As filed with the Securities and Exchange Commission on July 26, 2023
Registration No. 333-
Delaware | | | 84-1850815 |
(State or other jurisdiction of incorporation or organization) | | | (I.R.S. Employer Identification Number) |
Large accelerated filer | | | ☒ | | | Accelerated filer | | | ☐ |
Non-accelerated filer | | | ☐ | | | Smaller reporting company | | | ☐ |
| | | | Emerging growth company | | | ☐ |
• | the success, cost and timing of our clinical development of our product candidates, including the progress of, and results from, our ongoing Phase 3 clinical trial of acoramidis, our ongoing Phase 2 and planned Phase 3 clinical trials of low-dose infigratinib, our ongoing Phase 2 and planned Phase 3 clinical trials of BBP-418, our ongoing Phase 1/2 clinical trial of BBP-631 and our ongoing Phase 2b and Phase 3 clinical trials of encaleret, as well as the potential indications for each; |
• | our ability to continue planned preclinical and clinical development of our respective development programs, and the timing, cost and success of any such continued preclinical and clinical development and planned regulatory submissions, including our KRAS inhibitor portfolio; |
• | our ability to initiate, recruit and enroll patients in and conduct our clinical trials at the pace that we project; |
• | the timing of our submissions to the U.S. Food and Drug Administration, or FDA, and any review or comments on data that we will need to generate to file our Investigational New Drug applications, or INDs, including pending or new clinical hold notices; |
• | our plans to implement certain development strategies, including our ability to attract and retain potential collaborators with development, regulatory and commercialization expertise; |
• | our ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations or warnings in the label of any of our product candidates, if approved; |
• | our ability to obtain and maintain regulatory approval of our product candidates in any of the indications for which we plan to develop them, and any related restrictions, limitations or warnings in the label of any of our product candidates, if approved; |
• | our ability to compete with companies currently marketing approved treatments or engaged in the development of treatments that may become available for any of the indications that our product candidates are designed to target; |
• | our reliance on third parties to conduct our clinical trials and to manufacture drug substance for use in our clinical trials; |
• | our ability to contract with and the performance of our and our collaborators’ third-party suppliers and manufacturers; |
• | the pricing and reimbursement of our product candidates, if approved; |
• | the size and growth potential of the markets for our product candidates or other product candidates we may identify and pursue, and our ability to serve and gain acceptance by those markets; |
• | our ability to identify and advance through clinical development any additional product candidates, including from our KRAS inhibitor portfolio for the treatment of KRAS-driven cancers; |
• | the commercialization of our current product candidates, if approved, and any other product candidates we may identify and pursue, if approved, including our ability to successfully build a specialty sales force and commercial infrastructure to market our current product candidates and any other product candidates we may identify and pursue; |
• | the implementation and effects of the restructuring initiative that we commenced in January 2022 and any future restructuring plans that we may pursue; |
• | the impacts of the COVID-19 pandemic and macroeconomic factors that could impact our business, such as the effects of the Russian invasion of Ukraine on the global economy and supply chain and inflationary pressures; |
• | our ability to retain and recruit key personnel; |
• | the success of competing therapies that are or may become available; |
• | our ability to obtain and maintain adequate intellectual property rights for our product candidates and our ability to operate our business without infringing on the intellectual property rights of others; |
• | our expectations regarding government and third-party payor coverage and reimbursement; |
• | our estimates of our expenses, ongoing losses, capital requirements and our use of cash resources, and our needs for or ability to pay for debt interests and obtain additional financing to complete the clinical trials of any of our product candidates; |
• | our expectations regarding the use of proceeds from any sales of securities pursuant to this prospectus or any applicable prospectus supplement; |
• | the impact of laws and regulations in the United States and foreign countries; |
• | our financial performance; |
• | developments and projections relating to our competitors or our industry; and |
• | adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults, or non-performance by financial institutions or transactional counterparties. |
| | Shares Beneficially Owned Before this Offering | | | Number of Shares Offered | | | Shares Beneficially Owned After this Offering(4) | |||||||
Name of Selling Stockholder | | | Shares | | | % | | | Shares | | | % | |||
Viking Global Entities(1) | | | 25,120,991 | | | 15.6% | | | 25,120,991 | | | 0 | | | * |
KKR Genetic Disorder L.P.(2) | | | 31,060,971 | | | 19.2% | | | 31,060,971 | | | 0 | | | * |
Aisling Capital IV, LP(3) | | | 6,068,125 | | | 3.8% | | | 6,068,125 | | | 0 | | | * |
* | Less than 1%. |
(1) | Consists of (i) 631,167 shares held by Viking Global Equities Master Ltd. (“VGEM”), (ii) 251,204 shares held by Viking Long Fund Master Ltd. (“VLFM”) and (iii) 24,238,620 shares held by Viking Global Opportunities Illiquid Investments Sub-Master LP (“Opportunities Fund”). VGEM has the power to dispose of and vote the shares directly owned by it, which power may be exercised by its investment manager, Viking Global Performance LLC (“VGP”), and by Viking Global Investors LP (“VGI”), which provides managerial services to VGEM. VLFM has the power to dispose of and vote the shares directly owned by it, which power may be exercised by its investment manager, Viking Long Fund GP LLC (“VLFGP”), and by VGI, which provides managerial services to VLFM. Opportunities Fund has the authority to dispose of and vote the shares directly owned by it, which power may be exercised by its general partner, Viking Global Opportunities Portfolio GP LLC (“Opportunities Portfolio GP”), and by VGI, which provides managerial services to Opportunities Fund. Viking Global Opportunities GP LLC (“Opportunities GP”) serves as the sole member of Opportunities Portfolio GP and has the power to direct the vote and disposition of investments held by Opportunities Portfolio GP, which consists of the investments held by Opportunities Fund. Viking Global Opportunities Parent GP LLC (“Opportunities Parent,” and together with all of the preceding entities, the “Viking Global Entities”) serves as the sole member of Opportunities GP and has the power to direct the vote and disposition of investments held by Opportunities GP, which consists of the investments held by Opportunities Portfolio GP, which consists of the investments held by Opportunities Fund. O. Andreas Halvorsen, David C. Ott and Rose Shabet, as Executive Committee Members of Viking Global Partners LLC (the general partner of VGI), VGP, VLFGP and Opportunities Parent have shared authority to dispose of and vote the shares of beneficially owned by VGI, VGP, VLFGP and Opportunities Parent. The business address of each of the Viking Global Entities is 55 Railroad Avenue, Greenwich, Connecticut 06830. |
(2) | Consists of 31,060,971 shares of common stock directly owned by KKR Genetic Disorder L.P. KKR Genetic Disorder GP LLC, as the general partner of KKR Genetic Disorder L.P., KKR Group Partnership L.P., as the sole member of KKR Genetic Disorder GP LLC, KKR Group Holdings Corp., as the general partner of KKR Group Partnership L.P., KKR Group Co. Inc., as the sole stockholder of KKR Group Holdings Corp., KKR & Co. Inc., as the sole stockholder of KKR Group Co. Inc., KKR Management LLP, as the Series I Preferred stockholder of KKR & Co. Inc., and Messrs. Henry R. Kravis and George R. Roberts, as the founding partners of KKR Management LLP, may be deemed to be the beneficial owners having shared voting and investment power with respect to the shares described above. The principal business address of each of the entities identified in the immediately preceding sentence is 30 Hudson Yards, New York, NY 10001. The principal business address for Mr. Kravis is c/o Kohlberg Kravis Roberts & Co. L.P., 30 Hudson Yards, New York, NY 10001. The principal business address for Mr. Roberts is c/o Kohlberg Kravis Roberts & Co. L.P., 2800 Sand Hill Road, Suite 200, Menlo Park, CA 94025. Mr. Satvat is a member of the Board of Directors and serves as an executive of Kohlberg Kravis Roberts & Co. L.P. and/or one or more of its affiliates. Each of Messrs. Kravis, Roberts and Satvat disclaims beneficial ownership of the shares held by KKR Genetic Disorder L.P. |
(3) | Consists of 6,068,125 shares of common stock directly owned by Aisling Capital IV, LP (“Aisling”) and held indirectly by Aisling Capital Partners IV, LP (“Aisling GP”), as general partner of Aisling, Aisling Capital Partners IV LLC (“Aisling Partners”), as general partner of Aisling GP, and each of the individual managing members of Aisling Partners. The individual managing members (collectively, the “Managers”) of Aisling Partners are Dr. Andrew Schiff and Steve Elms. Aisling GP, Aisling Partners and the Managers share voting and dispositive power over the shares directly held by Aisling. Each of Aisling GP, Aisling Partners and the Managers may be deemed to be the beneficial owner of the securities listed above only to the extent of its pecuniary interest therein. The above information shall not be deemed an admission that any of Aisling GP, Aisling Partners or any of the Managers is the beneficial owner of any securities reported herein. The address of the principal business offices of each of these entities and individuals is 489 Fifth Avenue, 10th Floor, New York, NY 10017. |
(4) | Assumes that the Selling Stockholders dispose of all of their respective shares of common stock covered by this prospectus and do not acquire beneficial ownership of any additional shares of common stock. The registration of these shares of common stock does not necessarily mean that the Selling Stockholders will sell all or any portion of their respective shares of common stock covered by this prospectus. |
• | an underwritten offering; |
• | ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
• | block trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block as principal to facilitate the transaction; |
• | purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
• | an exchange distribution in accordance with the rules of the applicable exchange; |
• | privately negotiated transactions; |
• | settlement of short sales entered into after the effective date of the registration statement of which this prospectus is a part; |
• | broker-dealers may agree with the Selling Stockholders to sell a specified number of such shares at a stipulated price per share; |
• | through the writing or settlement of options or other hedging transactions, whether such options are listed on an options exchange or otherwise; |
• | a combination of any such methods of sale; and |
• | any other method permitted pursuant to applicable law. |
• | our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on February 23, 2023; |
• | our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, filed with the SEC on May 4, 2023; |
• | our Definitive Proxy Statement on Schedule 14A (other than information furnished rather than filed), filed with the SEC on April 28, 2023; |
• | our Current Reports on Form 8-K filed with the SEC on February 23, 2023 (with respect to Item 5.02 only), March 6, 2023 (with respect to Item 8.01 only), March 9, 2023, May 4, 2023 (for the report dated May 3, 2023), June 22, 2023 and July 17, 2023 (with respect to Item 8.01 only) (in each case, other than information furnished rather than filed); and |
• | the description of our common stock contained in Exhibit 4.3 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, filed with the SEC on February 5, 2022, including any amendments or reports filed for the purpose of updating such description. |
SEC registration fee* | | | $245,403.43 |
Legal fees and expenses | | | $60,000.00 |
Accounting fees and expenses | | | $15,000.00 |
Printing and miscellaneous expenses | | | $10,000.00 |
Total | | | $330,403.43 |
* | $237,509.53 of the registration fees with respect to the securities registered in this registration statement were previously paid on the Registrant’s registration statement on Form S-3ASR (No. 333-240147), filed on July 28, 2020 (the “Initial Registration Statement”). |
• | any breach of their duty of loyalty to our company or our stockholders; |
• | any act or omission not in good faith or that involves intentional misconduct or a knowing violation of law; |
• | unlawful payments of dividends or unlawful stock repurchases or redemptions as provided in Section 174 of the Delaware General Corporation Law; or |
• | any transaction from which they derived an improper personal benefit. |
Exhibit Number | | | Exhibit Title | | | Form | | | File No. | | | Exhibit | | | Filing Date |
| | Amended and Restated Certificate of Incorporation of the Registrant, as currently in effect. | | | 8-K | | | 001-38959 | | | 3.1 | | | July 3, 2019 | |
| | Amended and Restated Bylaws, as currently in effect. | | | S-4 | | | 333-249944 | | | 3.2 | | | November 6, 2020 | |
| | Specimen Common Stock Certificate. | | | S-1 | | | 333-231759 | | | 4.1 | | | June 24, 2019 | |
| | Fourth Amended and Restated Limited Liability Company Agreement, dated November 20, 2018, by and among BridgeBio Pharma LLC and its members. | | | S-1 | | | 333-231759 | | | 4.2 | | | May 24, 2019 | |
| | Form of Registration Rights Agreement, among the Registrant and certain of its shareholders. | | | S-1 | | | 333-231759 | | | 4.3 | | | June 24, 2019 | |
| | Opinion of Goodwin Procter LLP. | | | — | | | — | | | — | | | Filed herewith | |
| | Consent of Deloitte & Touche LLP, Independent Registered Public Accounting Firm. | | | — | | | — | | | — | | | Filed herewith | |
| | Consent of Goodwin Procter LLP (included in Exhibit 5.1 hereto). | | | — | | | — | | | — | | | Filed herewith | |
| | Power of Attorney (included in the signature pages to this registration statement). | | | — | | | — | | | — | | | Filed herewith | |
| | Filing Fee Table | | | | | | | | | Filed herewith |
(a) | The undersigned Registrant hereby undertakes: |
(1) | To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement: |
(i) | To include any prospectus required by section 10(a)(3) of the Securities Act; |
(ii) | To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in this registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20 percent change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and |
(iii) | To include any material information with respect to the plan of distribution not previously disclosed in this registration statement or any material change to such information in this registration statement; |
(2) | That, for the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered herein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
(3) | To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering. |
(4) | That, for the purpose of determining liability under the Securities Act to any purchaser: |
(i) | Each prospectus filed by the Registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and |
(ii) | Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii) or (x) for the purpose of providing the information required by Section 10(a) of the Securities Act shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date. |
(5) | The undersigned Registrant hereby further undertakes that, for the purposes of determining any liability under the Securities Act, each filing of the annual reports of the Registrant pursuant to Section 13(a) or |
(6) | Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the Registrant has been advised that in the opinion of the Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue. |
| | BridgeBio Pharma, Inc. | ||||
| | | | |||
| | By: | | | /s/ Neil Kumar, Ph.D. | |
| | | | Neil Kumar, Ph.D. President, Chief Executive Officer and Director (Principal Executive Officer) |
Signature | | | Title | | | Date |
/s/ Neil Kumar | | | President, Chief Executive Officer and Director (Principal Executive Officer) | | | July 26, 2023 |
Neil Kumar, Ph.D. | | | ||||
| | | | |||
/s/ Brian Stephenson | | | Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) | | | July 26, 2023 |
Brian Stephenson, Ph.D., CFA | | | ||||
| | | | |||
/s/ Eric Aguiar | | | Director | | | July 26, 2023 |
Eric Aguiar, M.D. | | | | | ||
| | | | |||
/s/ Jennifer E. Cook | | | Director | | | July 26, 2023 |
Jennifer E. Cook | | | | | ||
| | | ||||
/s/ Douglas A. Dachille | | | Director | | | July 26, 2023 |
Douglas A. Dachille | | | | | ||
| | | | |||
/s/ Ronald J. Daniels | | | Director | | | July 26, 2023 |
Ronald J. Daniels | | | | | ||
| | | | |||
/s/ Andrea J. Ellis | | | Director | | | July 26, 2023 |
Andrea J. Ellis | | | | | ||
| | | |
Signature | | | Title | | | Date |
/s/ Fred Hassan | | | Director | | | July 26, 2023 |
Fred Hassan | | | | | ||
| | | | |||
/s/ Charles Homcy | | | Director | | | July 26, 2023 |
Charles Homcy, M.D. | | | | | ||
| | | | |||
/s/ Andrew W. Lo | | | Director | | | July 26, 2023 |
Andrew W. Lo, Ph.D. | | | | | ||
| | | | |||
/s/ Frank P. McCormick | | | Director | | | July 26, 2023 |
Frank P. McCormick, Ph.D. | | | | | ||
| | | | |||
/s/ James C. Momtazee | | | Director | | | July 26, 2023 |
James C. Momtazee | | | | | ||
| | | | |||
/s/ Ali Satvat | | | Director | | | July 26, 2023 |
Ali Satvat | | | | | ||
| | | | |||
/s/ Randal Scott | | | Director | | | July 26, 2023 |
Randal Scott, Ph.D. | | | | | ||
| | | | |||
/s/ Hannah Valantine | | | Director | | | July 26, 2023 |
Hannah Valantine, M.D. | | | | |
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Goodwin Procter LLP
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Three Embarcadero Center
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San Francisco, CA 94111
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goodwinlaw.com
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+1 415 733 6000
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Re: |
Securities Registered under Registration Statement on Form S-3
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Very truly yours,
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/s/ Goodwin Procter LLP |
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GOODWIN PROCTER LLP |
Security
Type
|
Security
Class
Title
|
Fee
Calculation
or Carry
Forward
Rule
|
Amount
Registered (1)
|
Proposed
Maximum
Offering
Price Per
Unit (2)
|
Maximum
Aggregate
Offering
Price
|
Fee
Rate
|
Amount of
Registration
Fee
|
Carry
Forward
Form
Type
|
Carry
Forward
File
Number
|
Carry
Forward
Initial
effective
date
|
Filing Fee
Previously
Paid In
Connection
with Unsold
Securities to
be Carried
Forward
|
|
Newly Registered Securities
|
||||||||||||
Fees to Be Paid
|
Equity
|
Common Stock,
par value $0.001 per share (1)
|
457(r)
|
2,078,713
|
$34.46
|
$71,632,449.98
|
0.0001102
|
$7,893.90(3)
|
||||
Carry Forward Securities
|
||||||||||||
Carry Forward Securities
|
Equity
|
Common Stock,
par value
$0.001 per share
|
415(a)(6)
|
60,171,374(4)
|
—
|
$1,829,819,377.24(4)
|
—
|
—
|
S-3ASR(4)
|
333-240147(4)
|
July 28, 2020(4)
|
$237,509.53(4)
|
Total Offering Amounts
|
$1,901,443,933.32(4)
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(4)
|
—
|
|||||||||
Total Fees Previously Paid
|
(4)
|
—
|
||||||||||
Total Fee Offsets
|
(4)
|
—
|
||||||||||
Net Fee Due
|
$7,893.90(5)
|
—
|
(1)
|
In the event of a stock split, reverse stock split, stock dividend or similar transaction involving the Registrant’s common stock, the number of shares registered shall automatically be adjusted to cover the additional shares of common
stock issuable pursuant to Rule 416 under the Securities Act of 1933, as amended (the “Securities Act”).
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(2)
|
Estimated solely for the purposes of computing the registration fee in accordance with Rule 457(c) under the Securities Act, based on the average of the high and low prices of the Registrant’s common stock as reported on The Nasdaq Global
Select Market on July 19, 2023.
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(3)
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Consists of a total of 2,078,713 additional shares of common stock registered for resale by the selling securityholders named in this registration statement, the filing fee for which was not previously paid in connection with the Expiring
Registration Statement (as defined in Footnote 4).
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(4)
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We previously registered for resale on Form S-3ASR (No. 333-240147) (the “Expiring Registration Statement”) (i) 65,121,37 (the “previously offered securities”). In connection with the filing of the Expiring Registration Statement, we made
a fee payment in the amount of $257,048.26 in relation to the shares of underlying common stock calculated pursuant to Rule 457(c) under the Securities Act. As of the date of this registration statement, 60,171,374 shares of the previously
offered securities remain unsold. Pursuant to Rule 415(a)(6) under the Securities Act, this registration statement includes the 60,171,374 shares of the previously securities covered by the Expiring Registration Statement, and the
registration fee that has already been paid and remains unused with respect to such securities will be applied to the securities being registered pursuant to this registration statement. In accordance with Rule 415(a)(6) under the Securities
Act, the offering of the unsold securities under the Expiring Registration Statement will be terminated upon the filing of this registration statement.
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(5)
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No registration fee is payable in connection with the previously offered securities as the registration fee that has already been paid and remains unused with respect to such securities will be applied to the securities being registered
pursuant to this registration statement. The $7,893.90 relates solely to the 2,078,713 additional shares of common stock being registered pursuant to this registration statement that were not registered on the Expiring Registration
Statement.
|