{"id":93656,"date":"2024-08-13T07:42:13","date_gmt":"2024-08-13T05:42:13","guid":{"rendered":"https:\/\/www.formycon.com\/blog\/2024\/08\/13\/h1-24-interview-mit-dem-vorstand\/"},"modified":"2025-03-20T17:54:50","modified_gmt":"2025-03-20T16:54:50","slug":"h1-24-an-interview-with-our-executive-board","status":"publish","type":"post","link":"https:\/\/www.formycon.com\/en\/blog\/2024\/08\/13\/h1-24-an-interview-with-our-executive-board\/","title":{"rendered":"An interview with our Executive Board"},"content":{"rendered":"

[vc_row][vc_column column_width_use_pixel=”yes” align_horizontal=”align_center” gutter_size=”3″ font_family=”font-130579″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/1″ uncode_shortcode_id=”279312″ column_width_pixel=”800″][vc_custom_heading text_font=”font-126351″ text_transform=”uppercase” sub_lead=”small” uncode_shortcode_id=”342044″ subheading=”13. August 2024″]<\/p>\n

An Interview with our Executive Board<\/h2>\n

[\/vc_custom_heading][\/vc_column][\/vc_row][vc_row row_height_percent=”0″ override_padding=”yes” h_padding=”2″ top_padding=”2″ bottom_padding=”0″ overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ uncode_shortcode_id=”160712″][vc_column column_width_use_pixel=”yes” gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/1″ uncode_shortcode_id=”148088″ column_width_pixel=”800″ css=”.vc_custom_1729250724356{padding-bottom: -36px !important;}”][vc_column_text uncode_shortcode_id=”185136″]Formycon is regarded as a \u201cpure play\u201d biosimilars company. What exactly does this mean? <\/span><\/strong><\/em>[\/vc_column_text][vc_row_inner row_inner_height_percent=”0″ back_color=”color-106894″ back_image=”92382″ overlay_alpha=”50″ gutter_size=”3″ shift_y=”0″ z_index=”0″ uncode_shortcode_id=”473703″ back_color_type=”uncode-palette”][vc_column_inner column_width_percent=”100″ position_vertical=”middle” gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/2″ uncode_shortcode_id=”459286″ css=”.vc_custom_1729242387364{padding-top: 30px !important;padding-right: 15px !important;padding-bottom: 30px !important;padding-left: 30px !important;}”][vc_single_image media=”92376″ media_width_percent=”100″ uncode_shortcode_id=”278374″][\/vc_column_inner][vc_column_inner column_width_percent=”100″ position_vertical=”bottom” gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/2″ uncode_shortcode_id=”197839″ css=”.vc_custom_1729242474423{padding-top: 30px !important;padding-right: 30px !important;padding-bottom: 20px !important;padding-left: 15px !important;}”][vc_column_text uncode_shortcode_id=”374462″]Dr. Stefan Glombitza<\/strong>
\nChief Executive Officer (CEO)
\nFormycon AG[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_column_text uncode_shortcode_id=”118739″]Dr. Stefan Glombitza, Chief Executive Officer:<\/strong> \u201eFormycon is a globally operating, independent specialist in the development of biosimilar drugs. We aim to firmly establish our company as leader in the growing biosimilars segment and partner of choice for the major pharmaceutical names with their strength and reach in sales and marketing. For us, being a \u201cpure play\u201d specialist means complete and absolute focus on our capabilities and excellence spanning all phases of biosimilars development, from the process of selecting biosimilar candidates all the way through to regulatory approval.\u201c[\/vc_column_text][\/vc_column][\/vc_row][vc_row row_height_percent=”0″ override_padding=”yes” h_padding=”2″ top_padding=”2″ bottom_padding=”0″ overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ uncode_shortcode_id=”162456″][vc_column column_width_use_pixel=”yes” gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/1″ uncode_shortcode_id=”327525″ column_width_pixel=”800″][vc_column_text uncode_shortcode_id=”161613″]What makes you so confident that biosimilars are a growth market?<\/span><\/strong><\/em>[\/vc_column_text][vc_column_text uncode_shortcode_id=”134484″]Stefan Glombitza:<\/strong> \u201eThree reasons: firstly, the vast combined market size of the biologics which will lose their market exclusivity over the next few years; secondly, the large and ever increasing need for doctors to be able to effectively treat patients; and thirdly, the growing financial strains on the world\u2019s healthcare systems. Because of the high cost of many biologics, it remains true even today that too few patients are being treated with these highly effective drugs at a sufficiently early disease stage. Biosimilars, with their comparable efficacy, represent a cost-effective solution to this global problem. Biosimilars can provide the financial relief so that as many patients as possible can receive the optimal therapy as early as possible. The \u201cgold standard\u201d for treating serious diseases should not be reserved for just the privileged few.\u201c[\/vc_column_text][\/vc_column][\/vc_row][vc_row row_height_percent=”0″ override_padding=”yes” h_padding=”2″ top_padding=”2″ bottom_padding=”0″ overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ uncode_shortcode_id=”348071″][vc_column column_width_use_pixel=”yes” gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/1″ uncode_shortcode_id=”327525″ column_width_pixel=”800″][vc_column_text uncode_shortcode_id=”338167″]Can you give us an example of a disease for which medical needs are not currently being fully met because there is, in fact, an undersupply of biologics?<\/span><\/strong><\/em>[\/vc_column_text][vc_column_text uncode_shortcode_id=”155662″]Stefan Glombitza:<\/strong> \u201eOne of many examples is Crohn\u2019s disease, a chronic inflammatory bowel disorder. Even in a rich country like Germany, only about 15% of Crohn\u2019s patients are currently being treated with highly effective biologics.1<\/sup> In the acute phases of Crohn\u2019s disease, severe inflammatory symptoms often occur for periods of several weeks, severely impacting quality of life for those afflicted, including tremendous psychological stress. The treatment option is there, but it is being used too rarely. We want to change this – in this specific case with FYB202, our candidate biosimilar to Stelara\u00ae2<\/sup>, for which we expect EU approval shortly following the CHMP\u2019s positive recommendation.3<\/sup> As biosimilars like our FYB202 enter the market, competition increases, costs fall, and patient care improves.\u201c[\/vc_column_text][\/vc_column][\/vc_row][vc_row row_height_percent=”0″ override_padding=”yes” h_padding=”2″ top_padding=”2″ bottom_padding=”0″ overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ uncode_shortcode_id=”348071″][vc_column column_width_use_pixel=”yes” gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/1″ uncode_shortcode_id=”327525″ column_width_pixel=”800″][vc_column_text uncode_shortcode_id=”162874″]Formycon announced quite a number of development advances over the first six months of this year. Which of these were the highlights for you? <\/span><\/strong><\/em>[\/vc_column_text][vc_column_text uncode_shortcode_id=”117589″]Stefan Glombitza:<\/strong> \u201eAt the start of the year, we said: In 2024 we will lay the foundation for the next phase of Formycon\u2019s growth, which will lead us to sustainable profitability over the medium term, through the approval of biosimilars and preparations for their market launch by early 2025. We\u2019re on track for this.<\/p>\n

A particular highlight is certainly the FDA\u2019s4<\/sup> approval of FYB203, our biosimilar to Eylea\u00ae5<\/sup>. With this approval for the U.S. market of FYB203 \u2013 which, like our FYB201 product, can be used to treat serious retinal diseases such as \u201cwet\u201d age-related macular degeneration and various diabetes-related diseases \u2013 we are now even more strongly positioned in the ophthalmology sector.\u201c[\/vc_column_text][\/vc_column][\/vc_row][vc_row row_height_percent=”0″ override_padding=”yes” h_padding=”2″ top_padding=”2″ bottom_padding=”0″ overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ uncode_shortcode_id=”348071″][vc_column column_width_use_pixel=”yes” gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/1″ uncode_shortcode_id=”327525″ column_width_pixel=”800″][vc_column_text uncode_shortcode_id=”185118″]What about Formycon\u2019s other biosimilar development projects?
\n<\/span><\/strong><\/em>[\/vc_column_text][vc_column_text uncode_shortcode_id=”900880″]Stefan Glombitza:<\/strong> \u201eWe\u2019re coming along very well and in some cases are making progress even faster than anticipated. With the launch of clinical trials in June, we hope to secure a strong market position for FYB206, our candidate biosimilar to Keytruda\u00ae6<\/sup>. As a biosimilar to the world\u2019s top-selling drug, the economic importance of this project can hardly be overstated. We see enormous future demand.<\/p>\n

As to the FYB202 project which I mentioned before, we expect EU approval as early as the beginning of the fourth quarter of 2024, a few weeks ahead of our original plan, due in no small part to the superb work and quick response times of our development teams. In the United States, we likewise expect FDA approval for FYB202 around the end of September. In addition, we hope to begin work on FYB210, a new biosimilar candidate, in the second half of the year. In other words, you can look forward to more positive news from Formycon over the coming weeks and months.\u201c[\/vc_column_text][\/vc_column][\/vc_row][vc_row row_height_percent=”0″ override_padding=”yes” h_padding=”2″ top_padding=”2″ bottom_padding=”0″ overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ uncode_shortcode_id=”160712″][vc_column column_width_use_pixel=”yes” gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/1″ uncode_shortcode_id=”148088″ column_width_pixel=”800″ css=”.vc_custom_1729250724356{padding-bottom: -36px !important;}”][vc_column_text uncode_shortcode_id=”279450″]Dr. Glombitza mentioned the economic importance of FYB206 to Formycon. What more can you tell us about this? <\/span><\/strong><\/em>[\/vc_column_text][vc_row_inner row_inner_height_percent=”0″ back_color=”color-106894″ back_image=”92382″ overlay_alpha=”50″ gutter_size=”3″ shift_y=”0″ z_index=”0″ uncode_shortcode_id=”473703″ back_color_type=”uncode-palette”][vc_column_inner column_width_percent=”100″ position_vertical=”bottom” align_horizontal=”align_right” gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/2″ uncode_shortcode_id=”156927″ css=”.vc_custom_1729251361281{padding-top: 30px !important;padding-right: 15px !important;padding-bottom: 20px !important;padding-left: 30px !important;}”][vc_column_text uncode_shortcode_id=”163640″]Dr. Andreas Seidl<\/strong>
\nChief Scientific Officer (CSO)
\nFormycon AG[\/vc_column_text][\/vc_column_inner][vc_column_inner column_width_percent=”100″ position_vertical=”middle” gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/2″ uncode_shortcode_id=”197263″ css=”.vc_custom_1729251394319{padding-top: 30px !important;padding-right: 30px !important;padding-bottom: 30px !important;padding-left: 15px !important;}”][vc_single_image media=”92399″ media_width_percent=”100″ alignment=”center” uncode_shortcode_id=”213540″][\/vc_column_inner][\/vc_row_inner][vc_column_text uncode_shortcode_id=”113214″]Dr. Andreas Seidl, Chief Scientific Officer:<\/strong> \u201eWith this entry into immuno-oncology, we are opening up an area of active ingredients with extraordinarily large market potential. The IARC7<\/sup> expects that worldwide cancer cases will continue to increase sharply in the future. The demand for these modern therapies is immense \u2013 so there\u2019s a good reason why so many biosimilars are being developed for cancer treatment.\u201c[\/vc_column_text][\/vc_column][\/vc_row][vc_row row_height_percent=”0″ override_padding=”yes” h_padding=”2″ top_padding=”2″ bottom_padding=”0″ overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ uncode_shortcode_id=”160712″][vc_column column_width_use_pixel=”yes” gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/1″ uncode_shortcode_id=”148088″ column_width_pixel=”800″ css=”.vc_custom_1729250724356{padding-bottom: -36px !important;}”][vc_column_text uncode_shortcode_id=”125488″]How can FYB206 help cancer patients?<\/span><\/strong><\/em>[\/vc_column_text][vc_column_text uncode_shortcode_id=”189514″]Andreas Seidl:<\/strong> \u201eWith FYB206, or pembrolizumab, we are developing a candidate biosimilar that works by activating the body\u2019s own immune response to fight the tumor. This is a highly promising approach for numerous cancer indications, notably including non-small cell lung cancer and melanoma, a particularly aggressive form of skin cancer. These are, in fact, the two specific indications for which we are currently conducting our clinical trials.\u201c[\/vc_column_text][\/vc_column][\/vc_row][vc_row row_height_percent=”0″ override_padding=”yes” h_padding=”2″ top_padding=”2″ bottom_padding=”0″ overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ uncode_shortcode_id=”160712″][vc_column column_width_use_pixel=”yes” gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/1″ uncode_shortcode_id=”148088″ column_width_pixel=”800″ css=”.vc_custom_1729250724356{padding-bottom: -36px !important;}”][vc_column_text uncode_shortcode_id=”130979″]Top-selling reference drugs generally mean a lot of potential competitors in the biosimilars market space. Where do you see Formycon in this competition?
\n<\/span><\/strong><\/em>[\/vc_column_text][vc_column_text uncode_shortcode_id=”110024″]Andreas Seidl:<\/strong> \u201eThe start of clinical trials is a good indicator for comparing our own development progress to that of our competitors. All in all, we can be very satisfied by this metric because it means that we are in the leading tier of biosimilar developers, particularly within the target markets of the United States and Europe.\u201c[\/vc_column_text][\/vc_column][\/vc_row][vc_row row_height_percent=”0″ override_padding=”yes” h_padding=”2″ top_padding=”2″ bottom_padding=”0″ overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ uncode_shortcode_id=”160712″][vc_column column_width_use_pixel=”yes” gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/1″ uncode_shortcode_id=”148088″ column_width_pixel=”800″ css=”.vc_custom_1729250724356{padding-bottom: -36px !important;}”][vc_column_text uncode_shortcode_id=”137340″]So both of these clinical trials are already in progress?<\/span><\/strong><\/em>[\/vc_column_text][vc_column_text uncode_shortcode_id=”661096″]Andreas Seidl:<\/strong> \u201eYes, the two clinicals studies are being conducted in parallel across several centers in Eastern Europe and Southeast Asia. In mid-June, we launched the Dahlia phase I study, comparing the pharmacokinetics, safety and tolerability of FYB206 with the reference drug Keytruda\u00ae. Study participants are patients who have had a malignant melanoma surgically removed.<\/p>\n

For the Lotus phase III study, we recruited patients with non-small cell lung cancer and began the actual clinical trials starting from the end of July. The Lotus study compares the safety and efficacy of FYB206 to its reference drug Keytruda\u00ae.[\/vc_column_text][\/vc_column][\/vc_row][vc_row row_height_percent=”0″ override_padding=”yes” h_padding=”2″ top_padding=”2″ bottom_padding=”0″ overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ uncode_shortcode_id=”160712″][vc_column column_width_use_pixel=”yes” gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/1″ uncode_shortcode_id=”148088″ column_width_pixel=”800″ css=”.vc_custom_1729250724356{padding-bottom: -36px !important;}”][vc_column_text uncode_shortcode_id=”238803″]I know that a lot is also happening in the area of commercialization. What are Formycon\u2019s current priorities?
\n<\/span><\/strong><\/em>[\/vc_column_text][vc_row_inner row_inner_height_percent=”0″ back_color=”color-106894″ back_image=”92382″ overlay_alpha=”50″ gutter_size=”3″ shift_y=”0″ z_index=”0″ uncode_shortcode_id=”473703″ back_color_type=”uncode-palette”][vc_column_inner column_width_percent=”100″ position_vertical=”middle” gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/2″ uncode_shortcode_id=”459286″ css=”.vc_custom_1729242387364{padding-top: 30px !important;padding-right: 15px !important;padding-bottom: 30px !important;padding-left: 30px !important;}”][vc_single_image media=”92395″ media_width_percent=”100″ uncode_shortcode_id=”152867″][\/vc_column_inner][vc_column_inner column_width_percent=”100″ position_vertical=”bottom” gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/2″ uncode_shortcode_id=”197839″ css=”.vc_custom_1729242474423{padding-top: 30px !important;padding-right: 30px !important;padding-bottom: 20px !important;padding-left: 15px !important;}”][vc_column_text uncode_shortcode_id=”321386″]Nicola Mikulcik<\/strong>
\nChief Business Officer (CBO)
\nFormycon AG[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_column_text uncode_shortcode_id=”192728″]Nicola Mikulcik, Chief Business Officer:<\/strong> \u201eOur FYB201 product, the biosimilar to Lucentis\u00ae8<\/sup>, also known as ranibizumab, is already available in 19 countries worldwide. In the United States and various other markets, we are pleased with the very good market penetration we\u2019ve already achieved, and we are clearly leading in ranibizumab biosimilars. And the market launches are continuing: Most recently, we were able to announce the launch in Saudi Arabia through our commercialization partner MS Pharma. Further approvals and product launches are planned through to 2026, with a particular regional focus on Middle Eastern and Latin American markets.\u201c[\/vc_column_text][\/vc_column][\/vc_row][vc_row row_height_percent=”0″ override_padding=”yes” h_padding=”2″ top_padding=”2″ bottom_padding=”0″ overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ uncode_shortcode_id=”160712″][vc_column column_width_use_pixel=”yes” gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/1″ uncode_shortcode_id=”148088″ column_width_pixel=”800″ css=”.vc_custom_1729250724356{padding-bottom: -36px !important;}”][vc_column_text uncode_shortcode_id=”451601″]How have the European markets been developing?<\/span><\/strong><\/em>[\/vc_column_text][vc_column_text uncode_shortcode_id=”114908″]Nicola Mikulcik:<\/strong> \u201eWe are working hard to further expand our market share within Europe. The introduction of pre-filled syringes to complement the currently available vials will play a key role in these efforts. This more convenient dosage form should be available to doctors and eye clinics over the course of the coming year.\u201c[\/vc_column_text][\/vc_column][\/vc_row][vc_row row_height_percent=”0″ override_padding=”yes” h_padding=”2″ top_padding=”2″ bottom_padding=”0″ overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ uncode_shortcode_id=”160712″][vc_column column_width_use_pixel=”yes” gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/1″ uncode_shortcode_id=”148088″ column_width_pixel=”800″ css=”.vc_custom_1729250724356{padding-bottom: -36px !important;}”][vc_column_text uncode_shortcode_id=”932237″]FYB202 and FYB203 are both approaching the commercialization stage. What are the next steps as you prepare for market introduction?<\/span><\/strong><\/em>[\/vc_column_text][vc_column_text uncode_shortcode_id=”679222″]Nicola Mikulcik:<\/strong> \u201eIn the case of FYB202, our candidate biosimilar to Stelara\u00ae, we\u2019re focusing on the initial market launches together with our marketing partner Fresenius Kabi and working hard to ensure that the product is available in sufficient quantities starting with the United States and Europe.<\/p>\n

For our second ophthalmology biosimilar, FYB203, our partner and license holder Klinge Biopharma has concluded an exclusive license and supply agreement with MS Pharma for marketing in the MENA region. MS Pharma is very well positioned throughout this region and has already been successfully introducing our FYB201 product in these markets.<\/p>\n

As to the United States and Europe, we expect to conclude corresponding agreements with strong commercialization partners in the second half of the year.\u201c[\/vc_column_text][\/vc_column][\/vc_row][vc_row row_height_percent=”0″ override_padding=”yes” h_padding=”2″ top_padding=”2″ bottom_padding=”0″ overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ uncode_shortcode_id=”160712″][vc_column column_width_use_pixel=”yes” gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/1″ uncode_shortcode_id=”148088″ column_width_pixel=”800″ css=”.vc_custom_1729250724356{padding-bottom: -36px !important;}”][vc_column_text uncode_shortcode_id=”141435″]How is 2024 looking so far from a financial perspective?<\/span><\/strong><\/em>[\/vc_column_text][vc_row_inner row_inner_height_percent=”0″ back_color=”color-106894″ back_image=”92382″ overlay_alpha=”50″ gutter_size=”3″ shift_y=”0″ z_index=”0″ uncode_shortcode_id=”473703″ back_color_type=”uncode-palette”][vc_column_inner column_width_percent=”100″ position_vertical=”bottom” align_horizontal=”align_right” gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/2″ uncode_shortcode_id=”156927″ css=”.vc_custom_1729251361281{padding-top: 30px !important;padding-right: 15px !important;padding-bottom: 20px !important;padding-left: 30px !important;}”][vc_column_text uncode_shortcode_id=”146443″]Enno Spillner<\/strong>
\nChief Financial Officer (CFO)
\nFormycon AG[\/vc_column_text][\/vc_column_inner][vc_column_inner column_width_percent=”100″ position_vertical=”middle” gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/2″ uncode_shortcode_id=”197263″ css=”.vc_custom_1729251394319{padding-top: 30px !important;padding-right: 30px !important;padding-bottom: 30px !important;padding-left: 15px !important;}”][vc_single_image media=”92397″ media_width_percent=”100″ alignment=”center” uncode_shortcode_id=”148650″][\/vc_column_inner][\/vc_row_inner][vc_column_text uncode_shortcode_id=”462085″]Enno Spiller, Chief Financial Officer:<\/strong> \u201eThe entry of Gedeon Richter as a strategic investor at the start of the year was a major statement of confidence. For us, this was not only a big success as a transaction but also a validation of our growth path and remarkable achievements over the past few years.
\nThe cash inflow from this transaction of roughly \u20ac 83 million has made a significant contribution to our capacity to continue pushing forward with our biosimilar development projects, particularly FYB206, at a consistently rapid pace while also ensuring the highest quality standards.\u201c[\/vc_column_text][\/vc_column][\/vc_row][vc_row row_height_percent=”0″ override_padding=”yes” h_padding=”2″ top_padding=”2″ bottom_padding=”0″ overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ uncode_shortcode_id=”160712″][vc_column column_width_use_pixel=”yes” gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/1″ uncode_shortcode_id=”148088″ column_width_pixel=”800″ css=”.vc_custom_1729250724356{padding-bottom: -36px !important;}”][vc_column_text uncode_shortcode_id=”634300″]In the case of two biosimilar candidates, development is almost complete. What are your expectations for FYB202 and FYB203? <\/span><\/strong><\/em>[\/vc_column_text][vc_column_text uncode_shortcode_id=”370361″]Enno Spillner:<\/strong> \u201eAs of now, we are fully on schedule with all of our development projects and are looking forward to the launch of FYB202, our candidate biosimilar to Stelara\u00ae, in 2025. Once the global market launch by our commercialization partner Fresenius Kabi is complete, FYB202 will significantly increase Formycon\u2019s sales revenue and help us attain sustainable EBITDA profitability over the medium term. The settlement agreements with Johnson & Johnson have paved the way not only for the U.S. market but also, more recently, for the European and Canadian markets.<\/p>\n

We cannot currently give a specific launch date for FYB203, as no agreement has yet been reached with Regeneron, the manufacturer of the reference drug.\u201c[\/vc_column_text][\/vc_column][\/vc_row][vc_row row_height_percent=”0″ override_padding=”yes” h_padding=”2″ top_padding=”2″ bottom_padding=”0″ overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ uncode_shortcode_id=”160712″][vc_column column_width_use_pixel=”yes” gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/1″ uncode_shortcode_id=”148088″ column_width_pixel=”800″ css=”.vc_custom_1729250724356{padding-bottom: -36px !important;}”][vc_column_text uncode_shortcode_id=”181332″]You\u2019ve just issuance an upward revision to your guidance for fiscal year 2024. This is certainly a very positive signal. What were the triggers?<\/span><\/strong><\/em>[\/vc_column_text][vc_column_text uncode_shortcode_id=”518209″]Enno Spillner:<\/strong> \u201eOur current 2024 operating figures are looking good, and everything is going according to plan. Sales and EBITDA are expected to remain within the forecast range. We were pleased to be able to announce a significant upward adjustment to our Adjusted EBITDA forecast due to better-than-expected results from sales of FYB201, which are reported through our investment participation in the Bioeq AG joint venture. These ongoing earnings will make a sustained contribution to our company\u2019s success.\u201c[\/vc_column_text][\/vc_column][\/vc_row][vc_row row_height_percent=”0″ override_padding=”yes” h_padding=”2″ top_padding=”2″ bottom_padding=”0″ overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ uncode_shortcode_id=”160712″][vc_column column_width_use_pixel=”yes” gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/1″ uncode_shortcode_id=”148088″ column_width_pixel=”800″ css=”.vc_custom_1729250724356{padding-bottom: -36px !important;}”][vc_column_text uncode_shortcode_id=”655628″]In summary, it\u2019s clear from everything you\u2019ve said that the first half of 2024 was very successful. Would you say that the path to future success is also clear?
\n<\/span><\/strong><\/em>[\/vc_column_text][vc_column_text uncode_shortcode_id=”462579″]Dr. Stefan Glombitza:<\/strong> \u201eOur path to becoming a globally leading, independent, pure-play biosimilars specialist is supported by a deep personal commitment from the entire #TeamFormycon. This extends to the members of the Supervisory Board with their extensive industry experience not only in Germany but internationally.<\/p>\n

On this subject, I would like to once again extend our deepest gratitude to Dr. Olaf Stiller and Peter Wendeln, the two Supervisory Board members who stepped down in June after having done so much to help us to reach where we are today. With remaining members Wolfgang Essler and Klaus R\u00f6hrig as well as newly elected members Dr. Bodo Coldewey and Nick Haggar, along with Colin Bond starting from October 2024, we aim to continue Formycon\u2019s successful path but with an increasingly international orientation.<\/p>\n

On behalf of the Executive Board, I would like to specially thank our employees. Without the extraordinary efforts of the entire team, the many remarkable successes achieved during the first half of 2024 would not have been possible. We are also grateful to our shareholders for their continued confidence in Formycon and in the work that we do.\u201c[\/vc_column_text][\/vc_column][\/vc_row][vc_row row_height_percent=”0″ override_padding=”yes” h_padding=”2″ top_padding=”2″ bottom_padding=”0″ overlay_alpha=”50″ gutter_size=”3″ column_width_percent=”100″ shift_y=”0″ z_index=”0″ uncode_shortcode_id=”160712″][vc_column column_width_use_pixel=”yes” gutter_size=”3″ overlay_alpha=”50″ shift_x=”0″ shift_y=”0″ shift_y_down=”0″ z_index=”0″ medium_width=”0″ mobile_width=”0″ width=”1\/1″ uncode_shortcode_id=”148088″ column_width_pixel=”800″ css=”.vc_custom_1729250724356{padding-bottom: -36px !important;}”][vc_column_text uncode_shortcode_id=”210112″]Thank you for taking the time to speak with us!<\/span><\/strong><\/em>[\/vc_column_text][vc_empty_space empty_h=”2″][vc_separator sep_color=”” uncode_shortcode_id=”854998″][vc_column_text text_lead=”small” uncode_shortcode_id=”822152″ el_class=”literatur”]<\/p>\n

    \n
  1. Baumgart, Misery, Naeyaert, Taylor: Biological Therapies in Immune-Mediated Inflammatory Diseases: Can Biosimilars Reduce Access Inequities?<\/li>\n
  2. Stelara\u00ae is a registered trademark of Johnson & Johnson<\/li>\n
  3. \n
    The opinion of the Committee for Medicinal Products for Human Use (CHMP)\u00a0of the EMA is the basis for the European Commission’s marketing authorization decision<\/div>\n<\/li>\n
  4. US regulatory authority \u2013 U.S. Food and Drug Administration<\/li>\n
  5. Eylea\u00ae is a registered trademark of Regeneron Pharmaceuticals Inc.<\/li>\n
  6. Keytruda\u00ae is a registered trademark of Merck Sharp & Dohme LLC.<\/li>\n
  7. IARC \u2013 International Agency for Research on Cancer<\/li>\n
  8. Lucentis\u00ae is aregistered trademark of Genentech Inc.<\/li>\n<\/ol>\n

    [\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"

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