Notable quotes and notes from November investor conferences.
ARQT, VRNA, SWTX, AVDL, APLS, EOLS.
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Here are some transcript notes I did myself from recent biotech investor conferences.
Companies covered: ARQT, VRNA, SWTX, EOLS, APLS, AVDL.
All thoughts presented in shorthand note format since I typed all this out with no transcript available and wanted to make it very accessible for quick reference.
Arcutis (ARQT) at Guggenheim, November 11th
“2024 has been a great year for us”…”January we got the approval for our foam for Seb Derm”…”the uptake of that was nothing short of spectacular, caught us by surprise, we were worried about running out at one point”…”that has continued to grow, throughout the year, in the fourth quarter you can see in the script trend very nice growth in the foam”…Atopic Derm “early signs on that launch as well are very encouraging, very good uptake, that’s continued on to Q4, feedback from clinicians have been very positive”…haven’t seen any impact from the primary care promotion yet…been growing 40%+ every quarter, anticipate maintaining a strong growth trajectory…”I know your banking team very well […] we do not need to come back to the marketplace to raise equity”…generally have to rely on high potency steroids to treat plaque psoriasis but not suitable for long-term use, seem good uptake in the psoriasis space, filed for approval of foam in scalp psoriasis, expect approval in May, will be another major catalyst to grow in space, half of psoriasis patients have scalp involvement, had 70% response rate at eight weeks, itch improvement within 24 hours, half of patients had no itch at all at Week 8, cream and foam in combination in psoriasis will be big drivers of growth…growing sentiment in Derm to move away from topical steroids because they have good options now…”we’ve been focused from the outset on driving paid prescriptions, not giving a bunch of drug away”…”we’re at the point where 4 out of 5 psoriasis scripts are paid for by insurance, 3 out of 4 foam scripts, and 3 months into launch 3 out of 5 AD scripts are being covered”…”we’ve been able to get gross to nets down to the low 50s which is a very credible performance for a retail product”…”75% of commercial lives covered, might go up slightly […] probably will never get to 100% coverage, big opportunity is Medicare and Medicaid”…Medicaid coverage in California, New York, Florida, Texas, Indiana, Michigan and Arizona…those seven states represent 43% of Medicaid lives…California kicked in November 1st…profitable business, making about as much on Medicaid as commercial business…Medicare coverage should kick in during 2025…partnered with Kowa for primary care…ZORYVE is very well suited to primary care…also will kick in during 2025…they are paid nothing unless there are scripts written that generate revenue, paid commission on revenue…”we’re paying for results, their interests are the same as our shareholders interest”…look at rolling four week average for script growth…”huge opportunity in dermatologist opportunity alone”…new indications, expansion into Medicare/Medicaid, shift from topical steroids…”16 times as many steroid scripts written for our three indications than all of the other branded non-steroidal agents combined”…these are patients already in the office, already receiving topical therapy…cost of current pipeline is baked into profitability timeline…major inflections next year for both major pipeline programs…
Verona Pharma (VRNA) at Jefferies London, November 19th
“Great traction, over 5,000 scripts being filled, over 2,200 prescribers, breadth of prescribing across all types of COPD patients”…very pleased…advancing two Phase 2 trials for lifecycle management…novel mechanism of action…relatively little innovation over several decades in COPD…physicians and patients were looking for something additional…thing we heard in market research over two years was unmet need, chronic progressive disease with declining function and increasing symptoms…Doctors have responded as market research anticipated to an agent with additional broncodilation, additional non-steroidal anti-inflammatory effects…sustainable…just 1% of the COPD population could lead to just over a billion dollars in revenue…would not give guidance for Q4 but did not push back to a $18 million+ assumption…using specialty network with pharmacies constantly in contact with patients can provide additional support or adherence reminders…”we stay incredibly focused on new patients, deeping the prescriber base, we have more prescribers every week”…”once a prescriber writes a prescription, they tend to write more prescriptions over time”…”when a patient comes back into the office and tells the physician how they fell on Ohtuvayre that helps those physicians move in addition to our rep interactions”…starting direct to patient activities…“launch is going extremely well, we don’t see any slow down”…”we know patients on triple [therapy] who are symptomatic have very few options and because the benefit to risk of Ohtuvayre is so compelling we see physicians wanting to use it in those patients as well”…[Is this going to be the strongest COPD launch in history?] “It already is”…”on the reimbursement side it’s been consistent with what we expected”…”vast majority of our prescriptions are paid prescriptions”…cash flow breakeven can be achieved at $250 million to $300 million/year run rate…looking at respiratory and pulmonary space broadly for business development…
SpringWorks Therapeutics (SWTX) at Jefferies, November 19th
“Everything we have seen and will share with you today gives us confidence in the aggregate size of the opportunity [in desmoid tumors]”…[on NF1-PN] “we have data that we believe is best in class for children and first in class for adults”…we shared for the first time [on earnings call] […] we have had over 10,000 unique claims [through ICD-10 code] for desmoid tumors in less than a year…1,600 to 1,700 new incident patients per year…if you go to get diagnosed with desmoid tumor you are dealing with a symptom (e.g. pain, restriction of motion), that’s why you went to get diagnosis…estimate 90% over course of lives will get treated…physician enthusiasm is high…uniformly strong, only approved treatment…70% market share of new Rxs…95% of doctors using again, 90% say they will use in frontline, 60% say they will use it more next year…”pain is actually in our label, if they have a symptomology related to pain that’s enough to prescribe”…OLE data from Phase 3 indicates continued improvement across three years with no change in AE profile…price is $29,000/month and coverage of 95% of covered lives that we are on policy for…less than 10% penetrated in the opportunity…should get meaningful portion of newly diagnosed patients…treatment algorithm before was watchful waiting then surgery or off-label meds…expectation is all patients will eventually be treated…median patient in Phase 3 had failed four prior lines of treatment…40% of patients dose reduce, blister pack ensures flat pricing now…[editor note: essentially a 16% price increase with the transition, shared math on Twitter]…re: safety signals, discontinuation rate is less than 10%, discontinuations are usually early…commercial d/c rate is slightly better than clinical trial rate…not worried about competition, no differentiation, less long-term data, late to market with most patients satisfied on therapy…Multiple Myeloma treatment questions, gamma secretase inhibitors can prevent BCMA cleaving, allowing more available target, less off-target effects…multiple bispecific players will have to differentiate in some way…pipeline expansion Q on ovarian granulosa cell tumors, bar is very low post-platinum salvage treatment…data in first half of next year, might run Phase 3 or maybe can get on guidelines with Phase 2, will wait for data…conversation switches to MEK inhibitor for NF1-PN…management pointing to size of opportunity there too…AstraZeneca has drug in children already doing $500m runrate…reiterates best in class for children (1/4 of opportunity) and first in class for adults (3/4 of opportunity)…positioned well, expect to launch in U.S. soon after approval…2025 is three launches…Ogsiveo for Desmoid outside of U.S., U.S. launch for mirdametinib in NF1-PN, ex-U.S. launch for mirdametinib…think there are many treatment-experienced children looking to get back on drug for MEK inhibitor…think AZ will be approved in adults but think they will have head start and best in class molecule…asked about partnering ex-U.S. for mirdametinib specifically…believe they can win on data versus AstraZeneca and have opportunities to partner…will do whatever’s right for patients.
Avadel (AVDL) at Jefferies, November 20th
First question about differentiation against twice nightly agents…narcolepsy 24/7 condition with disrupted sleep and sleep paralysis…”only treatment available that both addresses daytime symptoms without disrupting the night”…continuing to execute launch, continuing to execute lifecycle management, dealing with legal matters and derisking…update on court cases…reiterating three buckets: switch patients (14,000 left, over 16,000 in past), previously failed oxybate patients (10,000 to 15,000 patients), new to oxybate potential patients (3,000 to 4,000 each year, possibly more if new prescribers and patient types consider oxybates)…significant opportunity to grow…at 2,300 patients in 5th quarter of launch…need around 8,000 reimbursed patients on therapy to reach blockbuster status…
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