Q3 2024 Results - 1 - Q3 2024 Results November 7, 2024 Legal Disclaimer Important Information This presentation does not constitute an offer or invitation to purchase or subscribe shares, in accordance with the provisions of the Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC, the Spanish Securities Market and Inv ...

Core Viewpoint - Grifols SA has ended discussions with Brookfield Capital Partners regarding a potential acquisition, following a rejected indicative offer of 6.45 billion euros ($6.81 billion) for the company [1][2]. Financial Performance - For the first nine months of 2024, Grifols reported a revenue growth of 9.1% year-over-year at constant currency, with gains across all business units [3]. - The company achieved an adjusted EBITDA of 1.7 billion euros over the past 12 months [3]. - Grifols improved its financial stability by reducing debt after selling a 20% stake in Shanghai RAAS for 1.6 billion euros [3]. Acquisition Discussions - Brookfield Capital's proposal was deemed to undervalue Grifols' growth prospects and long-term potential, leading to the mutual agreement to terminate discussions [2]. - In August, Brookfield Asset Management sought 9.5 billion euros ($10.6 billion) in debt financing for a potential take-private deal for Grifols [4]. - Grifols had previously confirmed that Brookfield engaged in preliminary discussions with key shareholders regarding a potential joint offer to delist the company's shares [4]. Legal Issues - The National Court has accepted a complaint from the Anti-Corruption Prosecutor's Office to investigate Gotham City Research and others for allegedly disseminating misleading information about Grifols to manipulate its stock price [5]. - Gotham City Research released a short report in January alleging that Grifols manipulated its accounts to present a distorted leverage ratio [6]. Stock Performance - Grifols' stock (GRFS) experienced a decline of 12.9%, trading at $7.03 during the premarket session [7].

Core Viewpoint - Grifols' shares fell over 7% after Brookfield Asset Management withdrew its acquisition proposal, which was valued at €6.45 billion (approximately $6.8 billion), due to disagreements on the company's valuation [1][2] Company Performance - Grifols' stock has declined 30.2% year-to-date, significantly underperforming the industry average decline of 4.5% [5] - The company's net financial debt stood at €9.2 billion, with a liquidity position of €704 million, raising concerns about its cash flow generation capabilities [4] Acquisition Attempts - The negotiations between Grifols and Brookfield ended after the Grifols board rejected the acquisition offer, citing that it undervalued the company's long-term potential [1] - Brookfield was also in discussions with banks to raise funds for the acquisition, which would have included refinancing Grifols' existing debt [2] Management Changes - In response to ongoing concerns, Grifols appointed new management and removed family members from executive roles [8]

Core Viewpoint - Grifols' shares fell over 8% after the company's board rejected Brookfield Asset Management's acquisition offer of €6.45 billion (approximately $6.8 billion), citing that the valuation significantly undervalues the company's long-term potential [1] Group 1: Company Performance - Grifols' stock has declined 26.8% year-to-date, compared to a 6.9% decline in the industry [4] - The recent drop in share price was influenced by short-seller Gotham City Research's reports alleging that Grifols overstated earnings and understated debt, alongside negative news regarding cash flows and accounting adjustments related to investments in China [6] - In response to these concerns, Grifols appointed new management and removed family members from executive roles [7] Group 2: Acquisition Attempt - Brookfield is in discussions with banks to raise funds for the acquisition, which will also be used to refinance Grifols' existing debt, including loans and high-yield bonds [2] - A clause in Grifols' existing debt agreements allows bondholders to demand early repayment at a premium if the company is taken private, necessitating this refinancing [2] Group 3: Investor Sentiment - Investors reacted negatively to Brookfield's valuation, leading to concerns that the acquisition deal may not proceed due to the lower-than-expected offer [3]

Group 1 - The article expresses a beneficial long position in the shares of GRFS, indicating a positive outlook on the company's stock performance [1] - The author emphasizes the importance of conducting due diligence and research prior to any investment, highlighting the risks associated with short-term trading and options trading [2] - The article clarifies that past performance is not indicative of future results, and no specific investment recommendations are provided [3] Group 2 - The author owns European/Scandinavian tickers of all European/Scandinavian companies mentioned, as well as Canadian tickers of Canadian stocks discussed [2] - There are specific withholding tax risks associated with investing in European/Non-US stocks, which investors should consider [2]

Core Viewpoint - Grifols' shares increased nearly 7% following reports of Brookfield Asset Management's potential acquisition and plans to raise €9.5 billion ($10.6 billion) in debt for refinancing existing obligations [1][2]. Group 1: Acquisition Details - Brookfield Asset Management is in discussions with banks to secure €9.5 billion ($10.6 billion) in debt for the potential acquisition of Grifols [1][2]. - The funds will primarily be used to refinance Grifols' existing debt, which includes loans and high-yield bonds [2]. - A clause in Grifols' debt agreements allows bondholders to demand early repayment at a premium if the company is taken private, necessitating this refinancing [2]. Group 2: Stakeholder Involvement - The potential takeover discussions come after Brookfield and key shareholders, including the Grifols family, expressed interest in acquiring the company [3]. - The Grifols family holds approximately 30% of the company's shares, indicating significant insider support for the acquisition [3]. Group 3: Financial Context - If the acquisition proceeds, the debt package is expected to consist of €8 billion in drawn debt and a revolving credit facility of up to €1.5 billion [4]. - This acquisition could be the largest takeover of a publicly-traded European company since at least 2022 [4]. - Year-to-date, Grifols' shares have declined by 33.7%, contrasting with a 1.8% decline in the industry [4]. Group 4: Company Challenges - Grifols faced a significant drop in share value due to allegations from short-seller Gotham City Research, which accused the company of overstating earnings and understating debt [4]. - Negative news regarding cash flows and accounting adjustments related to investments in China further exacerbated the company's challenges [4]. - In response to these issues, Grifols appointed new management and removed family members from executive roles [4].

Core Viewpoint - GigaGen Inc. has received FDA clearance for its Investigational New Drug application to initiate a Phase 1 trial for GIGA-2339, a recombinant polyclonal drug aimed at treating hepatitis B virus (HBV) infection, marking a significant advancement in the treatment landscape for HBV [1][5]. Group 1: Company Overview - GigaGen Inc. is a biotechnology company focused on developing transformative antibody drugs for immunodeficiencies, infectious diseases, and checkpoint-resistant cancers [1][16]. - GigaGen's platform utilizes next-generation technology to create recombinant polyclonal antibodies, which are potentially more effective than natural immune responses [11][16]. - GigaGen is a subsidiary of Grifols, a global healthcare company known for its leadership in plasma-derived medicines and transfusion medicine [12][16]. Group 2: Product Development - GIGA-2339 is the first recombinant polyclonal therapeutic in development specifically for chronic HBV infection, with trial initiation expected in Q4 2024 [5]. - The drug contains over 1,000 fully human recombinant anti-HBV antibodies, designed to replicate the natural immune response [1][5]. - GIGA-2339 has demonstrated over 2,000 times the potency of plasma-derived HBV drugs and has shown efficacy in neutralizing and clearing HBV's viral DNA in mouse models [5][11]. Group 3: Market Context - HBV currently affects more than 296 million people globally, leading to over 800,000 deaths annually, with no existing cure available [2][5]. - Existing therapies can only halt viral replication and minimally reduce viral protein levels, highlighting the need for more effective treatments like GIGA-2339 [2][5]. Group 4: Clinical Trial Details - The Phase 1 clinical trial will focus on assessing the safety and tolerability of GIGA-2339 in patients with confirmed HBV infection [3][5]. - The trial is a dose escalation study, which is a common approach in early-phase clinical trials to determine the optimal dosing [3]. Group 5: Strategic Importance - The FDA's clearance of the IND application is seen as a significant milestone in Grifols' commitment to developing innovative antibody drugs for infectious diseases [5]. - GigaGen's approach to creating a diverse range of antibodies positions it uniquely in the market, potentially offering a functional cure for chronic HBV [5][11].

Approval, which also includes biweekly dosing, follows phase 4 study data demonstrating comparable total Ig levels when administering XEMBIFY every two weeks versus weekly Increasing adoption of XEMBIFY is part of Grifols' broader Ig business strategy focused on treating immunodeficiencies, which represent more than half of the total Ig market and whose growth is expected to outpace other indications XEMBIFY becomes the first 20% SCIg with this extended label, allowing patients to begin SCIg therapy without ...

Core Insights - Grifols has received FDA approval for an expanded label for XEMBIFY, the first and only 20% subcutaneous immunoglobulin (SCIg) that allows treatment-naïve patients to start therapy without prior intravenous treatment [1][2][3] - The approval includes biweekly dosing, which has shown comparable total Ig levels to weekly dosing in a phase 4 clinical trial [3][4] - The adoption of XEMBIFY aligns with Grifols' broader strategy in the immunoglobulin market, which is expected to grow significantly due to increasing cases of primary and secondary immunodeficiencies [5][6] Company Strategy - The expanded label for XEMBIFY enhances patient convenience and flexibility, differentiating it from other SCIg therapies [6] - Grifols plans to launch the new label in the U.S. in Q3 2024, reflecting its commitment to adapting to patient needs [6] - The global immunoglobulin market is projected to grow in the high single digits, with immunodeficiencies accounting for up to 55% of the total market [5] Clinical Data - The phase 4 clinical trial (NCT04566692) included 27 subjects across 18 U.S. sites and demonstrated non-inferiority in total Ig levels for biweekly dosing compared to weekly dosing [3][4] - No unique safety issues were identified in the trial, and the tolerability profiles were consistent between dosing schedules [4] Product Information - XEMBIFY is a 20% solution of purified human immunoglobulin, primarily immune globulin G (IgG), made from large pools of human plasma [8][9] - It is indicated for primary humoral immunodeficiency (PI) in patients aged 2 years and older in the U.S., and for both PI and select secondary immunodeficiencies in Europe, Canada, and Australia [7]

Brookfield and family member shareholders of Grifols are in talks to take the Spanish pharmaceutical firm private. The potential buyers asked the board for information so they could do due diligence. Both sides say no agreement has been reached. Brookfield noted that at this time, no deal has been reached, and there's no guarantee that it and the other shareholders will make an offer. Grifols ADRs, which jumped more than 19% yesterday, added a further 0.8% to $8.48 as of 11:18 a.m. ET Tuesday. Despite the t ...