officer
- ------------------------------    (Principal Executive       December 16, 1997
     (David S. Kabakoff)          Officer)
 
                                Vice President and Chief
              *                   Financial Officer
- ------------------------------    (Principal Financial and   December 16, 1997
        (Erle T. Mast)            Accounting Officer)
 
              *
- ------------------------------  Director                     December 16, 1997
       (Cam L. Garner)
 
*By:    /s/ DAVID S. KABAKOFF
      -------------------------
          David S. Kabakoff
         David S. Kabakoff,
          ATTORNEY-IN-FACT
 
                                      II-1
<PAGE>
                                   SIGNATURES
 
    Pursuant to the requirements of the Securities Act of 1933, Dura
Pharmaceuticals, Inc. certifies that it has reasonable grounds to believe that
it meets all of the requirements for filing on Form S-3 and has duly caused this
Registration Statement to be signed on its behalf by the undersigned, thereunto
duly authorized, in the City of San Diego, County of San Diego, State of
California, on the 16th day of December, 1997.
 
<TABLE>
<S>                             <C>  <C>
                                DURA PHARMACEUTICALS, INC.
 
                                By:              /s/ CAM L. GARNER
                                     -----------------------------------------
                                                   Cam L. Garner
                                              CHAIRMAN, PRESIDENT AND
                                              CHIEF EXECUTIVE OFFICER
</TABLE>
 
    Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed below by the following persons in the
capacities and on the dates indicated.
 
<TABLE>
<CAPTION>
             NAME                         TITLE                    DATE
- ------------------------------  --------------------------  -------------------
 
<C>                             <S>                         <C>
                                Chairman, President and
      /s/ CAM L. GARNER           Chief Executive Officer
- ------------------------------    (Principal Executive       December 16, 1997
       (Cam L. Garner)            Officer)
 
                                Senior Vice President,
                                  Finance and
     /s/ JAMES W. NEWMAN          Administration, and
- ------------------------------    Chief Financial Officer    December 16, 1997
      (James W. Newman)           (Principal Financial and
                                  Accounting Officer)
 
    /s/ DAVID S. KABAKOFF
- ------------------------------  Executive Vice President     December 16, 1997
     (David S. Kabakoff)          and Director
 
                                Senior Vice President,
              *                   Sales and Marketing,
- ------------------------------    Director and Marketing,    December 16, 1997
      (Walter F. Spath)           Director
 
              *
- ------------------------------  Director                     December 16, 1997
       (James C. Blair)
 
              *
- ------------------------------  Director                     December 16, 1997
     (Herbert J. Conrad)
</TABLE>
 
                                      II-2
<PAGE>
<TABLE>
<CAPTION>
             NAME                         TITLE                    DATE
- ------------------------------  --------------------------  -------------------
 
<C>                             <S>                         <C>
              *
- ------------------------------  Director                     December 16, 1997
       (Joseph C. Cook)
 
              *
- ------------------------------  Director                     December 16, 1997
       (David F. Hale)
 
              *
- ------------------------------  Director                     December 16, 1997
     (Gordon V. Ramseier)
 
              *
- ------------------------------  Director                     December 16, 1997
      (Charles G. Smith)
</TABLE>
 
*By:      /s/ CAM L. GARNER
      -------------------------
            Cam L. Garner
           Cam L. Garner,
          ATTORNEY-IN-FACT
 
                                      II-3
<PAGE>
                                 EXHIBIT INDEX
 
<TABLE>
<CAPTION>
  EXHIBIT
    NO.                                                     DESCRIPTION
- -----------  ---------------------------------------------------------------------------------------------------------
<C>          <S>
       5.1   Opinion of Brobeck, Phleger & Harrison LLP as to the legality of the securities being registered,
               including consent.
 
       8.1   Opinion of Brobeck, Phleger & Harrison LLP as to certain tax matters, including consent.
 
      23.1   Consent of Brobeck, Phleger & Harrison LLP (included in exhibits 5.1 and 8.1).
 
      23.2   Consent of Deloitte & Touche LLP, Independent Auditors.
 
      23.3   Consent of Kleinfeld, Kaplan and Becker.
 
      24.1*  Powers of Attorney.
</TABLE>
 
- ------------------------
 
*   Incorporated by reference to the same-numbered exhibit to the Registration
    Statement on Forms S-1/S-3 (No. 333-37673/37673-01) filed on October 12,
    1997, as amended.

<PAGE>


                                                                  EXHIBIT 5.1


                     [BROBECK, PHLEGER & HARRISON LLP LETTERHEAD]


                                  December 16, 1997


Dura Pharmaceuticals, Inc.
7475 Lusk Boulevard
San Diego, CA 92121

Spiros Development Corporation II, Inc.
7475 Lusk Boulevard
San Diego, CA 92121

    Re:  PUBLIC OFFERING OF UNITS

Ladies and Gentlemen:

         We have acted as counsel to Dura Pharmaceuticals, Inc., a Delaware 
corporation ("Dura"), and Spiros Development Corporation II, Inc., a Delaware 
corporation ("Spiros Corp. II"), in connection with the proposed issuance and 
sale, pursuant to a Registration Statement on Forms S-1/S-3 (the 
"Registration Statement"), of up to 934,375 units (the "Units"), including   
97,500 and 24,375 Units which the U.S. Underwriters and International 
Underwriters, respectively, have the option to purchase to cover 
over-allotments, if any.  Each Unit consists of one share of the callable 
common stock of Spiros Corp. II (the "Callable Common Stock") and one warrant 
to purchase one-fourth of one share of the common stock of Dura (the 
"Warrants"). The Registration Statement relates to (i) the offer and sale of 
the Callable Common Stock, (ii) the offer and sale of the Warrants and the 
shares of Dura common stock underlying the Warrants (the "Warrant Shares") 
and (iii) the shares of Dura common stock issuable, if any, if Dura exercises 
the Purchase Option as described in the Registration Statement and related 
prospectuses (the "Prospectuses") and pays the exercise price in shares of 
Dura common stock (the "Purchase Option Shares").  The Units, the Callable 
Common Stock, the Warrants, the Warrant Shares and the Purchase Option Shares 
are hereinafter collectively referred to as the "Securities." Capitalized 
terms not otherwise defined herein shall have the meanings given to them in 
the Registration Statement.

         This opinion is being furnished in accordance with the requirements of
Item 16(a) of Form S-1, Item 16(a) of Form S-3 and Item 601(b)(5)(i) of
Regulation S-K under the Securities Act of 1933, as amended (the "Act").

         In connection with this opinion, we have examined the Registration
Statement and related Prospectuses; Dura's Amended and Restated Certificate of
Incorporation, as amended through the date hereof; Spiros Corp. II's Certificate
of Incorporation, as amended through the date hereof; the Amended and Restated
Certificate of Incorporation of Spiros 


<PAGE>

Dura Pharmaceuticals, Inc.                                 December 16, 1997
Spiros Development Corporation II, Inc.                               Page 2

Corp. II, which the Registration Statement contemplates will become effective
immediately prior to the issuance and sale of the Units; Dura's Amended and
Restated Bylaws, as amended through the date hereof; Spiros Corp. II's Bylaws,
as amended through the date hereof; the Amended and Restated Bylaws of Spiros
Corp. II, which the Registration Statement contemplates will become effective
immediately prior to the issuance and sale of the Units; and the originals, or
copies certified to our satisfaction, of such records, documents, certificates,
memoranda and other instruments as in our judgment are necessary or appropriate
to enable us to render the opinion expressed below (the "Documents").  We are
relying (without any independent investigation thereof) upon the truth and
accuracy of the statements, covenants, representations and warranties set forth
in such Documents.

         On the basis of the foregoing, and in reliance thereon, we are of 
the opinion that the Securities, if, as and when sold and issued in 
accordance with and in the manner referred to in the Registration Statement 
and Prospectuses (as amended and supplemented through the date of issuance) 
and, in the case of the Warrant Shares or the Purchase Option Shares, when 
issued in compliance with the terms of the respective Warrants or Purchase 
Option, will be validly issued, fully paid and nonassessable. 
 
         We consent to the filing of this opinion as Exhibit 5.1 to the
Registration Statement and to the reference to this firm under the caption
"Legal Matters" in the Prospectuses.  In giving this consent, we do not thereby
admit that we are within the category of persons whose consent is required under
Section 7 of the Act or the rules and regulations of the Securities and Exchange
Commission promulgated thereunder.

         This opinion is expressed as of the date hereof and we disclaim any
undertaking to advise you of any subsequent changes in applicable law or in the
facts stated or assumed herein which may alter, affect or modify the opinion
expressed herein.  Our opinion is expressly limited to the matters set forth
above and we render no opinion, whether by implication or otherwise, as to any
other matters relating to Dura, Spiros Corp. II or the Securities.


                             Very truly yours,

                             /s/ Brobeck, Phleger & Harrison LLP

                             BROBECK, PHLEGER & HARRISON LLP


<PAGE>

                                                                   EXHIBIT 8.1

                               December 16, 1997



Dura Pharmaceuticals, Inc.
7475 Lusk Boulevard
San Diego, California 92121

Spiros Development Corporation II, Inc.
7475 Lusk Boulevard
San Diego, California 92121

Ladies and Gentlemen:

     We have acted as counsel to Dura Pharmaceuticals, Inc., a Delaware 
corporation ("Dura"), and, in certain limited matters, to Spiros Development 
Corporation II, Inc., a Delaware corporation ("Spiros Corp. II"), in 
connection with the offering ("Offering") of units consisting of one share of 
the Callable Common Stock of Spiros Corp. II ("Spiros Corp. II Common Stock") 
and one warrant ("Warrant") to purchase one-fourth of one share of the Common 
Stock of Dura (the "Units"), pursuant to Spiros Corp. II's and Dura's 
Registration Statement on Forms S-1/S-3 (the "Registration Statement").

     In connection with this opinion, we have examined the Registration 
Statement and related Prospectuses, Dura's Amended and Restated Certificate 
of Incorporation, as amended through the date hereof, Dura's bylaws, as 
amended through the date hereof, Spiros Corp. II's Certificate of 
Incorporation (including a copy of the Amended and Restated Certificate of 
Incorporation to be filed by Spiros Corp. II immediately prior to the closing 
of the Subscription Offering), and Spiros Corp. II's bylaws, as amended 
through the date hereof. We have also reviewed the originals, or copies 
certified to our satisfaction, of the Technology License Agreement, the 
Development Agreement, the Manufacturing and Marketing Agreement, the 
Services Agreement, the Albuterol and Product Option Agreement and such other 
agreements (the "Agreements") and such records, documents, certificates, 
memoranda and other instruments as in our judgment are necessary or 
appropriate to enable us to render the opinion expressed below (the 
"Documents"). We are relying (without any independent investigation thereof) 
upon the truth and accuracy of the statements, covenants, representations and 
warranties set forth in the Registration Statement, the Agreements and the 
Documents.

     In rendering the opinions set forth below, we have relied (or will rely) 
upon the following additional representations and assumptions:

<PAGE>

Dura Pharmaceuticals, Inc.                                    December 16, 1997
Spiros Development Corporation II, Inc.                                  Page 2


     1.  The form of Agreements and Documents supplied to us that we reviewed 
         in connection with rendering opinions hereunder will be validly
         executed in substantially the same form in which they have been filed
         as exhibits to the Registration Statement and will be binding and 
         enforceable in accordance with their terms.

     2.  All parties will perform under such Agreements in accordance with 
         their terms.

     3.  There are no other or further agreements which would alter, amend or 
         otherwise materially affect the relationships created by or described
         in the above listed Agreements and Documents or described in the
         Registration Statement.

     Our opinions represent only our best judgment regarding the application 
of federal income tax laws under the Internal Revenue Code of 1986, as 
amended (the "Code"), existing judicial decisions, administrative regulations 
and published rulings and procedures. Our opinion is not binding upon the 
Internal Revenue Service or the courts, and there is no assurance that the 
Internal Revenue Service will not successfully assert contrary positions. 
Furthermore, no assurance can be given that future legislative, judicial 
decisions or administrative changes, applicable either on a prospective or 
retroactive basis, might not materially alter our opinions. Nevertheless, we 
undertake no responsibility to advise you of any new developments in the 
application or interpretation of the federal income tax laws.

     Based on and subject to the foregoing, we are of the opinion that the 
statements in the Registration Statement and the Prospectuses (as amended and 
supplemented through the date of issuance) under the captions "United States 
Federal Income Tax Consequences" and "United States Taxation of Non-U.S. 
Persons," to the extent they constitute matters of law or legal conclusions 
with respect thereto, have been prepared or reviewed by us and are correct in 
all material respects.

     We express no opinion as to any other tax issues affecting persons 
acquiring, holding or disposing of the Units, the Spiros Corp. II Common 
Stock, the Warrants or the Common Stock of Dura issuable upon exercise of the 
Warrants or Dura's Purchase Option (as defined in the Registration Statement) 
or any other party to any of the Agreements, nor does our opinion address 
state, local or foreign tax consequences that may result from the 
transactions.

<PAGE>

Dura Pharmaceuticals, Inc.                                    December 16, 1997
Spiros Development Corporation II, Inc.                                  Page 3


     We consent to the use of this opinion as an exhibit to the Registration 
Statement. 

                                       Respectfully,

                                       /s/ Brobeck, Phleger & Harrison LLP

                                       BROBECK, PHLEGER & HARRISON LLP









<PAGE>

                                                                   EXHIBIT 23.2

                        INDEPENDENT AUDITORS' CONSENT

     We consent to the incorporation by reference in this combined 
Registration Statement of Spiros Development Corporation II, Inc. ("Spiros 
II") on Form S-1 and of Dura Pharmaceuticals, Inc. ("Dura") on Form S-3 
pursuant to Rule 462(b) under the Securities Act of 1933, as amended, 
(collectively, the "Registration Statement") of our report dated January 20, 
1997, relating to the consolidated financial statements of Dura, incorporated 
by reference in the Annual Report on Form 10-K of Dura for the year ended 
December 31, 1996.

     We also consent to the incorporation by reference in this Registration 
Statement of our report dated March 21, 1997 (November 6, 1997 as to Note 7), 
relating to the financial statements of Spiros Development Corporation (a 
development stage enterprise) as of December 31, 1995 and 1996 and for the 
periods then ended appearing in the Current Report of Dura on Form 8-K filed 
on October 10, 1997, as amended. We also consent to the incorporation by 
reference in this Registration Statement of our report dated October 9, 1997, 
relating to the balance sheet of Spiros II (a development stage enterprise) 
as of September 30, 1997.

     We also consent to the references to us under the heading "Experts" in 
the Prospectus, which is part of the combined Registration Statement No. 
333-37673/37673-01 of Spiros II on Form S-1 and Dura on Form S-3, 
incorporated by reference in this Registration Statement.


DELOITTE & TOUCHE LLP


San Diego, California
December 16, 1997


<PAGE>

                                                                EXHIBIT 23.3

                     KLEINFELD, KAPLAN AND BECKER LETTERHEAD 

The undersigned hereby consent to the use of our name and the statement with
respect to us that appears under the heading "Experts" contained in the
Registration Statement on Forms S-1/S-3 and related Prospectus of Spiros
Development Corporation II, Inc. and Dura Pharmaceuticals, Inc.

                                                  KLEINFELD, KAPLAN AND BECKER

                                                  /s/ Richard S. Morey
                                                  ----------------------------
                                                  Richard S. Morey

Dated: December 16, 1997






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