voda schreef op 13 mei 2023 10:00:
Wat meer toelichting op de cijfers:
Jeroen Wakkerman – Chief Executive Officer:
Yeah, thank you very much, Steve. And good morning, good afternoon. As -- next slide please.
As Steve mentioned earlier, as you can see on this slide, the first quarter results were lower. And
that was due to the HAE market factors which impacted on the entire industry. And those industrywide factors have since resolved and we can confirm that we have truly recovered. And if we look
at the quarter January was in line with last year, and February is where we faced headwinds. March
had a strong recovery, and so had April. We've almost made up all of the shortfall and expect to
recover the remainder. We therefore continue to expect single digit growth in RUCONEST®
revenues for 2023.
And on the slide, you see that the revenues in Q1 were 42.5 million, that's 9 percent down on last
year for the reasons I mentioned. Gross Profit developed in line with that it went down by 8 percent
to 38.5 million and the operating costs increased from 40 million to almost 53 million and that was
on the back of leniolisib both in R&D investments and sales and marketing costs. Operating profit
and net profit reduced, and the operating loss was 13.7 million and a net loss of 12.2 million. So,
the short of this quarter is that the sales shifted from Q1 to, Q2 And we've seen that in April. And
with regards to costs, we're investing in leniolisib. And obviously, we haven't recorded any
revenues in Q1 yet for leniolisib or Joenja®. But that will change in Q2. But then go to the next
slide, please.
On the cost development, you'll see that we are continuing to invest in a launch of Joenja®. If you
looked at the longer-term trends over the quarters that are shown here starting with the R&D
brackets at the bottom, we see a reduction in quarterly R&D costs in Q2, and that is because of
reduced investment in a transgenic platform. And you see an uptick again in Q1 this year, because
of leniolisib. Looking at the G&A general and admin costs and developments, we've seen a slight
growth per quarter of the last quarters, which basically means investment ahead of company
growth. Q1 2023 was higher than the last year, but lower than previous years. And the big number
in Q4 by the way to 17.6 that you see is because of an impairment cost of a building. So, that's not
a repetitive cost. The marketing and sales cost is the biggest bracket we've seen a quarterly growth
of marketing and sales cost in 2022 With more investments in the Joenja® launch, especially
obviously in Q4 last year. And I should note that the marketing and sales expenses for your U.S.
launch are high in this period, also in Q3. And going forward, we will see an increase in marketing
and sales costs in other key markets, namely Europe and the U.K., in the trading quarters as we
prepare for launch. To get an indication of OPEX levels for the remainder of the year and therefore
for full year the Q4 of 2022 and the Q1 2023 OPEX levels are good indicators, albeit it may increase
moderately. If we then go to the next slide.
It's about the cash flow. The cash went down from 207 million to 185 million at the end of Q1. And
the key reason is the net cash flows used in operating activities. The cash loss was 10.2 million from
operations, working capital increased by 12 million. And that was mainly because of an increase in
Q2 and that is -- the latter was because of phasing. The cash flow used in financing activities is due
to irregular interest and lease costs and we have some positive foreign exchange effects, bringing
the cash to the $185 million. Then the outlook on the next slides.
We continue to expect low single digit growth in RUCONEST® revenues for the full year. Joenja®
was approved in the first quarter on the 24th of March by the FDA and we have been
commercializing in the U.S. since early April 2023. We are expecting Europe a positive CHMP
opinion in the second half of this year, and the marketing authorization to follow approximately
two months later. Subject to the positive outcome of the CHMP review we will file for U.K. approval
with the MHRA. We will continue to invest in future growth and to accelerate it and that will
obviously be focused on the Joenja® launch. And we will provide further details of our plans to
develop leniolisib in additional indications in the second half of this year. And to finish off with we
will continue to look for late-stage opportunities and rare diseases be it in in-licensing or in potential
acquisitions. So, we're still open for investments very much in that area.
With that, this concludes the presentation, and I would like to go to the next slide and open up for
questions and answers to any of them of the people attending the call from the Pharming side.
Thank you very much.
Bladzijde 7/8:
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