Q1 2019 war nicht gut. Sequentiell -15,6 % (zu Q4 2018) und YOY nur ein Zuwachs von 3,2 % (zu Q1 2018). Damit ist Q1 2019 eins von sechs Quartalen mit einem sequentiellen Sales-Rückgang, die nachfolgend orange gekennzeichnet sind.
Zeit, die Nerven zu verlieren? Nicht unbedingt. Wenn man möchte und ein bisschen genauer hinschaut, kann man das ganze etwas relativieren.
Die Direct Product Sales in Deutschland und in den anderen Direct-Sales-Ländern sind YOY um 16 % bzw. 18 % gewachsen. Währungsbereinigt (EURUSD) um 25 % bzw. 26 %.
Das ist zwar nicht brillant aber noch im Rahmen meiner Erwartungen, die in der unteren Range bei 25 % Sales-Wachstum p.a. liegen. Alles in allem derzeit aber kein Grund für Freudenluftsprünge.
Zum wohl ersten Mal gibt Dr. Chan eine Guidance für Q2 2019 basierend auf den ersten fünf Wochen des Quartals und annonciert das stärkste Quartalsergebnis überhaupt (und damit über 5,4 Mio USD an Sales Revenues). Inwieweit das nach fünf von zwölf Wochen in Q2 seriös ist, weiß ich (noch) nicht und wird sich Anfang August mit der Veröffentlichung der Q2-Zahlen offenbaren.
„CytoSorbents has not historically given specific financial guidance on quarterly results until the quarter has been completed. However, we expect second quarter 2019 product sales to return to our historical growth trajectory, and are anticipated to be the highest quarterly product sales reported in our history.
We also reiterate our guidance that we expect to achieve blended product gross margins that makes higher higher margin direct sales with lower margin distributor and partner sales of 80% on a quarterly basis this year.
The quarter is just a little over a third complete, however, when we look at our accounts both direct and distributors, we have fairly good visibility on what different accounts are going to do. I think that our sales people are in constant contact with their customers both on the international distributor and partner’s side as well as on the direct side, and so, because of that and because — I think that notwithstanding the three distributors that impacted Q1 results, direct sales continue to march forward. We expect to see a benefit from the investments that we’ve made in terms of headcount, in terms of expanding to new direct territories, in terms of our reimbursement, in terms of the strong market development that we’ve done and the strong key opinion leadership support that we have and the greater focus that our direct sales team will have as we narrow our sales territories. And so, I think that from a direct sales standpoint, we feel very encouraged by what we are seeing and expect to really begin to drive growth faster on the direct sales side.“
Derweil ein paar weitere Zitate aus dem Call:
„The German government, via the German Federal Ministry of Education and Research, is funding a 250 patient, multi-center randomized, controlled study
(“REMOVE”) using CytoSorb during valve replacement open heart surgery in patients with infective endocarditis. The study enrolled its first patient in January
2018. As of May 3, 2019, the trial had enrolled 180 patients at 15 sites.“
„In December 2017, the FDA approved our IDE application for our REFRESH 2-AKI study, permitting us to conduct this pivotal trial designed to provide the key
safety and efficacy data needed to support United States regulatory approval for CytoSorb in cardiac surgery, which we plan to pursue via the premarket approval
(PMA) pathway. The REFRESH 2-AKI trial is a randomized, controlled, multi-center, clinical trial designed to evaluate intraoperative CytoSorb use as a therapy
to reduce the incidence and severity of AKI, as measured by Kidney Disease Improving Global Outcomes (KDIGO) criteria, following complex cardiac surgery.
As of May 7, 2019, the trial had enrolled 79 patients. We anticipate that patient enrollment in the REFRESH 2-AKI trial will be complete by 2020, but this could
take longer if enrollment challenges or other factors causing delays are encountered. If the trial is successful, we plan to submit a PMA application in 2021.“
„From a clinical trial update standpoint, the U.S. REFRESH 2-AKI pivotal trial has now enrolled approximately 20% of its targeted 400 patients that it plans to enroll with currently now 79 patients enrolled. We currently have 23 initiated clinical sites with six additional sites in process. Enrollment rates have been increasing as new sites have ramped their activity. And we are targeting enrollment of 200 patients by the end of the first quarter of next year along with the beginning of an interim analysis.“
„And I am pleased to report on the HemoDefend pivotal trial, this is a point of care — HemoDefend is a point-of-care filter that removes noninfectious contaminants from transfused packed red blood cells, and the pivotal trial for the U.S. FDA approval is back on track for a second half of 2019 IDE submission. Clinical trial devices are being assembled. We have selected a contract research organization that is now conducting clinical site negotiations.“
Kommentar: die Anzahl der Patienten in der REMOVE-Studie steigt rasant. 70 Patienten fehlen noch. Denke, dass man hier in etwa drei Monaten durch ist und sich dann mit der Auswertung beschäftigen kann.
„Fresenius medical care is transitioning to new exclusive sales territories in Mexico, South Korea, and the Czech Republic and did not order in Q1 of 2019 as it sells through non-transferable European inventory. Once we achieve registration of CytoSorb in Mexico and South Korea and once European inventories are sold through, we expect new CytoSorb orders. Few other distributors temporarily paused from ordering to rebalance inventory, but have strong and growing end user demand for CytoSorb.“
„The good point is that we see end user usage and demand increasing in these territories. And importantly, we expect that the second quarter 2019 product sales to return to our historical growth trajectory and are anticipated to the highest quarterly product sales reported in our history. We are not relying on orders from these distributors to achieve this guidance.“
„Yes, I think that — what we have seen I think is that at least two of the distributors had gotten a little ahead of themselves and I think that they see continued, strong end-user demand in the marketplace and just wanted a temporary breather, I think, to work on some of their inventory before they start ordering again. And so again, these — both — all three distributors that we are talking about have made significant investments in CytoSorb, they continue to make significant investments in CytoSorb, and are quite aggressive about trying to establish these markets and build upon the markets that they’ve already developed. And so it’s more that — it’s not that the end-user demand is drying up, in fact, we believe, quite the opposite. But it’s just that the historical order pattern maybe was a little too aggressive for where they are at the moment. And they want to try to, I guess, grow into the end-user demand. So I think there are — but I think that from our perspective, they’ve been developing their respective markets very well, and we are optimistic that that balance will come in line soon.“
Kommentar: die Entscheidung, das Direct Sales Team zu verstärken, scheint objektiv richtig zu sein. Ich hoffe dennoch, dass sich die Partner-Sales wieder erholen.