At the beginning of this month I posted about the
acquisition of Regulus Therapeutics by Novartis, just three months after Regulus announced Phase 1b MAD trial results for its farabursen in ADPKD asset.
Novartis agreed to pay US$800m (US$7 per share) upfront for Regulus, with another US$7 per share payable if farabursen received marketing approval from the FDA. In total, if the drug is approved, Novartis will pay ~US$1.7bn (A$2.65bn).
As discussed in my post, the market cap of Regulus (RGLS) was just US$110m at the beginning of February this year following announcement of positive efficacy and safety results from the Phase 1b trial of farabursen in ADPKD, as well as achievement of alignment with the FDA on a pivotal trial design. Two years earlier, in March 2023, when Regulus was still dosing the first cohort in its Phase 1b MAD trial, its market cap was just US$14m.
During that two year period in which Regulus rose from a market cap of US$14m (A$22m) to US$800m (A$1.25bn - with a further A$1.4bn contingent on FDA approval), Regulus completed two private placements totalling US$115m.
As stated in my original post, farabursen in ADPKD was Regulus’ only clinical-stage asset and its other programs were only at lead optimization stage.
I also noted that Novartis was not the only large pharma with an interest in such renal assets; others include Astra Zeneca, GSK, Amgen, AbbVie, Pfizer and Roche.
Regulus this week filed the preliminary proxy statement related to its acquisition by Novartis. Such statements are always of interest because of the detailed background information that is revealed about the deal process.
I have provided a slightly shortened version of the background information to this deal in timeline form below; the original 14D-9 document can be accessed
here.March 2024Regulus releases positive topline data from the second cohort of patients in its Phase 1b multiple-ascending dose (MAD) trial of farabursen in ADPKD.
Private placement equity financing announced for US$100 m.
June 2024Positive topline data from third cohort of patients announced.
Regulus engages Evercore as a financial advisor to assist in evaluating potential strategic alternatives to maximize shareholder value, including partnership and collaboration opportunities.
Seventeen potential counterparties, not including Novartis, hold meetings with management about potential partnership and collaboration opportunities.
Regulus and an affiliate of Novartis already were party to a mutual confidentiality agreement initially entered into in January 2018 and amended in December 2020. This confidentiality agreement did not include a standstill provision.
July 8, 2024One of the counterparties, a global biopharmaceutical company (Party A), submits a written non-binding indication of interest to acquire an exclusive global license to develop and commercialize farabursen.
Board decides that a global licensing structure for the company’s lead asset is not in best interest of the company.
September - October 2024Party A as well as three other global biopharma companies (B, C and D) continued discussions on potential partnership and collaboration opportunities.
October 2, 2024Party A submits a revised written non-binding indication of interest regarding a co-development arrangement with respect to farabursen, which includes an upfront payment, certain contingent amounts tied to achievement of certain development milestones, shared costs related to farabursen, and shared revenue from US sales. Board rejects offer as not sufficiently attractive.
October 10, 2024Party B submits a written non-binding indication of interest regarding a co-development arrangement with respect to farabursen, which includes an upfront payment, certain contingent payments tied to achievement of certain regulatory approvals and certain net sales milestones, with Regulus being responsible for a portion of all costs related to the development of farabursen, and having the right to receive a portion of revenue generated by farabursen. Board decides that the offer is not sufficiently attractive.
November 5, 2024Party C submits a written non-binding indication of interest regarding an exclusive global license to develop and commercialize farabursen. Board again states that a global licensing structure for the Company’s lead asset would not be in the best interest of the Company, and the parties continue to discuss other potential structures.
December 12, 2024Party D submits a written non-binding indication of interest regarding a co-development arrangement with respect to farabursen, which includes an upfront payment, certain contingent payments tied to achievement of certain development milestones and certain net sales milestones, shared development costs related to farabursen in the US, and shared US revenue generated by farabursen. This proposed structure is also rejected by the Board.
January 10, 2025Regulus and an affiliate of Novartis enter into a new confidentiality agreement which does not contain a standstill provision.
January 14 and January 15, 2025Senior members of Regulus management hold meetings with representatives from Parties A, B, C, D, another global biotechnology company (Party E) and Novartis, in connection with the J.P. Morgan Healthcare Conference.
January 29, 2025Regulus announces topline data from an interim analysis of the fourth cohort of its Phase 1b MAD clinical trial, which shows continued mechanistic dose response, and exploratory results of imaging-based biomarkers, which continue to show reduction in height-adjusted total kidney volume (htTKV) growth rate. The Company also announces a successful End-of-Phase 1 meeting with the FDA, with agreement on key components of a Phase 3 single pivotal trial for potential accelerated approval.
February 2025Senior members of Regulus management and Evercore hold additional meetings with representatives of multiple potential counterparties, including Novartis, regarding potential partnership and collaboration opportunities.
February 28, 2025Party B advises that it doesn’t intend to submit further revised proposals.
March 3, 2025Party A communicates that it could be interested in obtaining full control of farabursen via an acquisition of the Company as well as a possible spinout of certain early stage assets of the Company.
March 7, 2025Party D submits a revised non-binding indication of interest regarding a co- development arrangement with respect to farabursen, which includes a higher upfront payment, certain contingent payments tied to achievement of certain development milestones and certain net sales milestones, shared development costs related to farabursen in the US, and shared revenue generated by farabursen in the US. Evercore communicates to Party D that their proposal would be reviewed with Company management and Board.
March 11, 2025Party C submits a revised non-binding indication of interest regarding an exclusive global license arrangement with respect to farabursen, which includes a higher upfront payment than offered before. Evercore communicates to Party C that their proposal would be reviewed with Company management and Board.
March 13, 2025Regulus Board hold a meeting with management and representatives of Evercore to discuss the status of partnering discussions.
March 17, 2025Party A reaches out with a verbal non-binding proposal to acquire the Company for $2.50 per share in cash and a contingent value right (“CVR”
of $0.75 per share, with the exact CVR milestone to be further discussed as well as a possible spinout of certain early stage assets of the Company.
March 19, 2025Company Board discuss the strategic outreach process to date.
March 20, 2025Board rejects Party A’s March 17, 2025 proposal as inadequate from a financial perspective.
March 27, 2025Regulus announces positive topline data from the fourth cohort of its Phase 1b MAD trial. Later the same day, senior members of the Company’s management and Evercore hold calls with representatives of multiple potential counterparties, including Party A, Party D and Novartis, to discuss the Company’s data announcement.
March 28, 2025Party A indicates that in light of the data announced the previous day, it would provide a revised non-binding indication of interest to acquire the Company. Later the same day, Party A submits a written non-binding indication of interest to acquire the Company for $2.50 per share in cash and a CVR of $0.80 per share, with such CVR becoming payable upon the Company receiving FDA approval of farabursen with an indication that farabursen slows the progression of cyst development and kidney function decline in patients with rapidly progressing ADPKD.
Party D advises Evercore that it could be interested in obtaining full control of farabursen via an acquisition of the Company.
March 30, 2025Board advises Party A that its March 28 proposal is inadequate from a financial perspective.
April 4, 2025Novartis submits a written non-binding indication of interest to acquire the Company for $3.00 per share in cash and a CVR of $1.50 per share, with such CVR becoming payable upon the Company receiving FDA approval of farabursen in ADPKD.
April 7, 2025Party C advises that it doesn’t intend to submit further revised proposals.
April 11, 2025Party A submits a revised written non-binding indication of interest to acquire the Company for $4.00 per share in cash and a CVR of $3.50 per share, with such CVR becoming payable upon achievement of certain net sales milestones of farabursen.
April 13 and 14, 2025Board reviews offers of both Party A and Novartis. Board advises Novartis and Party A that the bids insufficiently value the Company and that, given the contingent nature of CVRs, the parties should maximize the amount of the upfront portion of the consideration.
April 15, 2025Party A submits a revised written non-binding indication of interest to acquire the Company for $5.00 per share in cash and CVRs of $5.00 in the aggregate, comprised of (i) a CVR of $2.00 per share, payable upon the Company receiving FDA approval of farabursen with an indication that farabursen slows the progression of cyst development and kidney function decline in patients with rapidly progressing ADPKD and (ii) a CVR of $3.00 per share, payable upon achievement of certain net sales milestones of farabursen.
April 16, 2025Novartis submits a revised written non-binding indication of interest to acquire the Company for $3.50 per share in cash and a CVR of $3.50 per share, with such CVR becoming payable upon the Company receiving FDA approval of farabursen in ADPKD.
Party D advises that it doesn’t intend to submit further revised proposals.
April 17, 2025The Board requests that Evercore seek improved proposals and ask both Party A and Novartis to review and comment on an initial draft merger agreement.
Party E advises that it doesn’t intend to submit an offer to acquire the Company.
April 20, 2025Novartis submits a revised written non-binding indication of interest to acquire the Company for $6.00 per share in cash and a CVR of $6.00 per share, with such CVR becoming payable upon the Company receiving FDA approval of farabursen in ADPKD.
April 23, 2025Novartis submits a revised written non-binding indication of interest to acquire the Company for $6.50 per share in cash and a CVR of $6.50 per share, with such CVR becoming payable upon the Company receiving FDA approval of farabursen in ADPKD. This proposal is conditioned on the Company entering into an exclusivity agreement with Novartis regarding negotiations of a potential transaction.
Party A provides an updated written non-binding indication of interest to acquire the Company for $5.00 per share in cash and a CVR of $5.00 payable in full upon FDA approval of farabursen with no sunset date on the achievement of the CVR.
April 24 and April 25, 2025Senior members of Regulus management hold due diligence calls with representatives of Party A and Novartis.
April 27, 2025Novartis provides a verbal revised non-binding indication of interest to acquire the Company for $6.00 per share in cash and a CVR of $6.00 per share, with such CVR becoming payable upon the Company receiving FDA approval of farabursen in ADPKD. Novartis’s revised indication of interest is not conditioned on the Company entering into an exclusivity agreement with Novartis regarding negotiations of a potential transaction.
Evercore requests of both Novartis and Party A that they submit their “best and final” offers by a specified time the following day.
April 28, 2025Novartis submits a “best and final” revised written non-binding indication of interest to acquire the Company for $7.00 per share in cash and a CVR of $7.00 per share, with such CVR becoming payable upon the Company receiving FDA approval of farabursen in ADPKD on or prior to December 31, 2034.
Party A indicates that its April 23, 2025 proposal should be treated as Party A’s best and final offer.
Evercore holds a call with representatives of Novartis to confirm that Regulus is willing to move forward with Novartis on the basis of Novartis’s April 28 proposal, subject to finalizing remaining open legal issues in the draft Merger Agreement.
April 29, 2025Evercore offers its opinion to the Board that the Novartis offer is fair, from a financial point of view, to shareholders.
Regulus company management recommend in favour of the transaction.
April 30, 2025The Merger Agreement is executed.
(20min delay)