UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE TO
TENDER OFFER STATEMENT UNDER SECTION
14(D)(1)
OR 13(E)(1) OF THE SECURITIES EXCHANGE ACT OF 1934
IMMUNOMEDICS, INC.
(Name of Subject Company (Issuer))
MAUI MERGER SUB, INC.
a wholly owned subsidiary of
GILEAD SCIENCES, INC.
(Names of Filing Persons (Offeror))
Common Stock, Par Value $0.01 Per Share
(Title of Class of Securities)
452907108
(Cusip Number of Class of Securities)
Brett A. Pletcher, Esq.
Executive Vice President, Corporate Affairs
and General Counsel
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
650-574-3000
(Name, Address and Telephone Number of Person
Authorized to Receive Notices and Communications on Behalf of Filing Persons)
With copies to:
Marc O. Williams Cheryl Chan
| |
CALCULATION OF FILING FEE | |
Transaction Valuation* |
Amount of Filing Fee* |
N/A | N/A |
* | A filing fee is not required in connection with this filing as it relates solely to preliminary communications made before the commencement of the tender offer. |
☐ | Check box if any part of the fee is offset as provided by Rule 0-11(a)(2) and identify the filing with which the offsetting fee was previously paid. Identify the previous filing by registration statement number, or the Form or Schedule and the date of its filing. |
Amount Previously Paid: | Not applicable | Filing Party: | Not applicable |
Form or Registration No.: | Not applicable | Date Filed: | Not applicable |
☒ Check the box if the filing relates solely to preliminary communications made before the commencement of a tender offer. Check the appropriate boxes below to designate any transactions to which the statement relates:
☒ | third-party tender offer subject to Rule 14d-1. |
☐ | issuer tender offer subject to Rule 13e-4. |
☐ | going-private transaction subject to Rule 13e-3. |
☐ | amendment to Schedule 13D under Rule 13d-2. |
Check the following box if the filing is a final amendment reporting the results of the tender offer.
This filing relates solely to preliminary communications made before the commencement of a tender offer by Maui Merger Sub, Inc., a Delaware corporation (“Purchaser”) and a wholly owned subsidiary of Gilead Sciences, Inc., a Delaware corporation (“Gilead”), to acquire all of the outstanding shares of common stock of Immunomedics, Inc., a Delaware corporation (“Immunomedics”), at a price of $88.00 per share, net to the seller in cash, without interest, pursuant to an Agreement and Plan of Merger, dated September 13, 2020, among Immunomedics, Gilead and Purchaser.
Forward-Looking Statements
This document contains forward-looking statements, related to Gilead, Immunomedics and the acquisition of Immunomedics by Gilead that are subject to risks, uncertainties and other factors. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including all statements regarding: the intent, belief or current expectation of the companies’ and members of their senior management team. Forward-looking statements include, without limitation, statements regarding the business combination and related matters, prospective performance and opportunities, post-closing operations and the outlook for the companies’ businesses, including, without limitation, the ability of Gilead to advance Immunomedics’ product pipeline and successfully commercialize Trodelvy; expectations for achieving full U.S. Food and Drug Administration approval based on Immunomedics’ confirmatory data for Trodelvy and Immunomedics’ development of Trodelvy for additional indications; clinical trials (including the anticipated timing of clinical data, the funding therefor, anticipated patient enrollment, trial outcomes, timing or associated costs); the possibility of unfavorable results from clinical trials; regulatory applications and related timelines, including the filing and approval timelines for Biologics License Applications and supplements; filings and approvals relating to the transaction; the expected timing of the completion of the transaction; the ability to complete the transaction considering the various closing conditions; difficulties or unanticipated expenses in connection with integrating the companies; and any assumptions underlying any of the foregoing. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties. Risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include: uncertainties as to the timing of the tender offer and merger; uncertainties as to how many of Immunomedics’ stockholders will tender their stock in the offer; the possibility that competing offers will be made; the possibility that various closing conditions for the transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the effects of the transaction on relationships with employees, other business partners or governmental entities; the difficulty of predicting the timing or outcome of regulatory approvals or actions, if any; Immunomedics’ ability to meet post-approval compliance obligations (on topics including but not limited to product quality, product distribution and supply chain requirements, and promotional and marketing compliance); imposition of significant post-approval regulatory requirements on Immunomedics’ products, including a requirement for a post-approval confirmatory clinical study, or failure to maintain (if received) or obtain full regulatory approval for Immunomedics’ products due to a failure to satisfy post-approval regulatory requirements, such as the submission of sufficient data from a confirmatory clinical study; the impact of competitive products and pricing; other business effects, including the effects of industry, economic or political conditions outside of the companies’ control; transaction costs; actual or contingent liabilities; adverse impacts on business, operating results or financial condition in the future due to pandemics, epidemics or outbreaks, such as COVID-19; and other risks and uncertainties detailed from time to time in the companies’ periodic reports filed with the U.S. Securities and Exchange Commission (the “SEC”), including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K, as well as the Schedule 14D-9 to be filed by Immunomedics and the Schedule TO and related tender offer documents to be filed by Gilead and Purchaser. All forward-looking statements are based on information currently available to Gilead and Immunomedics, and Gilead and Immunomedics assume no obligation and disclaim any intent to update any such forward-looking statements.
Additional Information and Where to Find It
The tender offer described in this document has not yet commenced. This document is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares of Immunomedics, nor is it a substitute for any tender offer materials that Gilead, Purchaser or Immunomedics will file with the SEC. A solicitation and an offer to buy shares of Immunomedics will be made only pursuant to an offer to purchase and related materials that Gilead intends to file with the SEC. At the time the tender offer is commenced, Gilead will file a Tender Offer Statement on Schedule TO with the SEC, and Immunomedics will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. IMMUNOMEDICS’ STOCKHOLDERS AND OTHER INVESTORS ARE URGED TO READ THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION WHICH SHOULD BE READ CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. The Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, will be sent to all stockholders of Immunomedics at no expense to them. The Tender Offer Statement and the Solicitation/Recommendation Statement will be made available for free at the SEC’s web site at www.sec.gov. Additional copies may be obtained for free by contacting Gilead or Immunomedics. Free copies of these materials and certain other offering documents will be made available by Gilead by mail to Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404, attention: Investor Relations, by phone at 1-800-GILEAD-5 or 1-650-574-3000, or by directing requests for such materials to the information agent for the offer, which will be named in the Tender Offer Statement. Copies of the documents filed with the SEC by Immunomedics will be available free of charge under the “Investors” section of Immunomedics’ internet website at Immunomedics.com.
In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Gilead and Immunomedics file annual, quarterly and current reports, proxy statements and other information with the SEC. Gilead’s and Immunomedics’ filings with the SEC are also available for free to the public from commercial document-retrieval services and at the website maintained by the SEC at www.sec.gov.
EXHIBIT INDEX
Exhibit No. |
Description |
99.1 | Investor Presentation, dated September 13, 2020. |
99.2 | Transcript of Investor Presentation Call on September 13, 2020. |
99.3 | Frequently Asked Questions sent to Gilead Operating Group on September 14, 2020. |
99.4 | Frequently Asked Questions provided by Gilead to Immunomedics, Inc. Employees on September 14, 2020. |
99.5 | Tweet posted by Gilead on September 13, 2020. |
99.6 | Email sent by Gilead to Immunomedics, Inc.’s Employees on September 13, 2020. |
Exhibit 99.1
Gilead to Acquire Immunomedics S e p t e m b e r 13, 2020
The tender offer described in this document has not yet commenced . This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares of Immunomedics, nor is it a substitute for any tender offer materials that Gilead, Maui Merger Sub, Inc . or Immunomedics will file with the SEC . A solicitation and an offer to buy shares of Immunomedics will be made only pursuant to an offer to purchase and related materials that Gilead intends to file with the SEC . At the time the tender offer is commenced, Gilead will file a Tender Offer Statement on Schedule TO with the SEC, and Immunomedics will file a Solicitation/Recommendation Statement on Schedule 14 D - 9 with the SEC with respect to the tender offer . IMMUNOMEDICS’ STOCKHOLDERS AND OTHER INVESTORS ARE URGED TO READ THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION WHICH SHOULD BE READ CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER . The Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, will be sent to all stockholders of Immunomedics at no expense to them . The Tender Offer Statement and the Solicitation/Recommendation Statement will be made available for free at the SEC’s web site at www . sec . gov . Additional copies may be obtained for free by contacting Gilead or Immunomedics . Free copies of these materials and certain other offering documents will be made available by Gilead by mail to Gilead Sciences, Inc . , 333 Lakeside Drive, Foster City, CA 94404 , attention : Investor Relations, by phone at 1 - 800 - GILEAD - 5 or 1 - 650 - 574 - 3000 , or by directing requests for such materials to the information agent for the offer, which will be named in the Tender Offer Statement . Copies of the documents filed with the SEC by Immunomedics will be available free of charge under the “Investors” section of Immunomedics’ internet website at Immunomedics . com . In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Gilead and Immunomedics file annual, quarterly and current reports, proxy statements and other information with the SEC . Gilead’s and Immunomedics’ filings with the SEC are also available for free to the public from commercial document - retrieval services and at the website maintained by the SEC at www . sec . gov . Forward - Looking Statements This communication contains forward - looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 , related to Gilead, Immunomedics and the acquisition of Immunomedics by Gilead that are subject to risks, uncertainties and other factors . All statements other than statements of historical fact are statements that could be deemed forward - looking statements, including all statements regarding the intent, belief or current expectation of the companies’ and members of their senior management team . Forward - looking statements include, without limitation, statements regarding the business combination and related matters, prospective performance and opportunities, post - closing operations and the outlook for the companies’ businesses, including, without limitation, the ability of Gilead to advance Immunomedics’ product pipeline and successfully commercialize Trodelvy; expectations for achieving full U . S . Food and Drug Administration approval based on Immunomedics’ confirmatory data for Trodelvy and Immunomedics’ development of Trodelvy for additional indications; clinical trials (including the anticipated timing of clinical data; the funding therefor, anticipated patient enrollment, trial outcomes, timing or associated costs); the possibility of unfavorable results from clinical trials; regulatory applications and related timelines, including the filing and approval timelines for Biologics License Applications and supplements; filings and approvals relating to the transaction; the expected timing of the completion of the transaction; the ability to complete the transaction considering the various closing conditions; difficulties or unanticipated expenses in connection with integrating the companies; and any assumptions underlying any of the foregoing . Investors are cautioned that any such forward - looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward - looking statements . Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties . Risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward - looking statements include : uncertainties as to the timing of the tender offer and merger; uncertainties as to how many of Immunomedics’ stockholders will tender their stock in the offer; the possibility that competing offers will be made; the possibility that various closing conditions for the transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the effects of the transaction on relationships with employees, other business partners or governmental entities; the difficulty of predicting the timing or outcome of regulatory approvals or actions, if any; Immunomedics’ ability to meet post - approval compliance obligations (on topics including but not limited to product quality, product distribution and supply chain requirements, and promotional and marketing compliance); imposition of significant post - approval regulatory requirements on Immunomedics’ products, including a requirement for a post - approval confirmatory clinical study, or failure to maintain (if received) or obtain full regulatory approval for Immunomedics’ products due to a failure to satisfy post - approval regulatory requirements, such as the submission of sufficient data from a confirmatory clinical study; the impact of competitive products and pricing; other business effects, including the effects of industry, economic or political conditions outside of the companies’ control; transaction costs; actual or contingent liabilities; adverse impacts on business, operating results or financial condition in the future due to pandemics, epidemics or outbreaks, such as COVID - 19 ; and other risks and uncertainties detailed from time to time in the companies’ periodic reports filed with the U . S . Securities and Exchange Commission (the “SEC”), including current reports on Form 8 - K, quarterly reports on Form 10 - Q and annual reports on Form 10 - K, as well as the Schedule 14 D - 9 to be filed by Immunomedics and the Schedule TO and related tender offer documents to be filed by Gilead and Maui Merger Sub, Inc . , a wholly owned subsidiary of Gilead . All forward - looking statements are based on information currently available to Gilead and Immunomedics, and Gilead and Immunomedics assume no obligation and disclaim any intent to update any such forward - looking statements . 2 Additional I n f o r m atio n and Where to Find It
Gilead is Executing Upon our Corporate Strategy 3 Long - T e r m Ambitions S tr a t eg i c P r i o r i t i e s Bring 10+ Transformative Therapies to Patients by 2030 Be the Biotech Employer and Partner of Choice Deliver Shareholder Value in a Sustainable, Responsible Manner Strengthen Portfolio Strategy and Decision - Making Increase Patient Access and Benefit Continue to Evolve our Culture Expand Internal and External Innovation
Gilead Acquires Immunomedics to Further Transform Oncology Portfolio 4 Gilead to acquire Immunomedics for a total purchase price of ~$21 billion Adds Trodelvy TM , a first - in - class antib for 3L+ metastatic triple - negative br ody drug conjugate (ADC) approved east cancer (mTNBC) 1 Significant efficacy benefit vs. chemotherapy driving early adoption with potential to become standard of care in advanced TNBC Ongoing registrational studies in H clinical activity demonstrated across m R+/HER2 - mBC and urothelial cancer; ultiple other solid tumor types Five data presentations at ESMO 2020 this coming week, including phase 3 ASCENT and phase 2 TROPHY U - 01 studies 1 TRODELVY (sacituzumab govitecan - hziy) is indicated for the treatment of adult patients with metastatic triple - negative breast cancer (mTNBC) who have received at least 2 prior therapies for metastatic disease; this indication was approved under accelerated approval based on tumor response rate and duration of response; continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Fully integrated oncology company with 430 full - time employees Trodelvy is a foundational, first - in - class commercial product with potential to be best - in - class and drive significant revenue growth Impressive talent and expertise of Immunomedics’ employees augment our existing capabilities in oncology
Strong Strategic Fit 5 x Approved transformational medicine with potential to provide benefit across a broad range of solid tumors x Accelerates entry into solid tumors with immediate presence in breast cancer x Emerging data supports expansion into multiple solid tumors , including 3L+ HR+/HER2 - metastatic breast cancer and 3L+ urothelial cancer x Complements pipeline with opportunities to explore combinations with internal and external immuno - oncology (IO) and other agents x Provides foundation to advance solid tumor portfolio x Diversifies marketed portfolio beyond antivirals and has potential to deliver significant revenue growth +
Select pre - clinical Phase 1 Phase 2 Phase 3 Marketed Hematology Solid Tumors Magrolimab NHL KITE - 222 CLL - 1 AML Brexu - cel CLL Brexu - cel Pediatric ALL 1 Axi - cel 1L DLBCL M ag r o li m ab AML Axi - cel ( + l en z il u m ab ) 3L DLBCL Brexu - cel Adult ALL 1 A x i - c e l iNHL 1 SG 3L mTNBC (ASCENT) SG 3L+ HR+/ H E R 2 - m BC SG Basket study (incl. NSCLC) SG 3L+ UC SG (+ CPI) mBC, mUC, mNSCLC Arcus AB154 TIGIT NSCLC 2 Z i m be r e li m a b PD - 1 NSCLC 3 Arcus AB928 Adenosine mCRC 2 JT X - 1811 CCR8 Solid tumors GS - 3583 FLT3R agonist Oncology Magrolimab Solid tumors GS - 9716 MCL1 inhib. Oncology Sacituzumab govitecan (SG) mTNBC, mUC, Ovarian (+ PARPi) A G E N 2373 CD137 Solid tumors 2 AGEN1223 Bi - specific Solid tumors 2 GS - 1423 CD73/TGFβ Solid tumors Ar c us CD 7 3 Solid tumors 2 GS - 422 4 PD - L1 NSCLC Tizona TTX - 080 HLA - G Solid tumors 2,4 Pionyr PY314 TREM2 Solid Tumors 2,4 KITE - 718 MAGE - A3/A6 Solid tumor KITE - 439 HPV - 16 E7 Solid tumor Magrolimab MDS, NHL, AML KITE - 363 Dual targeting r/r DLBCL GS - 0189 An t i - S IR P ɑ Oncology Axi - cel 3L ( + u t o m il u m ab ) DLBCL KITE - 037 Allo - HD CD19 r/r DLBCL Axi - cel ( + m a v rili m u m ab) 3L DLBCL Axi - cel ( + ri t u x i m ab) 3L DLBCL Axi - cel 2L DLBCL 1 Pivotal P2 study. 2 Optionable Partner Program 3 In - licensed from Arcus. 4 Tizona and Pionyr have not had FPI for their phase 1. Brexu - cel - brexucabtagene autoleucel, formerly KTE - X19. ALL - Acute lymphocytic leukemia. CLL - Chronic lymphocytic leukemia. DLBCL - Diffuse large B - cell lymphoma. iNHL - Indolent non - Hodgkin lymphoma. MCL - Mantle cell lymphoma. r/r - relapsed refractory. CPI - Checkpoint inhibitors. Selected pre - clinical assets displayed. Expanding Gilead and Kite Oncology Pipeline with Immunomedics 6 Internal sourced Externally sourced within last 2 years Gained from Immunomedics KEY Cell Therapy Pionyr PY159 TREM1 Solid Tumors 2,4
Select Internal Assets: PD - L1 small molecule (GS - 4224) MCL1 inhibitor (GS - 9716) FLT3R agonist (GS - 3583) MAGE A3/A6 (KTE - 718) CLL - 1 (KTE - 222) HPV - 16 E7 (KTE - 439) Accelerating Buildout of Gilead and Kite Oncology Portfolio and Expertise 7 Magrolimab (CD - 47) Zimberelimab (PD - 1) Domvanalimab (TIGIT) Etrumadenant (A2a/A2bR) + others PY314 (TREM2) PY159 (TREM1) 2 TTX - 080 (HLA - G) IO Discovery Collaboration AGEN2373 (CD137) GS - 1423 (CD73/TGFβ) F i r s t - i n - c l as s conjugate for JTX - 1811 (CCR8) antibody drug triple negative IO Discovery Collaboration BCMA Antibodies for Cell Therapy b r eas t Novel AML Targets for Cell Therapy cancer 1 Discovery Collaboration for Cell Therapy Protein Degradation Discovery Collaboration 1 TRODELVY (sacituzumab govitecan - hziy) is indicated for the treatment of adult patients with metastatic triple - negative breast cancer (mTNBC) who have received at least 2 prior therapies for metastatic disease; This indication is approved under accelerated approval based on tumor response rate and duration of response; Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. 2 Agreement regarding this transaction announced, but not yet closed. Closing of this transaction is subject to antitrust clearance and other conditions. Building internal pipeline with 13 tailored transactions to access external innovation in last 2 years
Trodelvy Overview 8 • Trodelvy (sacituzumab govitecan) is the first ADC approved for r/r metastatic triple negative breast cancer - Highly specific antibody targets Trop - 2, an epithelial antigen over - expressed across a range of solid tumors - Validated SN - 38 payload kills cancers by damaging DNA - Hydrolysable linker facilitates intra - and extra - cellular (bystander effect) killing of tumor cells • Trodelvy has demonstrated activity across a range of solid tumors , including HR+/HER2 - metastatic breast and urothelial cancers • Broad development program offers potential expansion opportunities Humanized anti - Trop - 2 antibody • Targets Trop - 2, an epithelial antigen expressed on a range of solid tumors SN - 38 payload • SN - 38 is the active metabolite of irinotecan Linker for SN - 38 • Hydrolysable linker for payload release
Trodelvy Approved for 3L+ Metastatic Triple - Negative Breast Cancer 9 • FDA granted accelerated approval in 3L+ mTNBC in April 2020 based on 33% ORR observed in Phase 1/2 IMMU - 132 - 01 study 3 • Confirmatory phase 3 ASCENT study stopped early due to compelling efficacy ; met primary and key secondary endpoints including OS and ORR • Safety profile observed in ASCENT study consistent with FDA - approved label • Full ASCENT dataset will be presented this coming week at ESMO • sBLA submission for full approval expected in Q4 2020 PFS (months) Erib, Cap, Gem or Vin in 3L Trodelvy in 3L 1 . 7 2 5 . 6 2 Source: Company filings, equity research and Immunomedics investor presentation. 1 Study enrolled a total of 529 patients; Per protocol, PFS analysis excludes patients with positive brain metastases. 2 July 2020 Immunomedics press release. 3 TRODELVY™ (sacituzumab govitecan - hziy) is indicated for the treatment of adult patients with metastatic triple - negative breast cancer (mTNBC) who have received at least 2 prior therapies for metastatic disease. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. 3L Triple Negative Breast Cancer Ph. 3 (ASCENT, N=529 1 )
Promising Clinical Data In Other Tumors 10 HR+/HER2 - Metastatic Breast Cancer Metastatic Urothelial Cancer Ph. 1/2 (IMMU132 - 01) Ph. 1/2 (IMMU132 - 01); Ph. 2 (TROPHY U - 01) Source: Company filings, equity research and Immunomedics investor presentation. 1 Kazmi S, ESMO 2019 Abstract 366P. 2 Eribulin, capecitabine, or vinorelbine in 2L/3L; Jones S, JCO 1995; Kaufman PA, JCO 2015; Kazmi S, ESMO 2019 Abstract 366P 3 Kalinsky K, SABCS 2018. 4 Tagawa S, JCO 2019. 5 May 2020 Immunomedics press release; interim data includes ORR from cohorts 1 & 2 and PFS from cohort 2; full topline data from cohort 1 expected at ESMO 2020. 6 Vinflunine or docetaxel in 2L; Bellmunt J, JCO 2009; Petrylak D, JCO 2016; Petrylak D, Lancet 2017 Achieved Strong ORR and PFS in 3 rd line+ HR+/HER2 - metastatic breast cancer and metastatic urothelial cancer Sacituzumab govitecan (SG) in 3L+ Historical SOC data 2 ORR of 11 - 13% N=54 Historical SOC data 2 PFS of 2.5 - 3.1 N=54 6 . 8 3 IMMU - 132 - 01 SG data, cisplatin ineligible patients in 3L+ mUC TROPHY U - 01 SG data, cisplatin ineligible patients in 3L+ mUC Historical SOC data 6 ORR of 9 - 14% 7 . 3 4 29 % 5 5 . 5 5 N=45 N=35 Historical SOC data 6 PFS of 2.8 - 3.0 ORR (%) PFS (months) 31% 4 ORR (%) PFS (months) 31% 1 N=45 N=21
Multiple Opportunities to Improve Patient Outcomes with Trodelvy 11 Potential Expansion Indications HR+/HER2 - BC Urothelial cancer NSCLC SCLC Gastric cancer Esophageal cancer Head & neck cancer CRPC Endometrial cancer Potential Combinations Checkpoint inhibitors PARP inhibitors Other IO agents Earlier Lines of Therapy Approved for 3L+ mTNBC HR+/HER2 - mBC = Hormone Receptor positive, human epidermal growth factor receptor 2 negative metastatic breast cancer. Urothelial cancer. NSCLC = Non Small Cell Lung Cancer. SCLC = Small Cell Lung Cancer. CRPC = Castrate Resistant Prostate Cancer.
Breadth of Trodelvy Studies Provides Opportunity for Expansion 12 Trial Indication Phase 1 Phase 2 Phase 3 Approved IMMU - 132 - 01 mTNBC (3L+) ASCENT mTNBC (3L) S tudy stopped early due to compelling efficacy TROPiCS - 02 HR+/HER2 - mBC (3L+) TROPHY U - 01 Urothelial (3L+) P o t e n tially registrational TROPiCS - 03 Basket (mNSCLC / H&N / mSCLC / endometrial / HCC) MORPHEUS mTNBC (1L) / mUC / mNSCLC (+Tecentriq) SEASTAR mTNBC / mUC / Ovarian (2L+) (+ Rubraca) Source: Company Investor Presentation May 2020 and equity research. Information regarding partnerships is subject to confirmation in legal diligence. 1 Clinical pipeline shown does not include investigator sponsored trials (ISTs). These ISTs include collaborations 1) with German Breast Group to evaluate Trodelvy in HER2 - breast cancer in the post - neoadjuvant setting, 2) with Dana Farber Cancer Institute and Merck to evaluate Trodelvy + Keytruda in advanced breast cancers, 3) with Massachusetts General Hospital to evaluate Trodelvy in TNBC in the neoadjuvant setting and Trodelvy + Talzenna in 2L mTNBC, and 4) has further collaborations with Yale, U of Wisconsin and UT Health at San Antonio to evaluate Trodelvy in other solid tumor types. 2 Partnered with Everest for oncology in Greater China, South Korea and part of Southeast Asia in exchange for 1) $65m upfront; 2) $60m milestone on U.S. FDA Approval in mTNBC; 3) R&D and commercial milestones of up to $710m; and 4) tiered mid - teens royalties.
Key Near - Term Trodelvy Milestones ESMO 2020: Full Phase 3 ASCENT data in 3L metastatic triple - negative breast cancer (to be presented 9/19) ESMO 2020: Top - line pivotal Phase 2 TROPHY - U01 Cohort 1 data in 3L metastatic urothelial cancer (to be presented 9/19) sBLA submission for full approval in metastatic triple - negative breast cancer EU submission in metastatic 3L triple - negative breast cancer Interim data from Phase 3 TROPICS - 02 data in 3L HR+/HER2 - metastatic breast cancer Potential sBLA submission in 3L urothelial cancer 13 Plan to initiate additional registrational studies in 2021 and beyond to maximize patient benefit Q3 2020 Q4 2020 H1 2021 ESMO 19 - 21 st Sep 2020
Transaction Details 14 Transaction provides immediate revenue diversification and significantly improves growth prospects • Gilead to acquire Immunome - Tender offer is not subject to a - Expect to fund acquisition with - Does not alter stated capital al dics for $88.00 per share in cash for a total purchase price of ~$21 billion financing condition ~$15 billion of existing cash and ~$6 billion in newly issued debt location strategy or commitment to maintain and grow dividend neutral or accretive to non - GAAP earnings in 2023 and significantly accretive • Transaction anticipated to be thereafter • Close expected in Q4 2020 , subject to regulatory approval and other customary closing conditions
Trodelvy Supports Strategy to Drive Additional Growth and Complements YTD Progress 15 Strategy to Drive Additional Growth x Trodelvy foundational asset for solid tumors x 15 tailored transactions YTD x Accelerating efforts to build IO portfolio and expertise x Optimizing portfolio through strategic evaluation Durable Core Business x Biktarvy #1 across markets x Descovy for PrEP launch success x HCV market share maintained x Growth in China continues Existing Pipeline Opportunities x Remdesivir for COVID - 19 x Tecartus approved for r/r MCL x Filgotinib positive European CHMP opinion for RA x Lenacapavir for long - acting HIV x Magrolimab for MDS and AML + + Well positioned to maximize near - term opportunities and achieve long - term success
THANK YOU CONTACT US investor_relations@gilead.com investors.gilead.com
Exhibit 99.2
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9 | AUDIO TRANSCRIPTION OF |
10 | GILEAD SCIENCES |
11 | CONFERENCE CALL |
12 | GILEAD TO ACQUIRE IMMUNOMEDICS |
13 | SEPTEMBER 13, 2020 |
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1 | MALE SPEAKER: Ladies and gentlemen, thank |
2 | you for standing by and welcome to the Gilead Sciences |
3 | conference call. At this time all participants are on |
4 | the listen only mode. After the speaker presentation |
5 | there will be a question-and-answer session. To ask a |
6 | question during the session, you would need to press |
7 | star 1 on your telephone. Please be advised that |
8 | today's conference is being recorded. If you require |
9 | any further assistance, please press star 0. I would |
10 | now like to hand the conference over to your speaker |
11 | today to Douglas Maffei, Senior Director Investor |
12 | Relations. Thank you, please go ahead. |
13 | MR. MAFFEI: Thank you Dalim (phonetic). |
14 | We appreciate everyone joining us on short notice for |
15 | today's call to discuss the exciting acquisition of |
16 | Immunomedics announced earlier today. The speakers on |
17 | today's call will be Daniel O'Day, Chairman and Chief |
18 | Executive Officer; Merdad Parsey, Chief Medical Officer; |
19 | Johanna Mercier, Chief Commercial Officer, and Andrew |
20 | Dickinson, Chief Financial Officer. |
21 | Before we begin, let me remind you that we |
22 | will be making forward-looking statements that are |
23 | subject to risks, uncertainties and other factors that |
24 | could cause actual results to differ materially from |
25 | those referred to in any forward-looking statements. |
1 | These risks and uncertainties are contained within our |
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2 | joint press release, presentation and latest SEC filings |
3 | of each company. I will now turn the call over to Dan. |
4 | MR. O'DAY: Thank you, Doug, very much and |
5 | good afternoon everyone. Really, thank you for joining |
6 | the call, especially on a Sunday. We are -- I speak on |
7 | behalf of the entire leadership team, we are very |
8 | excited to share this news with you today. It really is |
9 | a transformational acquisition that gives us tremendous |
10 | potential to help patients with cancer and generate |
11 | significant value. |
12 | So on today's call we wanted to articulate |
13 | the why behind the acquisition for Gilead and provide, |
14 | obviously, the opportunity for any questions that you |
15 | may have. So I'll start out and then I'll pass the |
16 | baton over to Merdad to talk about the potential of |
17 | Trodelvy. Johanna will then offer some insight from a |
18 | commercial perspective. And then, finally, Andy will |
19 | speak to the structure and the financial terms of the |
20 | transaction. |
21 | So as all of you know, we set a strategic |
22 | ambition at the start of this year to deliver more than |
23 | 10 transformative medicines and therapies to patients in |
24 | areas of high unmet medical needs. And as part of those |
25 | efforts we've been building a robust and diverse |
Page 4
1 | oncology portfolio. In fact, we'd already completed 12 |
2 | key deals in oncology in the last two years including |
3 | the acquisition of Forty Seven. |
4 | Now, upon closing our acquisition of |
5 | Immunomedics, we are fastforwarding our plan to build a |
6 | substantial oncology business with significant |
7 | potential. I mean, really, the shape of the portfolio |
8 | changes really significantly with this acquisition. |
9 | Trodelvy has tremendous potential and we |
10 | saw some of that in the standout data for triple- |
11 | negative breast cancer that led to the accelerated |
12 | approval. This medicine is highly innovative. It's an |
13 | antibody drug conjugate that has shown really |
14 | demonstrable efficacy in the area of very high unmet |
15 | medical needs. |
16 | In particular, the top line results that |
17 | Immunomedics shared in July from its phase 3-ASCENT |
18 | study provided significant evidence of clinical benefits |
19 | and confirmed findings from previous studies around the |
20 | safety and efficacy of Trodelvy. Trodelvy met the |
21 | primary endpoint of progression of pre-survival. |
22 | Trodelvy also met the key secondary endpoints including |
23 | most notably, overall survival as well as objective |
24 | response rate. But also highlight that we have reviewed |
25 | significantly more clinical data on the product over the |
Page 5
1 | past several months that gives us greater confidence in |
2 | the clinical benefit Trodelvy can provide. Some of that |
3 | data you'll be seeing at the upcoming ESMO conference |
4 | this coming weekend, and I know that Immunomedics looks |
5 | forward to sharing that with you. |
6 | On the commercial side, although the launch |
7 | is still early, the response from physicians and |
8 | patients has been very encouraging in triple-negative |
9 | breast cancer. We expect increased uptake among this |
10 | group of patients who are in dire need of new treatment |
11 | options. While it is already begun to play an important |
12 | role in triple-negative breast cancer today, we also |
13 | recognize the promise that Trodelvy potentially offers |
14 | for many other groups of patients. |
15 | We'll work with Immunomedics to continue to |
16 | explore its potential in earlier lines of therapy and in |
17 | other solid tumors, both as a monotherapy and in |
18 | combination. I mean, it's really a pipeline in a |
19 | product when we think about this from an oncology |
20 | perspective. If we look at Trodelvy in the context of |
21 | our overall oncology portfolio after closing the |
22 | transaction, we'll be adding a transformative |
23 | cornerstone therapy that gives us an immediate presence |
24 | in solid tumors. We are gaining the considerable |
25 | talented expertise that Immunomedics has in this field |
Page 6
1 | and a first-in-class marketed product. This accelerates |
2 | our expansion into solid tumors and builds on our |
3 | existing strengths in hematologic cancers to our |
4 | combined Kite and Gilead pipeline. |
5 | From a financial perspective, following the |
6 | closing of the transaction, Trodelvy will immediately |
7 | contribute revenue and will significantly enhance our |
8 | growth prospects in the near term and longer term. We |
9 | expect the acquisition to create significant value for |
10 | our shareholders. The transaction reflects the |
11 | potential value as well as its synergy that it brings to |
12 | our existing platform and our future pipeline. |
13 | And finally, let me say that we're looking |
14 | forward to welcoming the team from Immunomedics to the |
15 | Gilead Family. The kind of achievements that they have |
16 | made with Trodelvy are only possible when you have |
17 | really talented individuals in place with strong |
18 | expertise and commitment. We feel very fortunate that |
19 | we'll have the opportunity to benefit from their talent |
20 | and expertise at Gilead as we continue to build a strong |
21 | presence in oncology and work to make a positive impact |
22 | on the treatment of cancer. |
23 | Finally, I want to thank all the talented |
24 | Gilead and Kite teams for their critical work on |
25 | advancing our pipeline of medicine in oncology and in |
1 | virology and inflammation. I'm proud of our momentum, |
Page 7
2 | proud to be a part of the team, which I now look forward |
3 | to building on with today's acquisition. |
4 | So with that, let me turn the call over to |
5 | Merdad. Over to you, Merdad. |
6 | DR. PARSEY: Thanks Dan. And I want to |
7 | start by saying that I'm also -- it's been very |
8 | impressive to see the growing body of data both |
9 | scientifically and clinically supporting the use of |
10 | Trodelvy. You know, the phase 3 data from ASCENT really |
11 | reinforced the premise of Trodelvy's unique ADC |
12 | technology and validates the promise of the TROP-2 |
13 | targeting therapy. Clearly, this groundbreaking |
14 | medicine, and in particular, in an area of high unmet |
15 | need that represents a new standard of care in this |
16 | disease. |
17 | In following this closely, it gives us the |
18 | foundation we need to build a presence and a pipeline in |
19 | solid tumor cancer. The importance of this agent is |
20 | further reflected in its targeting of TROP-2 which has |
21 | shown overexpression in multiple tumor types, including |
22 | non-small cell lung cancer, urothelial cancer, hormone |
23 | receptor positive for 2-negative breast cancer and |
24 | others. |
25 | Let me specifically pick up on one of the |
1 | themes that Dan mentioned around unmet need. Despite |
2 | available therapies, triple-negative breast cancer |
3 | remains a difficult to treat tumor that |
4 | disproportionately affects younger women and has poor |
5 | outcome. The transformative nature of Trodelvy is |
6 | reflected in the FDA accelerated approval based on the |
Page 8
7 | phase 1-2 trial. And in that study we saw an impressive |
8 | 33 percent overall response rate compared to the |
9 | standard of care chemotherapy response rate if it were |
10 | less than 20 percent. |
11 | The confirmatory randomized phase 3 ASCENT |
12 | study in TNBC patients, who were patients who had |
13 | received two or more prior therapies for metastatic |
14 | disease, further demonstrated the benefit of the drug. |
15 | In particular, it's notable that this study was stopped |
16 | early due to the compelling efficacy seen with the |
17 | progression pre-survival signal of 5.8 months compared |
18 | with the control arm of chemotherapy of 1.7 months. |
19 | This had a P value of less than point 0001. |
20 | Importantly, Trodelvy was generally well |
21 | tolerated in this study with the most common adverse |
22 | events being neutropenia and diarrhea. Additional data, |
23 | including the overall survival data that we've had the |
24 | opportunity to review during our diligence will be |
25 | available at ESMO this coming week. |
Page 9
1 | The data for Trodelvy suggests that it's a |
2 | potentially transformative therapy in the treatment of |
3 | triple-negative breast cancer. Importantly, upcoming |
4 | clinical trials will also explore the potential benefit |
5 | across a range of expanded tumor types in earlier lines |
6 | of therapy. With potential breadth of Trodelvy in solid |
7 | tumors is a really compelling prospect for us in terms |
8 | of expanding the benefit to other patient groups. |
9 | Importantly, this includes a pivotal phase 2 study |
10 | called TROPHY U-01 in patients with metastatic |
11 | urothelial cancer following prior treatment with |
12 | platinum-based chemotherapy. |
13 | We look forward to multiple presentations |
14 | at the upcoming ESMO Conference, and this will highlight |
15 | some of this work as well as other work exploring |
16 | special combinations with PARP inhibitors and checkpoint |
17 | inhibitors. Let me hand off the call now to Johanna. |
18 | MS. MERCIER: Thanks, Merdad. So I really |
19 | echo the excitement around this acquisition as well, |
20 | especially from a patient need perspective. There's |
21 | clearly a very significant unmet need for new treatment |
22 | options in metastatic triple-negative breast cancer that |
23 | improves survival for patients. Later line |
24 | triple-negative breast cancer currently primarily |
25 | treated with conventional chemotherapy and outcomes are |
Page 10
1 | poor as Merdad was mentioning. The remarkable top line |
2 | results from the ASCENT study in third-line patients has |
3 | understandably generated significant enthusiasm by both |
4 | physicians and patients. Full results will be shared |
5 | later this week at ESMO and this enthusiasm should only |
6 | continue. |
7 | Trodelvy's strong efficacy profile has led |
8 | to early adoption in both academic and community |
9 | settings since its commercial launch in late April with |
10 | 20 million net sales in the first two months of launch. |
11 | Its rapid launch uptake in the challenging environment |
12 | of a pandemic speaks to the strong science and the |
13 | flawless execution of the team. The field force has |
14 | been very focussed in its early efforts on the top 150 |
15 | breast cancer accounts in the U.S. in which penetration |
16 | has exceeded 80 percent and continues to grow. |
17 | We really look forward to supporting and |
18 | expanding the successful launch in triple-negative |
19 | breast cancer, preparing for an imminent launch in |
20 | Europe and maximizing Trodelvy's potential across |
21 | multiple solid tumor types and establishing a global |
22 | footprint. So with that, I'll turn it over to Andy for |
23 | the quote. |
24 | MR. DICKINSON: Thank you, Johanna. I will |
25 | briefly review the financial terms of the transaction |
Page 11
1 | and then we will turn to questions. As indicated in our |
2 | joint press release, Gilead and Immunomedics have |
3 | entered into an agreement pursuant to which Gilead will |
4 | acquire Immunomedics for $88 per share for a total |
5 | purchase price of approximately $21 billion. We expect |
6 | to commence a tender offer to acquire all of the |
7 | outstanding shares of Immunomedics' common stock in the |
8 | next two weeks. |
9 | The tender offer is not subject to a |
10 | financing condition, and we expect to fund the |
11 | acquisition with approximately 15 billion of existing |
12 | cash and approximately 6 billion in newly-issued debt. |
13 | We expect to retain an investment-grade credit rating |
14 | following the transaction. The transaction does not |
15 | alter our stated capital allocation strategy, including |
16 | our commitment to further develop our internal and |
17 | external pipeline, as well as our commitment to maintain |
18 | and grow our dividend over time. |
19 | Once completed, we expect that the |
20 | acquisition will substantially accelerate our revenue |
21 | growth through the mid-2030s. We also expect that the |
22 | transaction will be neutral to accretive to our non-GAAP |
23 | EPS in 2023 and significantly accretive thereafter. |
24 | Finally, we plan to update our financial |
25 | guidance after the closing, which we expect to occur in |
Page 12
1 the fourth quarter subject to regulatory approvals and
2 | customary closing conditions. | We will now open the call |
3 | to questions. |
4 | MALE SPEAKER: Thank you, sir. As a |
5 | reminder, to ask a question you would need to press star |
6 | 1 on your telephone. To withdraw your question, please |
7 | press | the | pound key. | Please standby while we compile |
8 | the Q | and | A roster. | |
9 | I show | our first question comes from the |
10 | line of Geoffrey Porges from SVB Leerink. Please go |
11 | ahead. |
12 | DR. PORGES: Thank you very much and |
13 | congratulations on the transaction. A couple of |
14 | questions for you, Andy. Andy, looks as though |
15 | consensus has full -- Trodelvy is heading towards |
16 | $4 billion. What revenue do you think is sort of a |
17 | good, break-even hurdle for the 21 billion purchase |
18 | price? And then could you advise us on what sort of |
19 | cost of capital you think is appropriate for a |
20 | transaction such as this with an approved product in the |
21 | current economic climate? Obviously, you have terrific |
22 | access to the capital markets. And then, lastly, |
23 | Merdad, could you talk a little bit more about the |
24 | combination opportunities? For example, the PD-1, are |
25 | you going to study it within the PD-1 from Arcus, and |
Page 13
1 | then do you have plans to study it in combination with |
2 | the CDK-46, and then have you had any discussions about |
3 | our particular candidates? Thanks. |
4 | MR. DICKINSON: Thanks, Geoff. As for the |
5 | revenue opportunity, you know, we agree that this is a |
6 | very substantial opportunity across, not only breast |
7 | cancer, but other solid tumor indications over time. |
8 | We're not providing specific revenue guidance as you |
9 | would expect, but you know, we see a very significant |
10 | opportunity in a number of ways when, as you heard from |
11 | Dan earlier, and we're happy to talk about in greater |
12 | detail. |
13 | On the cost of capital, we look at the cost |
14 | of capital in the same way as other companies of our |
15 | size. We look -- in a transaction of this nature, we |
16 | look at the transaction across a range of discount |
17 | rates, we look at our cost of capital, which you know, |
18 | hovers somewhere around 6 percent or below today. But |
19 | you know, our hurdle rate is higher than that, Geoff, |
20 | even though we don't provide specific guidance. |
21 | We also look at transactions, as you know, |
22 | based on the target assets weighted average cost of |
23 | capital. In looking at it in any way, you know, we get |
24 | to a place on intrinsic value where we're very |
25 | comfortable with this acquisition and believe that it |
Page 14
1 | will deliver substantial value for our shareholders over |
2 | time. |
3 | DR. PORGES: Thank you. |
4 | MR. DICKINSON: with that, maybe I'll hand |
5 | it off of Merdad. |
6 | DR. PARSEY: Yeah, Geoffrey. Thank you for |
7 | the question. And you're right, I think we do believe |
8 | that there's a lot of potential here for combination. |
9 | And I would think about combinations very broadly here. |
10 | Depending on the tumor type and the stage of therapy, I |
11 | think it's important that to note that that would |
12 | probably entail different sorts of combinations in those |
13 | settings. |
14 | Having said that, the data for combinations |
15 | with checkpoint inhibitors as well as for PARP |
16 | inhibitors are very interesting to us and certainly |
17 | having ZIM (phonetic) provides us a lot more flexibility |
18 | in terms of designing studies we can to look at |
19 | combinations across tumor types. So without a doubt, |
20 | we'll be looking at that. Again, a lot of that is going |
21 | to be driven by the tolerability profile that Trodelvy, |
22 | and we think that really lends itself to those sorts of |
23 | combinations, which is something we're excited about. |
24 | DR. PORGES: Right. Thanks very much. |
25 | MALE SPEAKER: Thank you. I show our next |
1 | question comes from Michael Yi (phonetic), from |
2 | Jeffrey's. Please go ahead. |
Page 15
3 | MR. YI: Hey, thanks and good afternoon. |
4 | Two questions. Can you maybe talk about your |
5 | assumptions or thinking or confidence levels around the |
6 | major indications that you ascribe in your thinking |
7 | about the valuation in the 21 billion; breast, bladder, |
8 | et cetera, et cetera? |
9 | And then related to that, you made a |
10 | comment about having seen additional data that the |
11 | street hasn't seen. So could you just talk to that |
12 | particularly as it relates to that HR positive phase 3 |
13 | breast cancer study and anything in the basket study? |
14 | Thank you so much. |
15 | MR. O'DAY: Yeah, Michael, why don't I |
16 | start and then I'll quickly turn it over to Merdad. But |
17 | I think, you know, in terms of the assumptions around |
18 | the major indications, and Merdad can color this a |
19 | little bit, I think it also gets back to the previous |
20 | question around, you know, the multiple opportunity to |
21 | have benefit for patients and also for revenue and |
22 | shareholders. Clearly, the near term opportunities -- |
23 | well, the opportunity in our hand today is, of course, |
24 | triple-negative breast cancer and the ability to move up |
25 | in lines of therapy there, but then closely behind that |
1 | is both bladder cancer data that you'll see at ESMO, and |
2 | then also the hormone receptor positive data that, you |
3 | know, is underway right now. And then one step maybe |
4 | slightly, you know, at the next step up from those three |
5 | indications is lung cancer and then beyond. |
6 | So I would just say that, you know, in |
7 | terms of our assumption base, there's obviously lots of |
8 | assumptions that you can get into by looking at the |
9 | early data and try to project that to the later data, |
10 | but we also know in oncology that particularly sometimes |
11 | those play out and sometimes those don't play out. So I |
12 | just want to make sure that you understand that we -- |
13 | we've looked at this in binary scenarios by indication |
14 | as we looked at intrinsic value as well and, obviously, |
15 | moving up to earlier lines of therapy. |
16 | I'll let Merdad speak a little bit more |
17 | about -- you can fill in on the assumption side if you |
18 | like, Merdad, or also the additional data. |
19 | DR. PARSEY: Yeah, Michael. You know, I |
20 | think Dan pretty much said everything I was going to |
21 | say. I think our -- obviously triple-negative being |
22 | with the accelerated approval is at the highest part of |
23 | our confidence level. I think breast cancer more |
24 | broadly speaking also as we see the data, we're very |
25 | excited about and I think we have -- could really impact |
1 | some patient care there. And so those are at our |
2 | highest list. I think for the urothelial cancer as |
Page 17
3 | well, we've seen really promising data, and as you get |
4 | farther down into like non-small cell, there's less |
5 | data, of course, and -- but we're impressed by all of it |
6 | across the board and we think there's promise there. |
7 | I can't speak obviously to the embargo data |
8 | that will show at ESMO this week, but I think as you see |
9 | those data and you see the combination data as well, I |
10 | think you'll start to see sort of where our excitement |
11 | comes from in terms of building this, the base for this |
12 | molecule. |
13 | MR. O'DAY: And Michael, not to be |
14 | specific, but obviously we've seen data beyond the data |
15 | that we've presented at ESMO that maybe presented at |
16 | future conferences as well. And as you can imagine, we |
17 | can't tip our hat to that at this stage, but you know, |
18 | we had a really good thorough look at this. It's |
19 | important to note that we started this partnering |
20 | process almost six months ago and, of course, we've |
21 | developed a really nice relationship with Immunomedics |
22 | over that period of time. And data has become available |
23 | over those six months that we've been able to be exposed |
24 | to under diligence and confidentiality. And that's |
25 | only, you know, increased our enthusiasm around the |
1 | potential here. |
Page 18
2 | MR. YI: Yeah, that's what I mean, thank |
3 | you. |
4 | MALE SPEAKER: Thank you. Our next |
5 | question comes from the line of Evan Seigerman from |
6 | Credit Suisse. Please go ahead. |
7 | MR. SEIGERMAN: Hi all. Thank you so much |
8 | for taking my question and congrats on the transaction. |
9 | So with this relatively large scale transaction, Andy, |
10 | could you kind of quantify how much more capacity you |
11 | have for additional business development, and can you |
12 | specify to whether or not this one's on your radar, |
13 | ahead or after the CRL for filgotinib? I'm just trying |
14 | to get a sense as to how this fits in strategically. |
15 | Thank you. |
16 | MR. O'DAY: Yeah, let me just take the |
17 | second question while Andy, you take the first. I think |
18 | it's really important to note that there was no |
19 | connection between this and the CRL with filgotinib. |
20 | But let me first address this CRL with filgotinib by |
21 | saying that, you know, clearly, as often happens you see |
22 | regulatory authorities in different countries taking |
23 | different accessions (phonetic) on filgotinib and CRL |
24 | and, you know, we're fully committed to continuing to |
25 | explore and understand better the CRL with FDA and see |
1 | where that leads us, but that has nothing to do, of |
Page 19
2 | course, with our desire to expand our transformational |
3 | medicines either, you know, continuing in inflammatory |
4 | (unintelligible) virology nor oncology. |
5 | So this was part of our broader objective |
6 | to deliver more than 10 transformative medicines over |
7 | the next 10 years. And what started, as I said, well |
8 | before we actually knew the regulatory cost of |
9 | filgotinib, but was started the discussions -- well, we |
10 | knew of this agent, of course, quite long ago. And the |
11 | discussions started, as I said, many months ago as well. |
12 | Andy, over to you for the deck capacity. |
13 | MR. DICKINSON: Great. Hey, Evan, thanks |
14 | for joining the call. You know, prior to the |
15 | transaction if you look at most analyst assumptions |
16 | which were generally consistent with our internal model, |
17 | we had well over $40 billion of total fire power with |
18 | the cash and the financing capacity that we had. So |
19 | we're using a reasonable chunk of that here, but we have |
20 | significant fire power going forward. I mean, the other |
21 | thing I would highlight is you don't do a $21 billion |
22 | deal every year, right? |
23 | So we absolutely have the capacity to |
24 | continue to do ordinary course business development |
25 | transactions, transactions similar to the Forty Seven |
1 | transaction. We have plenty of cash to support and grow |
2 | our dividend over time which is really important to us |
3 | as well. So we're very comfortable with where we are on |
4 | a pro forma basis after closing of this transaction. |
5 | Thank you. |
6 | MR. SEIGERMAN: Thank you. |
7 | MALE SPEAKER: Thank you. Our next |
8 | question comes from Robin Conoscos (phonetic) from |
9 | Truist. Please go ahead. |
10 | MS. AHN: Hi, and good afternoon. This is |
11 | Nicole Ahn (phonetic) for Robin form Truist. And |
12 | congrats on the deal as well and thanks for taking our |
13 | question. So on the slide deck on the guidance and the |
14 | accretive impact, is this assuming filgotinib is |
15 | factored in or without it? And I apologize if this has |
16 | already been mentioned. |
17 | MR. DICKINSON: Yeah the EPS -- you know, |
18 | being EPS neutral is looking at a pro forma basis with |
19 | the impact of this, right. So it's separate and apart |
20 | from filgotinib, which we'll provide updated thoughts on |
21 | where we -- where we see filgotinib going in the coming |
22 | months and quarters as we finish our discussions with |
23 | our partner and with regulators. So on a standalone |
24 | basis as you fold this in, we expect this to be neutral |
25 | to accretive in 2023 and significantly accretive |
1 | thereafter. | |
2 | MS. AHN: Okay, great, thanks so much. | |
3 | MR. DICKINSON: Thank you. | |
4 | MALE SPEAKER: Thank you. Our next |
5 | question comes from Alethia Young from Cantor |
6 | Fitzgerald. Please go ahead. |
7 | MS. YOUNG: Hey guys, thanks for taking my |
8 | question. Congrats on the deal. I guess, the question |
9 | for me is obviously this is a pretty large scale deal |
10 | that we've seen in the history of Gilead. So I guess |
11 | I'm just trying to understand, are you making a core |
12 | investment in hematology, oncology -- sorry, my dog |
13 | likes your deal, too -- and you know, how (inaudible) |
14 | five years from now -- |
15 | MR. O'DAY: Good taste, good taste that |
16 | dog. Alethia, can you repeat the end of your question? |
17 | MS. YOUNG: Just obviously looking at Gil' |
18 | five years from now, is hematology oncology accompanied |
19 | with HIV, or are you going to diversify beyond that, you |
20 | think? |
21 | MR. O'DAY: Oh, okay. Look, I think you |
22 | know, it's really important that you understand that |
23 | we're following our strategy which has two elements to |
24 | it as its core. Number one, you know, we believe that |
25 | we want to continue building on our scientific base we |
1 | have in the area of virology and also inflammatory |
Page 22
2 | disorders as immunomodulatory disorders and that lends |
3 | itself to cancer and inflammation. And I think we'll |
4 | follow the science. In other words, what's most |
5 | important to us is that we can make a transformational |
6 | difference of | patients and that's really what we're |
7 | driven by. | |
8 | So personally, I think, you know, that the | |
9 | three pillars | we have in our business, you know, we're |
10 | certainly not -- let me just say, we're certainly not |
11 | done with HIV, right? I mean, we have more to do there, |
12 | we're excited about the capsid inhibitor, we have lots |
13 | of research activities going on there in virology and |
14 | beyond that. Of course, you've seen the benefit of that |
15 | for emerging viruses with the medicine like remdesivir. |
16 | Likewise, in inflammatory disorders we have a large |
17 | investment both in house with our partners like |
18 | Galapagos that we're firmly committed to. |
19 | And then finally now, this gives us a third |
20 | leg in oncology and hematology. It'd be hard for me to |
21 | imagine or to project in five years or ten years, you |
22 | know, the size of any one of those pillars, because that |
23 | will be driven by the uncertainties of science and how |
24 | we're going after the unmet medical needs. But it's |
25 | really important that you know that we're firmly |
1 | committed to all three of those areas, which is why the |
2 | previous question on acquisition capacity and our |
3 | ability to continue to flush out those areas as the |
4 | science evolves. |
5 | It's important we'll remain focussed on |
6 | that and very importantly, bringing in the best talent |
7 | from outside into our company to be able to make those |
8 | decisions. And maybe I'll just finalize on that talent |
9 | equation, because in addition to, of course, the great |
10 | colleagues we have at Kite and Gilead in oncology, |
11 | welcoming the Immunomedics talent to our family and the |
12 | opportunity that Trodelvy brings, I think that also |
13 | becomes a talent attraction and a talent magnet for |
14 | people that want to really make a difference for cancer |
15 | patients. |
16 | They want to come to companies that have |
17 | unmarked products that are near term, plus highly |
18 | innovative things that are earlier term. And with this |
19 | portfolio I think that gets us a great human capital |
20 | attraction as well, but all three areas we need that |
21 | human capital in. |
22 | MS. YOUNG: Awesome, thank you. Congrats. |
23 | MR. O'DAY: Thanks, Alethia. |
24 | MALE SPEAKER: Thank you. Our next |
25 | question comes from the line of Carter Gould from |
1 | Barclay's. Please go ahead. |
Page 24
2 | MR. GOULD: Good afternoon, guys. Congrats |
3 | on the deal. I guess two -- I guess, first off, can you |
4 | just comment for, I guess, first around sort of the |
5 | level of comfort with the competitive environment and |
6 | your internal assumptions around how you see that sort |
7 | of playing out? Obviously, Immunomedics has (inaudible) |
8 | first-mover advantage but there our competitors there. |
9 | And then secondly, just now, how you view sort of the |
10 | split in terms of R&D focus between hem-onc and solid |
11 | tumors and if this is closer to serve your target |
12 | balance? Any color there would be appreciated. Thank |
13 | you. |
14 | MR. O'DAY: So maybe I'll start on the |
15 | second question and turn the first question over to |
16 | Merdad. And Merdad, you can also -- but I think on this |
17 | balance between investment and hem-onc versus solid |
18 | tumors, again, you should hear directly from Merdad on |
19 | this, but I think the point is we'll follow the science. |
20 | So I think wherever we think we could have the biggest |
21 | impact on patients is where our investments will go. |
22 | And Merdad is putting together, you know, a portfolio |
23 | group and committee and decisionmaking process of Gilead |
24 | that's complimentary to the one at Kite that allows us |
25 | to kind of make those investment decisions based upon |
1 | data. And so you know, I think it'd be hard to predict |
2 | what the split will be between those two. |
3 | But of course, we've been heavier on |
4 | hematology side because of Kite and the recent |
5 | acquisition of Forty Seven in terms of late stage. And |
6 | now, this kind of fast forwards it for solid tumors, so |
7 | it certainly brings forward the immediate opportunity in |
8 | a much bigger way for solid tumors which we're excited |
9 | about. Merdad? |
10 | DR. PARSEY: Yeah. The only thing I'd add |
11 | to that is, you know, I think to embellish on what Dan |
12 | said, you know, we are focussed on making an impact and |
13 | having an impact on patients. And rather than sort of |
14 | saying we want a certain percent team or a certain |
15 | percent solid tumor, as Dan said, we'll follow the |
16 | science and go after the place where we think we can |
17 | have the biggest impact. So we don't have a quota we're |
18 | trying to fill or anything like that. |
19 | In terms of competition, I think it's safe |
20 | to assume that in oncology there's always competition |
21 | and, you know, we think about both the in-class and the |
22 | broader competitive space within each of the therapeutic |
23 | areas that we're interested in. Certainly for the in- |
24 | class competition we're excited that we're out ahead, |
25 | you know, and we're farther along and obviously approved |
1 | with the accelerated approval. I don't think we can be |
2 | complacent about that and we'll have to continue to |
3 | explore the molecule as aggressively as possible to show |
4 | the benefit of Trodelvy in various patient populations. |
5 | And then, you know, more broadly in |
6 | different tumor types, you know, I think what we can |
7 | bring is a orthogonal approach to some of the other |
8 | approaches people are taking in those tumors and |
9 | hopefully add to them and hopefully move up in lines of |
10 | therapy so that we can look at unique combinations as |
11 | we've mentioned, things like PARP inhibitors in some |
12 | tumor types, maybe IO in other tumor types. And I think |
13 | that allows us to move up into earlier lines of therapy. |
14 | So we'll be looking at that very broadly in order to |
15 | maintain our competitive edge, both in class and outside |
16 | of class. |
17 | MR. GOULD: Thank you. |
18 | MALE SPEAKER: Thank you. Our next |
19 | question comes from Phil Nadeau from Cowen and Company. |
20 | MR. NADEAU: Good afternoon. Let me add my |
21 | congratulations on the deal. Couple questions from me |
22 | on the upcoming data events. So it sounds like you've |
23 | been able to see and fully review the urothelial data |
24 | that we're going to see next weekend at ESMO. I'm |
25 | curious, what does your due diligence say about the |
1 | ability of that single-arm face to support an FDA filing |
2 | and approval? |
3 | And then second, there has been some |
4 | controversy among Immunomedics investors about the |
5 | timing of the interim analysis in the ER positive/HER2 |
6 | negative breast cancer study. What does your diligence |
7 | say about the timing of that analysis, and certainly, do |
8 | you think that that analysis will support an FDA filing? |
9 | DR. PARSEY: Andy, do you want me to take |
10 | that? |
11 | MR. DICKINSON: Sure, yes. |
12 | DR. PARSEY: Yeah, okay, happy to take it. |
13 | So we do think that, obviously, we're optimistic about |
14 | the ability to file triple-negative this year. When we |
15 | look forward in triple-negative we think that we'll be |
16 | able to continue to expand in the EU. And then we are |
17 | optimistic about our chances to be filing for urothelial |
18 | hopefully for accelerated approval based on the data as |
19 | we think about 2021 and beyond. |
20 | After that, it obviously becomes a little |
21 | bit more grey, but we do hope for, you know, as the data |
22 | emerged that we do see the possibility of multiple |
23 | additional sBLAs coming up in the next few years. |
24 | MR. O'DAY: And the other question was the |
25 | timing of the in interim on the arm receptor positive. |
1 | Merdad? |
2 | DR. PARSEY: Oh, yeah, sorry. And that |
Page 28
3 | should be next year. That should be next year. We're |
4 | looking at sort of the second half of next year for |
5 | those data. Sorry. |
6 | MR. NADEAU: And do you think that'll |
7 | support an FDA filing? |
8 | DR. PARSEY: It's possible. I think we're |
9 | kind of thinking about that's -- the potential for that |
10 | would be obviously in 2022 and beyond, depending on the |
11 | outcome. That's possible that we could have that, but |
12 | obviously, we haven't seen those interim data, right? |
13 | So that's speculation. But hopefully, we'll do the |
14 | interim and if it does support it we would go for a |
15 | filing in 2022. |
16 |
17 questions and congrats again 18 MR. DICKINSON: 19 MALE SPEAKER: |
MR. NADEAU: Great. Thanks for taking my on the deal.
Thanks, Phil.
Thank you. Our next
20 | question comes from Brian Abrahams from RBC Capital |
21 | Markets. Please go ahead. |
22 | MR. ABRAHAMS: Hey guys, thanks for taking |
23 | my questions and my congrats on the deal as well. How |
24 | are you thinking about the launch ramp for Trodelvy and |
25 | the potential for commercial synergies there? And then |
1 | can you talk about the long-term leveragability of their |
2 | ADC technology? Thanks. |
3 | MR. O'DAY: Johanna, do you want to take |
4 | the launch one? |
5 | MS. MERCIER: Yep, sure. So Brian, I think |
6 | what we've seen so far is, obviously, the first two |
7 | months that Immunomedics have spoken to about in their |
8 | earnings call this summer, and obviously a very strong |
9 | start, we've also seen some pretty powerful data around |
10 | not only the awareness of Trodelvy in the marketplace |
11 | with oncologist that treat breast cancer, but also their |
12 | intent to prescribe. And I think what we're seeing is a |
13 | really nice ramp up and that's really kudos to the |
14 | Immunomedics team for making sure that happens in such a |
15 | quick time, both from a physician education standpoint |
16 | but also from an access standpoint in making sure that |
17 | there's no barriers for patients. |
18 | So I think they're off to a very strong |
19 | start. I think the opportunity is, obviously, to |
20 | continue to grow that and potentially expand even the |
21 | footprint as we think about moving it forward, not only |
22 | in triple-negative breast cancer but other areas as |
23 | well. So I think we're excited about that, let alone |
24 | the fact that, you know, the intent is to file a |
25 | submission in Europe early next year, and obviously |
1 | follow up very quickly in Europe and beyond that to |
Page 30
2 | really maximize the opportunity with a global footprint |
3 | that Gilead already has. So I do think that the |
4 | opportunity from a launch uptake over the next 18 to 24 |
5 | months are quite large. |
6 | MR. O'DAY: Thanks. And long-term |
7 | potential on the ADC, I mean, Merdad, of course, you may |
8 | have some insights there. |
9 | DR. PARSEY: You know, I think that |
10 | certainly what's -- I think a lot of people have been |
11 | struggling with ADCs for a long time and what we're |
12 | excited about, what we're seeing on the therapeutic |
13 | potential here of this platform, so it's definitely |
14 | something that we will consider as we get into that. |
15 | Certainly, the ability to deliver the payload here with |
16 | this particularly linker is promising in |
17 | triple-negative, so we have to think about what other |
18 | antibodies and antigens we can go after to try to expand |
19 | the utility. So we'll definitely be considering those |
20 | going forward. |
21 | MR. ABRAHAMS: Got it. Thanks again. |
22 | MR. O'DAY: Thanks, Brian. |
23 | MALE SPEAKER: Thank you. Our next |
24 | question comes from Matthew Harrison from Morgan |
25 | Stanley. Please go ahead. |
1 | MR. HARRISON: Great, good afternoon, |
2 | thanks for taking the question. I guess two for me. |
3 | One, can you just talk about your view on competitive |
Page 31
4 | differentiation versus passive. And then secondly, just |
5 | from a strategic standpoint, I think previously you've |
6 | talked about for oncology pursuing what I call more IO |
7 | adjacencies in IO type products, and it seems more like |
8 | a more traditional solid tumor product, so should we |
9 | think about you expanding the breadth of the kinds of |
10 | product you'd like to bring in? Thanks. |
11 | MR. O'DAY: Yeah, let me -- thanks Matthew |
12 | for the thoughtful question and I'll let Merdad speak |
13 | about your first one on the competitive differentiation |
14 | of padsil (phonetic). But I think on the second one, |
15 | and I'll give you my viewpoint and Merdad as well can |
16 | give you his. I think, you know, of course, we continue |
17 | to remain interested on the cutting edge aspect of |
18 | oncology and a great deal that is immuno-oncology today |
19 | which has been our focus based upon, you know, some of |
20 | our scientific background in immunomodulation, which |
21 | adds some links back into virology and other scientific |
22 | foundations we have in the company. |
23 | Having said that, we've always said that we |
24 | would remain opportunistic on adjacencies. And I think |
25 | this is very connected mechanism versus IO in our |
1 | opinion. Scientifically, of course, it's targeted |
2 | towards TROP-2 expression, it's broadly applicable to |
Page 32
3 | solid tumors, and because of its profile, we think it's |
4 | combinable, of course, not just with IO but could very |
5 | well be, you know, one of the biggest opportunities |
6 | could be combinability with IO. |
7 | So I think it really fits into our |
8 | strategy, number one, but number two to our point, you |
9 | know, it could have us alter our strategy, right? The |
10 | strategy should never be set in stone, and a lot of our |
11 | experiences, many of us have decades of experience in |
12 | oncology strategy, one thing you know is you've gotta |
13 | stay nimble and ready to kind of move and rotate. |
14 | It reminds me of the old ADC days that |
15 | Genetech and Roshrem (phonetic) we had, you know, dozens |
16 | of ADCs that we thought after concile were just going to |
17 | come pouring out. And the story there was that it |
18 | wasn't quite as easy to get an antibody linker and toxin |
19 | to be -- to hit that sweet spot of efficacy and safety. |
20 | And that's why we're so impressed by the way -- what |
21 | Immunomedics has done with Trodelvy. |
22 | So I think the bottom line is that, yes, |
23 | we'll continue to focus on IO, yes we have great |
24 | modalities and housed some cell therapy and non-cell |
25 | therapy and those are building. And I think, you know, |
1 | this may have us rethink how we are inclusive in |
2 | oncology strategy, you know, of other modalities and |
3 | other mechanisms. So stay tuned on that. I mean, |
4 | clearly with this being such a potential foundational |
Page 33
5 | molecule for lots of tumor types, not only within Gilead |
6 | but also outside of Gilead, you know, we'll continue to |
7 | look for partnership opportunities. And certainly, |
8 | Immunomedics already has, you know, a line of folks that |
9 | are interested in looking at combinability of their |
10 | agents with Trodelvy and nothing on that will change as |
11 | we go into the next phase of Trodelvy's growth. |
12 | Merdad, please. |
13 | DR. PARSEY: Yeah, yeah. And ongoing -- |
14 | just to finish that point, you know, and emphasize is |
15 | ongoing combination trials with molecules from other |
16 | companies. And we'll continue to do that and look to |
17 | those readouts because I think they'll be very |
18 | important. As far as the comparison that |
19 | (unintelligible), I think certainly the data continued |
20 | to evolve. What we are excited about is that Trodelvy |
21 | brings a very different safety profile as well as |
22 | efficacy, right, so I think it's important to look at |
23 | both sides of that. |
24 | And so we're fairly confident as the data |
25 | mature that there will be a role for Trodelvy that will |
Page 34
1 | be complimentary to that for the competitor molecules in |
2 | this space primarily because of the difference in |
3 | tolerability. I think there's -- it's a very different |
4 | profile and I think in this -- there's specific things |
5 | about some of the more frail patients and urothelial |
6 | cancer, that difference in the adverse event profile may |
7 | afford patients a really great choice in terms of |
8 | treatment options there. So we think there's a |
9 | differentiating effect there from the safety standpoint |
10 | as well as efficacy. |
11 | MALE SPEAKER: Thank you. I show our next |
12 | question comes from Terence Flynn from Goldman Sachs. |
13 | Please go ahead. |
14 | MR. FLYNN: Hi. Thanks for taking the |
15 | questions and appreciate all the color. Just had a few. |
16 | Was wondering what you guys were assuming for Trodelvy |
17 | IP particularly given it's an ADC that goes out longer. |
18 | And then on the sales force side, can you just provide |
19 | any detail there in terms of the size of the current |
20 | sales force, plans for Europe, and then any leverage |
21 | opportunity with your current sales force? And then on |
22 | the drug pricing side, you know, obviously, there's some |
23 | uncertainty into the U.S. election, just wondering as |
24 | you thought about your models here, with respect to |
25 | longer-term pricing dynamics anything of note, or did |
1 | you already factor in a pretty conservative pricing |
Page 35
2 | outlook? Would just be curious to get some color there. |
3 | Thank you. |
4 | MR. O'DAY: Andy, do you want to do the IP |
5 | and then Johanna, you can do some of the sales force and |
6 | a bit of pricing. I could also do some pricing, too, if |
7 | you like. |
8 | MR. DICKSON: Yeah, I'd be happy to start. |
9 | I think -- Terence, thanks for the questions. At a high |
10 | level, I think we're not providing specific guidance. |
11 | What we'd say is we're very comfortable with the IP |
12 | estate well into the 2030s. Obviously, anti body drug |
13 | conjugates are unique and have multiple layers of patent |
14 | estates, but we're very comfortable that this asset will |
15 | have IP protection well into the 2030s. Johanna? |
16 | MS. MERCIER: Yeah, thanks, Andy. And so |
17 | maybe going on first to the field force coverage that |
18 | you're referring to, I think two things. I think |
19 | Immunomedics has a good coverage today across the United |
20 | States. I think there might be some opportunities |
21 | potentially expand and even leverage some of the work |
22 | that's going on with Kite as well, since Kite is very |
23 | well established in the academic setting. And so the |
24 | interplay between academia and community is going to be |
25 | very important. And right now, the split is about |
1 | 70/30; 70 community, 30 academic is where they're |
Page 36
2 | looking at their current business. And I think there's |
3 | probably an opportunity to continue to evolve that. |
4 | I think to your question to Europe, |
5 | obviously, that's something we're going to take on |
6 | pretty quickly. I do think we have previous models of |
7 | what an oncology footprint would look like in Europe, |
8 | and it's a little bit of a different setting than in the |
9 | U.S., but I think we feel confident that we can ramp it |
10 | up pretty quickly over the next few months as we look at |
11 | the model and the timing, of course, both for regulatory |
12 | approval, but as you know, reimbursement takes a little |
13 | bit longer in many markets. |
14 | And then the last piece of the puzzle about |
15 | drug pricing, obviously, this is a market-approved |
16 | product, so the U.S. pricing assumptions were a little |
17 | bit easier and, of course, as we look at the outlook, |
18 | we've been just as conservative about our outlook as we |
19 | look at our own product portfolio and applied similar |
20 | assumptions, similar within the U.S. and also outside of |
21 | the U.S. as we think about Europe, for example. |
22 | Hopefully that addresses -- I don't know, |
23 | Dan do you want to add anything to that? |
24 | MR. O'DAY: No, not really, Terence, I |
25 | mean, I think that's exactly what I wanted to say is |
1 | that we're always quite conservative when we do these |
Page 37
2 | types of modelings around both the continued decline in |
3 | Europe and somewhat stable in the United States. Having |
4 | said that, have we factored it in every scenario in the |
5 | U.S. for any of our products? No. I remain convinced |
6 | that, A, we need reform on drug pricing in the United |
7 | States. And B, we have to make sure that patients' out- |
8 | of-pocket costs are the things we target, and that we |
9 | most importantly, see reward innovation. |
10 | And I remain convinced that we'll get to |
11 | those types of policies. We've been rolling our sleeves |
12 | up and we'll get there. But for medicines like this |
13 | that have such a dramatic impact I think these are |
14 | largely, you know, not the medicines and the focus, and |
15 | I think one has to have a high differentiation on any |
16 | environment that we're going to go into around the world |
17 | in terms of drug pricing. And I, for one, really like |
18 | the profile of this medicine as we approach whatever |
19 | reforms may happen, not only in the United States, but |
20 | everywhere in the world, because this really does have a |
21 | very significant impact on patients. So that's -- the |
22 | most important thing is to keep the bar high on |
23 | innovation. |
24 | MR. DICKINSON: Terence, one more point on |
25 | your question. The regulatory and statutory exclusivity |
1 | in the U.S. is also important as you think about the |
Page 38
2 | exclusivity period around this antibodies in particular |
3 | in the U.S. |
4 | MALE SPEAKER: Thank you. I show our next |
5 | question comes from the line of Jim Berkanoff (phonetic) |
6 | from Wells Fargo. Please go ahead. |
7 | MR. BERKANOFF: (Inaudible) Thanks for |
8 | taking our questions and congratulations on the deal. |
9 | Our first question is on manufacturing of the antibody. |
10 | Obviously, Immunomedics is planning on using Samsung |
11 | Biologics for expanded commercial supply. What is your |
12 | strategy to maintain a tight constant grips on the |
13 | antibody? And a second question is whether |
14 | (unintelligible) interest in the Koch Organization, how |
15 | you feel about ADC, the ADC platform and cell therapy as |
16 | part of an integrated option for a specific target. |
17 | Thank you. |
18 | MR. O'DAY: Thanks. Maybe Andy and Merdad? |
19 | MR. DICKINSON: Yeah, I'll start on the |
20 | manufacturing side. As you'd expect, I mean, there's a |
21 | lot of history here on the manufacturing side with our |
22 | CMC team has spent a lot of time with the Immunomedics |
23 | team looking at this. It's a relatively complex |
24 | manufacturing network relative to others given that you |
25 | have either from parties toxin (phonetic) and the linker |
1 | and the antibody and then pulling it all together. |
2 | We're very comfortable with what they've done. They |
3 | have a great team, we think they've done a great job. |
4 | We're comfortable with our ability to scale it up. |
Page 39
5 | Obviously getting Samsung in place was an important step |
6 | for them as well, it gives us a lot of comfort. |
7 | So we -- you know, the cost of goods here |
8 | specifically to your question, are entirely in line with |
9 | the rest of our portfolio at scale including, you know, |
10 | standard kind of antibody and small molecule cost of |
11 | goods. So there's nothing unique here other than you |
12 | know with slightly different than your standard |
13 | antibody, but that scale, we see every opportunity to |
14 | get to a really attractive cost of goods. Merdad? |
15 | DR. PARSEY: Yeah, and what I would say in |
16 | terms of the cell therapy, potential cell therapy, we |
17 | are very much focussed I would say primarily on the |
18 | solid tumor area right now making sure that we keep our |
19 | eye focussed on being successful and our core |
20 | indications. Having said that, we always -- we're very |
21 | close with our colleagues at Kite and always look at |
22 | opportunities more broadly and will -- this would go |
23 | into that bucket of we certainly consider potential |
24 | synergies between cell therapy and TROP-2 targeted |
25 | therapy. |
1 | MALE SPEAKER: Thank you. Our next |
Page 40
2 | question comes from the line of Mohib Bencil (phonetic) |
3 | from Citi. Please go ahead. |
4 | MR. BENCIL: Great, thanks for taking my |
5 | question and congrats on the deal. Quick question. So |
6 | communications -- I mean the goal was to bring the |
7 | by-plane that some small (unintelligible) and this seems |
8 | a little bit bigger than that, we just wanted to get |
9 | your thoughts on what changed the thought process here |
10 | and had it anything to do with the filgotinib action by |
11 | that? Thank you. |
12 | MR. O'DAY: Hey, Mohib. Yeah, Dan O'Day |
13 | here. So the answer to the question is no, it had |
14 | nothing to do with filgotinib. And what I would say is |
15 | that, you know, I think this is very consistent with the |
16 | strategy we laid out when I came in about a year and a |
17 | half ago with the team here, which is, you know, to be |
18 | disciplined about our scientific areas of strength and |
19 | where we're going to play and where we're not going to |
20 | play. And then secondarily, to do that with small to |
21 | medium-sized bolt-on acquisitions. So I mean, given our |
22 | market cap and ability, I think this clearly falls |
23 | sweetly into the medium-sized bolt-on. It's |
24 | particularly important, you know, because it's derisked |
25 | from the standpoint of having, you know, on-market and |
1 | approval to regulatory so that's obviously why it |
Page 41
2 | becomes more of a mid-size bolt-on, but strategically as |
3 | we talked about before, very much in line with our |
4 | strategy. And I think you can expect us to do more of |
5 | this. |
6 | Now as Andy says, it's not every day we're |
7 | going to do a $20 billion acquisition. We do have |
8 | sufficient fire power still to put to work and we'll |
9 | keep the threshold high on innovation. |
10 | The other thing we'll do is we'll continue |
11 | to be creative in terms of transaction structure. I |
12 | think Andy and his team have been real creative about, |
13 | you know, finding ways to partner with companies that |
14 | allow each party to share the risk more fully until you |
15 | get data, particularly on the earlier stage compounds, |
16 | or some of the innovative type structures we've created |
17 | that are very long-term research based and development |
18 | based initiatives like we've done with Galapagos on a |
19 | very sizable basis or ARCAS recently on the oncology |
20 | basis. |
21 | So I think making sure that we continue to |
22 | pivot and have a really fit-for-purpose approach on our |
23 | strategy as we think about small, medium-sized |
24 | partnership acquisitions you'll continue to see us do |
25 | that. And that's -- I think that takes a lot of work, |
1 | it takes relationships, it takes knowledge, it takes |
2 | know how, but at the end of the day I think it's the |
Page 42
3 | best way to make sure that you're -- whatever, whoever |
4 | your partnering with are acquiring but the innovation |
5 | stays intact and complete, because at the end of the day |
6 | it's about people, it's about getting them motivated, |
7 | and different structures are required to get us there. |
8 | So this is -- this is a medium-sized and it's |
9 | transformational for our oncology business, but I think |
10 | what you've seen in the past you can continue to expect |
11 | to see in the future. |
12 | MR. BENCIL: Very helpful, thank you. |
13 | MALE SPEAKER: Thank you. Our last |
14 | question comes from the line of Umer Raffat from |
15 | Evercore. Please go ahead. |
16 | MR. RAFFAT: Hi guys, thank you for taking |
17 | my question. I have a few today, if I may, and I would |
18 | appreciate you bearing with me on these. First Dan, I |
19 | don't think anyone will question the quality of the |
20 | asset or the strength of clinical data for Trodelvy, but |
21 | the same asset with much of the same clinical data |
22 | across indications was trading at less than 20 percent |
23 | of the acquisition price during most of 2019. So how |
24 | should we think about that especially also from a |
25 | capital allocation perspective from Gilead, number one. |
Page 43
1 | Merdad, a couple for you. I'm curious what |
2 | do you think about Dychee's (phonetic), TROP-2 ADC, |
3 | especially since it only needs one infusion per cycle, |
4 | not two. And also, if you could speak to the response |
5 | rate and know or low TROP-2 expressors both in UC and HR |
6 | positive breast, and what percent (unintelligible) is |
7 | that? Thank you very much. |
8 | MR. O'DAY: Sure Umer, we always appreciate |
9 | your questions and happy to take them. So on the first |
10 | one, just to put your question into context and I think |
11 | it's not uncommon to see share prices drop when you have |
12 | remarkable clinical data, but in particularly in the ADC |
13 | space, given what I said before about, you know, the |
14 | halls of many companies and academic that have been |
15 | littered with ADC that didn't show their promise, you |
16 | know, it's not uncommon to be skeptical until you see |
17 | clinical data. |
18 | At the end of the day clinical data trumps |
19 | I think everything. And so, of course, we saw an |
20 | appreciation of the share price based upon the clinical |
21 | data that's been publically made available so far. And |
22 | then to remind you from what Andy said before, we look |
23 | at this intrinsic value basis, a premium can often get |
24 | confused and particularly in this one, I think the |
25 | premiums are conflated by the fact that we have |
Page 44
1 | information that the public doesn't have yet, given the |
2 | upcoming ESMO meeting that you'll see next week. And |
3 | clearly, you know, it's our assumption that the share |
4 | price of Immunomedics also would have appreciated as a |
5 | result of the ESMO data as well. |
6 | So you take that into account when you look |
7 | at the entirety of the premium, but all of that |
8 | fundamentally is based on the clinical data both in |
9 | triple-negative breast cancer and the early clinical |
10 | data other indications that we talk about on this call, |
11 | as well as some of the data that you'll see at ESMO |
12 | around the early combinability. So that's really where |
13 | the intrinsic value comes from and I'd much rather look |
14 | at from that than where the share price was trading six |
15 | months, nine months, 12 months ago. |
16 | Merdad? |
17 | DR. PARSEY: Yeah, I don't have -- in terms |
18 | of the TROP-2 expression and I'd say it's really early |
19 | days we -- I think we need to understand our |
20 | relationship better that Immunomedics medics team has |
21 | done a great job of looking at that. And I would say |
22 | you know, the early data really intriguing in terms of |
23 | the relationship between TROP-2 expression and response. |
24 | But it'll take a lot more data for us to identify a cut |
25 | point, what it looks like in different tumor types, what |
Page 45
1 | it looks like in various lines of therapy. So I'd say |
2 | it's really too early to draw too many conclusions |
3 | there, but we'll have to gather more data to look at |
4 | that. But certainly, I feel that it looks as though |
5 | that higher levels of TROP-2 expression certainly seem |
6 | to have better responses in the general sense. But |
7 | we'll have to see how that evolves over time. |
8 | And then in terms of comparison to |
9 | (unintelligible) again, as I said earlier, I think it's |
10 | hard to compare it, because they're at different stages |
11 | of development in different patient populations with |
12 | different background therapy. Having said that, one of |
13 | the things that we like about, obviously, the |
14 | Immunomedics molecule is not only its efficacy but also |
15 | its safety profile. And as you've seen with the |
16 | (unintelligible) molecule, they do see some interstitial |
17 | lung disease that develops, and we haven't seen any |
18 | evidence of that with the Immunomedics molecule. |
19 | A lot of caveats around that, but we're |
20 | heartened by the fact that the tolerability profile |
21 | molecules needs to be really good and allows us to think |
22 | about earlier lines of therapy and accommodations in |
23 | ways that I think, you know, other molecules it would be |
24 | harder to think about in that way. |
25 | Hope that helps. |
1 MR. RAFFAT: Thank you very much, guys.
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2 | MALE SPEAKER: Thank you. This includes |
3 | our Q-and-A session. At this time I'd like to send the |
4 | call back over to Mr. Douglas Maffei, Senior Director |
5 | Investor Relations for closing remarks. Please go |
6 | ahead. |
7 | MR. MAFFEI: Thank you, Dalim (phonetic), |
8 | and thank you all for joining us today. We appreciate |
9 | your continued interest in Gilead and the team here |
10 | looks forward to providing you with updates on our |
11 | future programs. |
12 | MALE SPEAKER: Ladies and gentlemen, this |
13 | concludes today's conference call. Thank you for |
14 | participating. You may now disconnect. |
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1 CERTIFICATION
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8 I, Carmel Martinez, TX CSR No. 8128, FPR No. 1065,
9 | do certify that I was authorized to and did listen to |
10 | and transcribe the foregoing recorded proceedings and |
11 | that the transcript is a true record to the best of my |
12 ability. 13
14 Dated this 14th day of September, 2020. 15
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19 | Carmel Martinez, |
20 | TX CSR No. 8128 |
21 | FL FPR No. 1065 |
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FORWARD-LOOKING STATEMENTS
This communication contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, related to Gilead, Immunomedics and the acquisition of Immunomedics by Gilead that are subject to risks, uncertainties and other factors. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including all statements regarding the intent, belief or current expectation of the companies’ and members of their senior management team. Forward-looking statements include, without limitation, statements regarding the business combination and related matters, prospective performance and opportunities, post-closing operations and the outlook for the companies’ businesses, including, without limitation, the ability of Gilead to advance Immunomedics’ product pipeline and successfully commercialize Trodelvy; expectations for achieving full U.S. Food and Drug Administration approval based on Immunomedics’ confirmatory data for Trodelvy and Immunomedics’ development of Trodelvy for additional indications; clinical trials (including the anticipated timing of clinical data; the funding therefor, anticipated patient enrollment, trial outcomes, timing or associated costs); the possibility of unfavorable results from clinical trials; regulatory applications and related timelines, including the filing and approval timelines for Biologics License Applications and supplements; filings and approvals relating to the transaction; the expected timing of the completion of the transaction; the ability to complete the transaction considering the various closing conditions; difficulties or unanticipated expenses in connection with integrating the companies; and any assumptions underlying any of the foregoing. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties. Risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include: uncertainties as to the timing of the tender offer and merger; uncertainties as to how many of Immunomedics’ stockholders will tender their stock in the offer; the possibility that competing offers will be made; the possibility that various closing conditions for the transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the effects of the transaction on relationships with employees, other business partners or governmental entities; the difficulty of predicting the timing or outcome of regulatory approvals or actions, if any; Immunomedics’ ability to meet post-approval compliance obligations (on topics including but not limited to product quality, product distribution and supply chain requirements, and promotional and marketing compliance); imposition of significant post-approval regulatory requirements on Immunomedics’ products, including a requirement for a post-approval confirmatory clinical study, or failure to maintain (if received) or obtain full regulatory approval for Immunomedics’ products due to a failure to satisfy post-approval regulatory requirements, such as the submission of sufficient data from a confirmatory clinical study; the impact of competitive products and pricing; other business effects, including the effects of industry, economic or political conditions outside of the companies’ control; transaction costs; actual or contingent liabilities; adverse impacts on business, operating results or financial condition in the future due to pandemics, epidemics or outbreaks, such as COVID-19; and other risks and uncertainties detailed from time to time in the companies’ periodic reports filed with the U.S. Securities and Exchange Commission (the “SEC”), including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K, as well as the Schedule 14D-9 to be filed by Immunomedics and the Schedule TO and related tender offer documents to be filed by Gilead and [Merger Sub], a wholly owned subsidiary of Gilead. All forward-looking statements are based on information currently available to Gilead and Immunomedics, and Gilead and Immunomedics assume no obligation and disclaim any intent to update any such forward-looking statements.
ADDITIONAL INFORMATION AND WHERE TO FIND IT
The tender offer described in this document has not yet commenced. This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares of Immunomedics, nor is it a substitute for any tender offer materials that Gilead, Maui Merger Sub, Inc. or Immunomedics will file with the SEC. A solicitation and an offer to buy shares of Immunomedics will be made only pursuant to an offer to purchase and related materials that Gilead intends to file with the SEC. At the time the tender offer is commenced, Gilead will file a Tender Offer Statement on Schedule TO with the SEC, and Immunomedics will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. IMMUNOMEDICS’ STOCKHOLDERS AND OTHER INVESTORS ARE URGED TO READ THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION WHICH SHOULD BE READ CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. The Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, will be sent to all stockholders of Immunomedics at no expense to them. The Tender Offer Statement and the Solicitation/Recommendation Statement will be made available for free at the SEC’s web site at www.sec.gov. Additional copies may be obtained for free by contacting Gilead or Immunomedics. Free copies of these materials and certain other offering documents will be made available by Gilead by mail to Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404, attention: Investor Relations, by phone at 1-800-GILEAD-5 or 1-650-574-3000, or by directing requests for such materials to the information agent for the offer, which will be named in the Tender Offer Statement. Copies of the documents filed with the SEC by Immunomedics will be available free of charge under the “Investors” section of Immunomedics’ internet website at Immunomedics.com.
In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Gilead and Immunomedics file annual, quarterly and current reports, proxy statements and other information with the SEC. Gilead’s and Immunomedics’ filings with the SEC are also available for free to the public from commercial document-retrieval services and at the website maintained by the SEC at www.sec.gov.
Immunomedics Operating Group Toolkit
Strategic Rationale
How does this acquisition fit into the company’s corporate strategy?
• | This acquisition is transformative to Gilead by providing us with a foundational, first-in-class commercial oncology medicine with potential to generate significant revenue and be best in class. |
• | This is an excellent strategic fit and Trodelvy aligns with all of the principles we’ve laid out as we seek to bring 10 transformative medicines to patients by 2030. Trodelvy is already approved for patients who have received at least two prior therapies for metastatic triple-negative breast cancer, a disease with high unmet need, and has shown promise in other solid tumor types. |
• | With the acquisition of Immunomedics and Trodelvy, Gilead gains an immediate presence in solid tumors with a commercialized product that has significant potential for use in combination with other medicines, including immuno-oncology treatments. |
• | This agreement builds on the series of smaller oncology deals executed this year by giving us a marketed product from which to accelerate our efforts in oncology globally. |
• | The acquisition enhances Gilead’s short-term and long-term growth prospects and is expected to create significant value for our shareholders. |
We said we would go for bolt-ons rather than large scale acquisitions – is this a change in direction?
• | This is in no way a change in direction, and in fact, clearly aligns with our corporate strategy. We have always noted that we would be opportunistic for transformative deals, and the acquisition of Immunomedics is an excellent example of such a deal. |
• | It gives us an immediate presence in solid tumors and brings to Gilead a first-in-class medicine that addresses one of the most difficult to treat forms of cancer, triple-negative breast cancer. |
• | Trodelvy has also shown promise in other difficult-to-treat solid tumor types, where there is also great unmet need. |
Will Immunomedics be folded into Gilead, like Forty Seven, or operate as a stand-alone company, such as Kite?
• | We have tremendous respect for the talented team at Immunomedics, which successfully brought Trodelvy to market. The company has strong clinical and commercial teams and we look forward to working together in the future. |
• | While we are still assessing plans for integration, the intent is to make Immunomedics part of Gilead, as it fits well with the other work we are doing in oncology. The stand-alone Kite structure was driven by the fundamentally unique nature of cell therapy. |
Will Gilead keep the New Jersey site?
• | Between now and the close of the agreement, we will work closely with the Immunomedics team to evaluate the best operating model moving forward, including the role that the New Jersey site will play in our future operations. |
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• | We look forward to welcoming the talented team at Immunomedics and working together to continue to advance this important new medicine for people with cancer. |
How does this deal impact Gilead’s oncology strategy going forward?
• | This acquisition is transformative to Gilead – and our oncology strategy, specifically – because it provides us with a foundational, first-in-class medicine with potential to generate significant revenue and be best in class. |
• | This is an excellent strategic fit and Trodelvy aligns with all of the principles we’ve laid out as we seek to bring 10 transformative medicines to patients by 2030. Trodelvy is already approved for metastatic triple-negative breast cancer, a disease with high unmet need, and has shown promise in other solid tumor types. |
• | With the acquisition of Immunomedics and Trodelvy, Gilead gains an immediate presence in solid tumors with a commercialized product that has significant potential for use in combination with other medicines, including our emerging immuno-oncology pipeline. |
• | This agreement builds on the series of smaller oncology deals executed this year by giving us a marketed product from which to accelerate our efforts in oncology globally. |
How does this deal impact Gilead’s corporate development strategy going forward?
• | Gilead has been extremely active through the first nine months of 2020. We have executed a range of deals, including acquisitions, licensing agreements and several types of innovative collaborations. |
• | These transactions have been largely in oncology, and we are proud of the portfolio we’ve built in a relatively short period of time. Following the close of this transaction, we’ll have a first-in-class and commercial product as well as a portfolio of differentiated early to late-stage clinical programs and innovative research collaborations. |
• | We will continue to look at opportunities to bring the best scientific innovation to Gilead in our core areas, though we expect deals that are bolt-ons or smaller in size in the immediate future as we complete and integrate this transaction. |
How does this impact Gilead’s continued investment in Kite/cell therapy?
• | Gilead remains deeply committed to Kite and to the potential of cell therapy to transform the lives of patients with cancer. |
• | With the approval of Tecartus, Kite has established a franchise and is now the only company with two approved chimeric antigen receptor (CAR) T cell therapies. |
• | This deal gives us an immediate presence in solid tumors, helping to grow Gilead’s leadership position in the field of oncology, which is beneficial and complementary to Kite. |
Will this impact future investment in other therapeutic areas if we are so focused on oncology going forward?
• | Gilead remains committed to immunology and virology as central pieces of our strategy. The acquisition of Trodelvy does not decrease that commitment. |
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What presence does Immunomedics have in Europe and what is the timing for European regulatory approval?
• | Regulatory filing for Trodelvy in Europe is anticipated in the first half of 2021. Immunomedics has a minimal presence in Europe, with just one employee. |
Can you provide further color regarding the geographies where will have rights to Trodelvy?
• | Immunomedics has full rights to Trodelvy except in China, Korea and certain Southeast Asian countries, where it has been partnered with Everest Medicines. |
Terms of the deal and financial impact
The is the largest deal in Gilead’s history. How did you get to this valuation?
• | We’re a disciplined acquirer and believe that the price reflects the value of Trodelvy and the significant and broad potential that this medicine has across a range of tumor types. |
• | Trodelvy is already a commercialized product and the data we have seen in patients with metastatic triple-negative breast cancer are impressive. |
How does this deal impact Gilead’s capital allocation strategy going forward?
• | Gilead will fund this transaction through cash and newly issued debt. |
• | Gilead expects to retain an investment grade credit rating following this transaction and this transaction does not alter Gilead’s stated capital allocation strategy or commitments. |
Trodelvy
What is the mechanism of action?
• | Trodelvy targets Trop-2, an epithelial antigen overexpressed on many solid cancers, including cancers with high unmet need such as metastatic breast cancer, including triple-negative and hormone receptor positive/HER2- breast cancer, metastatic bladder cancer and non-small cell lung cancer (NSCLC). |
• | It is an antibody-drug conjugate (ADC) comprised of three parts: the anti-Trop-2 antibody, the SN-38 payload (metabolite of irinotecan) and a linker. |
• | The potential to combine Trodelvy with checkpoint inhibitors in the frontline setting in the future could provide patients with an alternative to chemotherapy. |
How does Trodelvy differ from other antibody-drug conjugates, such as the ones being developed by Daiichi and Seattle Genetics?
• | Trodelvy is designed to be different than other competitive molecules and we believe that this potentially offers certain advantages. The design of Trodelvy was purposeful and uses a moderately toxic payload, conjugated to a cancer-targeting antibody in a manner that is designed to improve efficacy and therapeutic index. |
• | The relative instability of the linker that connects the antibody enables release at the surface of the cancer cell before internalization, potentially improving cell killing and enabling a so-called “bystander” effect, resulting in killing of adjacent tumor cells, which may express less Trop-2. |
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Beyond mTNBC, which solid tumors are the highest priority?
• | Trodelvy has shown promise as a treatment for earlier forms of triple-negative breast cancer, as well as hormone receptor positive/HER2-negative breast cancer. |
• | Beyond breast cancer, non-small cell lung cancer and bladder cancer are the other core tumor types where we have seen clinical activity. |
• | Outside these core tumor types, we believe there are a number of other areas, where the data are still early, that offer the potential for expansion. |
Trodelvy was approved in the United States under an accelerated or conditional approval. What are the plans for confirmatory studies and subsequent FDA submission?
• | Immunomedics announced in July that its confirmatory study, the Phase 3 ASECNT trial, met its primary endpoint of progression-free survival, as well as key secondary endpoints. The data will be used to support full FDA approval, with regulatory filing anticipated in the fourth quarter of 2020. |
• | In the ASCENT study, Trodelvy demonstrated a statistically significant improvement in the primary endpoint of PFS compared to chemotherapy, with a hazard ratio of 0.41 (95% confidence interval (CI), 0.32-0.52). The median PFS for patients treated with Trodelvy was 5.6 months (95% CI, 4.3-6.3), compared to 1.7 months (95% CI, 1.5-2.6) for chemotherapy (p<0.0001). |
• | Trodelvy also met key secondary endpoints of the study, including overall survival and objective response rate. |
• | The safety profile of Trodelvy observed in the ASCENT study remained consistent with the FDA-approved label, with neutropenia and diarrhea as the most common Grade 3 or 4 adverse events. No new safety signals were observed. |
• | Full results of ASCENT will be presented at the upcoming ESMO conference. |
Will Gilead continue investing in ADCs or is this a one-off?
• | This is not an investment in a technology platform, but rather an opportunity for Gilead to build an immediate presence in solid tumors and gain access to a medicine that treats a very difficult form of cancer with high unmet medical need. |
• | With Trodelvy, we gain a product with significant potential for combination with immuno-oncology candidates and other medicines. |
• | This is an excellent strategic fit. The acquisition of Trodelvy aligns with all of the principles we’ve laid out as we seek to bring 10 transformative medicines to patients by 2030. Trodelvy is already approved to treat patients who have received at least two prior therapies for metastatic triple-negative breast cancer, a disease with high unmet need, and has shown promise in other cancers. |
Commercial
What is the commercial opportunity for Trodelvy?
• | We see tremendous current opportunity for Trodelvy in TNBC and, potential opportunity in other forms of breast cancer and other cancers, including bladder cancer and non-small cell lung. |
• | This deal will enable Gilead to establish an immediate presence in solid tumors. |
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• | Immunomedics has built a talented commercial organization and we look forward to integrating this group into our organization, as we expand our presence in oncology over the next several years. |
• | This agreement accelerates our expansion in oncology and allow us to build on the relationships that the Immunomedics team has developed with key opinion leaders and healthcare professionals. |
Will we incorporate the Immunomedics commercial field teams into Gilead’s Commercial organization?
• | Yes. One of the driving factors in this deal is enabling Gilead to establish an immediate presence in solid tumors. |
• | Immunomedics has built a talented commercial organization and we look forward to integrating this group into our organization, as we expand our presence in oncology over the next several years. |
• | This agreement accelerates that expansion and will allow us to build on the relationships that the Immunomedics team has developed with key opinion leaders and healthcare professionals. |
Forward-looking statements
This communication contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, related to Gilead, Immunomedics and the acquisition of Immunomedics by Gilead that are subject to risks, uncertainties and other factors. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including all statements regarding the intent, belief or current expectation of the companies’ and members of their senior management team. Forward-looking statements include, without limitation, statements regarding the business combination and related matters, prospective performance and opportunities, post-closing operations and the outlook for the companies’ businesses, including, without limitation, the ability of Gilead to advance Immunomedics’ product pipeline and successfully commercialize Trodelvy; expectations for achieving full U.S. Food and Drug Administration approval based on Immunomedics’ confirmatory data for Trodelvy and Immunomedics’ development of Trodelvy for additional indications; clinical trials (including the anticipated timing of clinical data; the funding therefor, anticipated patient enrollment, trial outcomes, timing or associated costs); the possibility of unfavorable results from clinical trials; regulatory applications and related timelines, including the filing and approval timelines for Biologics License Applications and supplements; filings and approvals relating to the transaction; the expected timing of the completion of the transaction; the ability to complete the transaction considering the various closing conditions; difficulties or unanticipated expenses in connection with integrating the companies; and any assumptions underlying any of the foregoing. Investors are cautioned that any such forward -looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties. Risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include: uncertainties as to the timing of the tender offer and merger; uncertainties as to how many of Immunomedics’ stockholders will tender their stock in the offer; the possibility that competing offers will be made; the possibility that various closing conditions for the transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the effects of the transaction on relationships with employees, other business partners or governmental entities; the difficulty of predicting the timing or outcome of regulatory approvals or actions, if any; Immunomedics’ ability to meet post-approval compliance obligations (on topics including but not limited to product quality, product distribution and supply chain requirements, and promotional and marketing compliance); imposition of significant post-approval regulatory requirements on Immunomedics’ products, including a requirement for a post-approval confirmatory clinical study, or failure to maintain (if received) or obtain full regulatory
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approval for Immunomedics’ products due to a failure to satisfy post-approval regulatory requirements, such as the submission of sufficient data from a confirmatory clinical study; the impact of competitive products and pricing; other business effects, including the effects of industry, economic or political conditions outside of the companies’ control; transaction costs; actual or contingent liabilities; adverse impacts on business, operating results or financial condition in the future due to pandemics, epidemics or outbreaks, such as COVID-19; and other risks and uncertainties detailed from time to time in the companies’ periodic reports filed with the U.S. Securities and Exchange Commission (the “SEC”), including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K, as well as the Schedule 14D-9 to be filed by Immunomedics and the Schedule TO and related tender offer documents to be filed by Gilead and Maui Merger Sub, Inc., a wholly owned subsidiary of Gilead. All forward-looking statements are based on information currently available to Gilead and Immunomedics, and Gilead and Immunomedics assume no obligation and disclaim any intent to update any such forward-looking statements.
Additional information and where to find it
The tender offer described in this communication has not yet commenced. This document is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares of Immunomedics, nor is it a substitute for any tender offer materials that Gilead, Purchaser or Immunomedics will file with the SEC. A solicitation and an offer to buy shares of Immunomedics will be made only pursuant to an offer to purchase and related materials that Gilead intends to file with the SEC. At the time the tender offer is commenced, Gilead will file a Tender Offer Statement on Schedule TO with the SEC, and Immunomedics will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. IMMUNOMEDICS’ STOCKHOLDERS AND OTHER INVESTORS ARE URGED TO READ THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION WHICH SHOULD BE READ CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. The Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, will be sent to all stockholders of Immunomedics at no expense to them. The Tender Offer Statement and the Solicitation/Recommendation Statement will be made available for free at the SEC’s web site at www.sec.gov. Additional copies may be obtained for free by contacting Gilead or Immunomedics. Free copies of these materials and certain other offering documents.
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Immunomedics Employee Q&A
What’s Next
When will the acquisition be complete?
• | The transaction is expected to close in the fourth quarter of this year. |
What happens between now and the close of the agreement?
• | Nothing will change between the signing and closing, as Gilead and Immunomedics remain separate independent companies. Antitrust laws require the companies to remain separate, and to wait until the transaction has received the requisite regulatory approvals before we begin working closely together. |
Will I still have a role and when will I find out?
• | Gilead is impressed by the talent of the Immunomedics employees and we look forward to welcoming the experienced team. |
• | We value the innovative work you have done to advance Trodelvy and look forward to working together to continue to advance this important new medicine for patients with cancer. |
• | We are excited to welcome Immunomedics’ employees in the near future. |
Are you keeping the New Jersey site?
• | We look forward to welcoming the talented team at Immunomedics and working together to continue to advance this important new medicine for people with cancer. |
• | Between now and the close of the agreement, we will work closely with the Immunomedics team to evaluate the best operating model moving forward, including the role that the New Jersey site will play in our future operations. |
• | We understand that the New Jersey site is key for the current supply of Trodelvy. We deeply value the site team and the expertise and history with the mAB process. |
Will Immunomedics continue to operate under the Immunomedics name?
• | No. Once the deal closes, Immunomedics will become a subsidiary of Gilead and operate under the Gilead name. |
How is Gilead approaching the COVID-19 pandemic?
• | Since January of this year, when the pandemic first began to emerge and impact our colleagues in Asia, Gilead has prioritized the health and safety of our employees to guide our response. While we do have a number of employees who are working on site daily – those with physical location-dependent roles – the majority of our workforce is working remotely and will continue to do so through the remainder of 2020. |
• | As we work through the transition period, we will provide more information about remote work, our plans for gradual return to site and other benefits offered to our employees to help navigate professional and personal challenges associated with the pandemic. |
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Compensation and benefits
Will my compensation be impacted?
• | Base and bonus will remain the same. After the transaction is complete, you will receive more information about your compensation. |
Will I receive my paycheck on the same schedule?
• | Yes. At this time, paychecks will continue to be issued according to the same schedule and process. If there are future changes in payroll, you will be notified in advance. |
What happens to my 401(k)?
• | Immunomedics’ 401(k) will close at the time of the merger. You will receive information about the opportunity to transfer your account to Fidelity, Gilead’s 401(k) provider. |
What do I need to know about the Gilead 401(k) plan?
• | You will be eligible to enroll in the Gilead Sciences 401(k) plan, which provides a company-matching contribution of 100%, up to $15,000 per year. Gilead's matching contributions vest immediately. You may contribute from 1% to 50% of your salary. |
Please note: If you have already contributed the IRS maximum of $19,500 (or $26,000 if age 50 or over) during 2020 with the Immunomedics 401(k) plan or another employer, you may not contribute to the Gilead plan in 2020.
I have vested and unvested stock options. What happens to stock options now?
• | At the closing of the transaction, each of your stock options that is outstanding, whether vested or unvested, will by virtue of the transaction and without any action on your part, be accelerated and become fully vested and, if unexercised as of immediately prior to the closing of the transaction, be cancelled and converted into the right to receive a cash payment through the company’s payroll equal to the excess of $88 over the per share exercise price of such option times the number of shares subject to such option, less any applicable taxes or other withholdings required by law. After cancellation, your options will cease to exist. |
How does the Gilead ESPP work?
• | Employees may contribute up to 15% of their salary, subject to IRS limits, on an after-tax basis to purchase Gilead common stock at a discount. The purchase price of ESPP stock will be equal to 85% of the lower of the offering price or the fair market value of Gilead stock on the purchase date (e.g., a six month “look-back” period). |
How will the transition to Gilead’s benefits plans work?
• | Gilead employees will be transitioned to Gilead’s benefits programs after the acquisition closes. Please look for more information about that process, as well as information on how to enroll in Gilead’s Employee Stock Purchase Plan, in the coming weeks. |
What U.S. health and wellness benefits does Gilead offer?
• | Gilead offers a comprehensive health and wellness program. We offer the following medical plans: |
Anthem Blue Cross PPO Saver
Anthem Blue Cross EPO
Anthem Blue Cross PPO
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• | Other offerings include Delta Dental, VSP Vision Care, life insurance, accidental death and dismemberment (AD&D), family planning benefits, as well as 12 weeks of parental and family time off. |
• | We also have a $500 wellbeing reimbursement provides help to cover the costs of a variety of personal wellbeing choices, such as gym memberships, athletic equipment, weight loss programs, life coaching, massages, financial advising and planning services. |
• | Additionally, Gilead has introduced a number of benefits this year to help employees manage the personal and professional challenges of the COVID-19 pandemic. |
Will we move to Gilead’s holiday calendar? What time-off benefits and holidays does Gilead offer and will we move to Gilead’s or maintain our own?
• | Yes, Immunomedics employees will move to Gilead’s holiday and time-off benefits when Immunomedics employees are transitioned to Gilead’s benefits and systems. |
• | In the U.S., Gilead offers 15 days of vacation for new hires, which increases to 20 days after five years of service. Gilead also provides 10 sick days that employees can use for their own illness or to care for an ill dependent. |
• | Additionally, Gilead offers 14 paid holidays, including a July 4th holiday week and one floating holiday. Gilead also offers a winter shutdown (we will be closed December 25, 2020 – January 4, 2021). |
• | The company also offers a paid day for employees to use to volunteer at an organization of their choosing. |
• | Gilead offers 12 weeks of paid family or parental time off to help employees care for an ill family member or to bond with a new child when taking a leave of absence. |
• | Immunomedics employees’ years of service will transfer and be counted toward the number of years of employment at Gilead at the time the acquisition closes. This will apply to vacation accrual. |
When will my 2020 bonus be paid?
• | Immunomedics employees will receive their 2020 bonuses in February/March 2021. The corporate achievement will be 150%, based on the outstanding achievements this year. Individual achievement will be evaluated by employees’ manager. |
Will the corporate part of my 2020 bonus be based on Gilead results or Immunomedics results?
• | Employee bonuses for 2020 will be evaluated based on Immunomedics’ results. |
Will my performance review process stay the same?
• | We anticipate it will be the same in 2020 and will work through the details during the transition period. |
3
CONFIDENTIAL - FOR INTERNAL USE ONLY
Information Technology
• | When will I have a Gilead email address? |
You will keep your current email address while we continue to evaluate the best way to integrate the two companies.
• | Will I receive a Gilead computer? |
You will keep your current computer while we continue to evaluate the best way to integrate the two companies.
• | Will I keep my phone numbers (office & mobile)? |
Yes.
Forward-looking statements
This communication contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, related to Gilead, Immunomedics and the acquisition of Immunomedics by Gilead that are subject to risks, uncertainties and other factors. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including all statements regarding the intent, belief or current expectation of the companies’ and members of their senior management team. Forward-looking statements include, without limitation, statements regarding the business combination and related matters, prospective performance and opportunities, post-closing operations and the outlook for the companies’ businesses, including, without limitation, the ability of Gilead to advance Immunomedics’ product pipeline and successfully commercialize Trodelvy; expectations for achieving full U.S. Food and Drug Administration approval based on Immunomedics’ confirmatory data for Trodelvy and Immunomedics’ development of Trodelvy for additional indications; clinical trials (including the anticipated timing of clinical data; the funding therefor, anticipated patient enrollment, trial outcomes, timing or associated costs); the possibility of unfavorable results from clinical trials; regulatory applications and related timelines, including the filing and approval timelines for Biologics License Applications and supplements; filings and approvals relating to the transaction; the expected timing of the completion of the transaction; the ability to complete the transaction considering the various closing conditions; difficulties or unanticipated expenses in connection with integrating the companies; and any assumptions underlying any of the foregoing. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements.
Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties. Risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include: uncertainties as to the timing of the tender offer and merger; uncertainties as to how many of Immunomedics’ stockholders will tender their stock in the offer; the possibility that competing offers will be made; the possibility that various closing conditions for the transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the effects of the transaction on relationships with employees, other business partners or governmental entities; the difficulty of predicting the timing or outcome of regulatory approvals or actions, if any; Immunomedics’ ability to meet post-approval compliance obligations (on topics including but not limited to product quality, product distribution and supply chain requirements, and promotional and marketing compliance); imposition of significant post-approval regulatory requirements on Immunomedics’ products, including a requirement for a post-approval confirmatory clinical study, or failure to maintain (if received) or obtain full regulatory approval for Immunomedics’ products due to a
4
CONFIDENTIAL - FOR INTERNAL USE ONLY
failure to satisfy post-approval regulatory requirements, such as the submission of sufficient data from a confirmatory clinical study; the impact of competitive products and pricing; other business effects, including the effects of industry, economic or political conditions outside of the companies’ control; transaction costs; actual or contingent liabilities; adverse impacts on business, operating results or financial condition in the future due to pandemics, epidemics or outbreaks, such as COVID-19; and other risks and uncertainties detailed from time to time in the companies’ periodic reports filed with the U.S. Securities and Exchange Commission (the “SEC”), including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K, as well as the Schedule 14D-9 to be filed by Immunomedics and the Schedule TO and related tender offer documents to be filed by Gilead and Maui Merger Sub, Inc., a wholly owned subsidiary of Gilead. All forward-looking statements are based on information currently available to Gilead and Immunomedics, and Gilead and Immunomedics assume no obligation and disclaim any intent to update any such forward-looking statements.
Additional information and where to find it
The tender offer described in this communication has not yet commenced. This document is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares of Immunomedics, nor is it a substitute for any tender offer materials that Gilead, Purchaser or Immunomedics will file with the SEC. A solicitation and an offer to buy shares of Immunomedics will be made only pursuant to an offer to purchase and related materials that Gilead intends to file with the SEC. At the time the tender offer is commenced, Gilead will file a Tender Offer Statement on Schedule TO with the SEC, and Immunomedics will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. IMMUNOMEDICS’ STOCKHOLDERS AND OTHER INVESTORS ARE URGED TO READ THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION WHICH SHOULD BE READ CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. The Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, will be sent to all stockholders of Immunomedics at no expense to them. The Tender Offer Statement and the Solicitation/Recommendation Statement will be made available for free at the SEC’s web site at www.sec.gov. Additional copies may be obtained for free by contacting Gilead or Immunomedics. Free copies of these materials and certain other offering documents.
5
Exhibit 99.5
Gilead Tweet (@GileadSciences), September 13, 2020
Today we announced we will acquire @ImmunomedicsInc, providing Gilead with a foundational, first-in-class commerical oncology product.
bit.ly/2FiALrD.
Forward-Looking Statements
This document contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, related to Gilead, Immunomedics and the acquisition of Immunomedics by Gilead that are subject to risks, uncertainties and other factors. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including all statements regarding: the intent, belief or current expectation of the companies’ and members of their senior management team. Forward-looking statements include, without limitation, statements regarding the business combination and related matters, prospective performance and opportunities, post-closing operations and the outlook for the companies’ businesses, including, without limitation, the ability of Gilead to advance Immunomedics’ product pipeline and successfully commercialize Trodelvy; expectations for achieving full U.S. Food and Drug Administration approval based on Immunomedics’ confirmatory data for Trodelvy and Immunomedics’ development of Trodelvy for additional indications; clinical trials (including the anticipated timing of clinical data, the funding therefor, anticipated patient enrollment, trial outcomes, timing or associated costs); the possibility of unfavorable results from clinical trials; regulatory applications and related timelines, including the filing and approval timelines for Biologics License Applications and supplements; filings and approvals relating to the transaction; the expected timing of the completion of the transaction; the ability to complete the transaction considering the various closing conditions; difficulties or unanticipated expenses in connection with integrating the companies; and any assumptions underlying any of the foregoing. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties. Risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include: uncertainties as to the timing of the tender offer and merger; uncertainties as to how many of Immunomedics’ stockholders will tender their stock in the offer; the possibility that competing offers will be made; the possibility that various closing conditions for the transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the effects of the transaction on relationships with employees, other business partners or governmental entities; the difficulty of predicting the timing or outcome of regulatory approvals or actions, if any; Immunomedics’ ability to meet post-approval compliance obligations (on topics including but not limited to product quality, product
distribution and supply chain requirements, and promotional and marketing compliance); imposition of significant post-approval regulatory requirements on Immunomedics’ products, including a requirement for a post-approval confirmatory clinical study, or failure to maintain (if received) or obtain full regulatory approval for Immunomedics’ products due to a failure to satisfy post-approval regulatory requirements, such as the submission of sufficient data from a confirmatory clinical study; the impact of competitive products and pricing; other business effects, including the effects of industry, economic or political conditions outside of the companies’ control; transaction costs; actual or contingent liabilities; adverse impacts on business, operating results or financial condition in the future due to pandemics, epidemics or outbreaks, such as COVID-19; and other risks and uncertainties detailed from time to time in the companies’ periodic reports filed with the U.S. Securities and Exchange Commission (the “SEC”), including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K, as well as the Schedule 14D-9 to be filed by Immunomedics and the Schedule TO and related tender offer documents to be filed by Gilead and Purchaser. All forward-looking statements are based on information currently available to Gilead and Immunomedics, and Gilead and Immunomedics assume no obligation and disclaim any intent to update any such forward-looking statements.
Additional Information and Where to Find It
The tender offer described in this document has not yet commenced. This document is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares of Immunomedics, nor is it a substitute for any tender offer materials that Gilead, Purchaser or Immunomedics will file with the SEC. A solicitation and an offer to buy shares of Immunomedics will be made only pursuant to an offer to purchase and related materials that Gilead intends to file with the SEC. At the time the tender offer is commenced, Gilead will file a Tender Offer Statement on Schedule TO with the SEC, and Immunomedics will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. IMMUNOMEDICS’ STOCKHOLDERS AND OTHER INVESTORS ARE URGED TO READ THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION WHICH SHOULD BE READ CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. The Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, will be sent to all stockholders of Immunomedics at no expense to them. The Tender Offer Statement and the Solicitation/Recommendation Statement will be made available for free at the SEC’s web site at www.sec.gov. Additional copies may be obtained for free by contacting Gilead or Immunomedics. Free copies of these materials and certain other offering documents will be made available by Gilead by mail to Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404, attention: Investor Relations, by phone at 1-800-GILEAD-5 or 1-650-574-3000, or by directing requests for such materials to the information agent for the offer, which will be named in the Tender Offer Statement. Copies of the documents filed with the SEC by Immunomedics will be available free of charge under the “Investors” section of Immunomedics’ internet website at Immunomedics.com.
In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Gilead and Immunomedics file annual, quarterly and current reports, proxy statements and other information with the SEC. Gilead’s and Immunomedics’ filings with the SEC are also available for free to the public from commercial document-retrieval services and at the website maintained by the SEC at www.sec.gov.
2
Exhibit 99.6
Email to Immunomedics Employees
Hello Everyone,
I’m very much looking forward to joining you virtually tomorrow for the townhall and wanted to share a few brief words in the meantime.
Let me start by saying how much respect I have for the incredible work you are doing at Immunomedics, and everything you have achieved to date. That respect is very much shared by the team at Gilead. We are delighted to have this opportunity to work with you in helping to bring the benefits of Trodelvy to patients around the world.
I know that the success you have achieved at Immunomedics is only possible when you have highly talented and committed individuals across the organization. We feel fortunate that we will now benefit from your talent and expertise, as we continue to build Gilead’s growing presence in oncology. I imagine you will have many questions about the future as you digest today’s news, and I want to assure you that we will do our best to provide answers as quickly as possible.
I have enjoyed getting to know Behzad in the lead up to today and I’m looking forward to learning more about the team and the work that you do. It is already clear to me that our two companies share common values and principles and a mission of helping patients to defeat their cancer. This mission has been a constant for me throughout my career and is important to all of us at Gilead.
I look forward to connecting tomorrow and to starting the conversation about what I believe will be an exciting future ahead.
Dan
Forward-Looking Statements
This document contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, related to Gilead, Immunomedics and the acquisition of Immunomedics by Gilead that are subject to risks, uncertainties and other factors. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including all statements regarding: the intent, belief or current expectation of the companies’ and members of their senior management team. Forward-looking statements include, without limitation, statements regarding the business combination and related matters, prospective performance and opportunities, post-closing operations and the outlook for the companies’ businesses, including, without limitation, the ability of Gilead to advance Immunomedics’ product pipeline and successfully commercialize Trodelvy; expectations for achieving full U.S. Food and Drug Administration approval based on Immunomedics’ confirmatory data for Trodelvy and Immunomedics’ development of Trodelvy for additional indications; clinical trials (including the anticipated timing of clinical data, the funding therefor, anticipated patient enrollment, trial outcomes, timing or associated costs); the possibility of unfavorable results from clinical trials; regulatory applications and related timelines, including the filing and approval timelines for Biologics License Applications and supplements; filings and approvals relating to the transaction; the expected timing of the completion of the transaction; the ability to complete the transaction considering the various closing conditions; difficulties or unanticipated expenses in connection with integrating the companies; and any assumptions underlying any of the foregoing. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties. Risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include: uncertainties as to the timing of the tender offer and merger; uncertainties as to how many of Immunomedics’ stockholders will tender their stock in the offer; the possibility that competing offers will be made; the possibility that various closing conditions for the transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or
refuse to grant approval for the consummation of the transaction; the effects of the transaction on relationships with employees, other business partners or governmental entities; the difficulty of predicting the timing or outcome of regulatory approvals or actions, if any; Immunomedics’ ability to meet post-approval compliance obligations (on topics including but not limited to product quality, product distribution and supply chain requirements, and promotional and marketing compliance); imposition of significant post-approval regulatory requirements on Immunomedics’ products, including a requirement for a post-approval confirmatory clinical study, or failure to maintain (if received) or obtain full regulatory approval for Immunomedics’ products due to a failure to satisfy post-approval regulatory requirements, such as the submission of sufficient data from a confirmatory clinical study; the impact of competitive products and pricing; other business effects, including the effects of industry, economic or political conditions outside of the companies’ control; transaction costs; actual or contingent liabilities; adverse impacts on business, operating results or financial condition in the future due to pandemics, epidemics or outbreaks, such as COVID-19; and other risks and uncertainties detailed from time to time in the companies’ periodic reports filed with the U.S. Securities and Exchange Commission (the “SEC”), including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K, as well as the Schedule 14D-9 to be filed by Immunomedics and the Schedule TO and related tender offer documents to be filed by Gilead and Purchaser. All forward-looking statements are based on information currently available to Gilead and Immunomedics, and Gilead and Immunomedics assume no obligation and disclaim any intent to update any such forward-looking statements.
Additional Information and Where to Find It
The tender offer described in this document has not yet commenced. This document is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares of Immunomedics, nor is it a substitute for any tender offer materials that Gilead, Purchaser or Immunomedics will file with the SEC. A solicitation and an offer to buy shares of Immunomedics will be made only pursuant to an offer to purchase and related materials that Gilead intends to file with the SEC. At the time the tender offer is commenced, Gilead will file a Tender Offer Statement on Schedule TO with the SEC, and Immunomedics will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. IMMUNOMEDICS’ STOCKHOLDERS AND OTHER INVESTORS ARE URGED TO READ THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION WHICH SHOULD BE READ CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. The Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, will be sent to all stockholders of Immunomedics at no expense to them. The Tender Offer Statement and the Solicitation/Recommendation Statement will be made available for free at the SEC’s web site at www.sec.gov. Additional copies may be obtained for free by contacting Gilead or Immunomedics. Free copies of these materials and certain other offering documents will be made available by Gilead by mail to Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404, attention: Investor Relations, by phone at 1-800-GILEAD-5 or 1-650-574-3000, or by directing requests for such materials to the information agent for the offer, which will be named in the Tender Offer Statement. Copies of the documents filed with the SEC by Immunomedics will be available free of charge under the “Investors” section of Immunomedics’ internet website at Immunomedics.com.
In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Gilead and Immunomedics file annual, quarterly and current reports, proxy statements and other information with the SEC. Gilead’s and Immunomedics’ filings with the SEC are also available for free to the public from commercial document-retrieval services and at the website maintained by the SEC at www.sec.gov.
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