Spectrum Pharmaceutecals Inc (SPPI)

[dcaf7]

Nice short review on G-CSFs including Eflapegrastim.
https://www.uspharmacist.com/article/prevention-and-treatment-of-chemotherapyinduced-febrile-neutropenia-in-adults
I didn't realise that Efla has two serine substitutions at positions 17 and 65 as compared to human G-CSF. Good to know that two components of Efla are produced in E.coli, not in mamalian cells.

[dcaf7]

Hanmi Pharm to unveil new drug pipelines at AACR 2023.
The new pipelines that Hanmi Pharmaceutical will unveil at the AACR include LAPSIL-2analog (HM16390), EZH1/2 dual inhibitor (HM97662), SOS1 inhibitor (HM99462), YAP/TAZ-TEAD inhibitor, mRNA anti-cancer vaccine, and PD-L1/4-1BB BsAb (BH3120).
https://www.koreabiomed.com/news/articleView.html?idxno=20823
Spectrum should pay attention if they want to build their own pipeline.

[dcaf7]

Yes, Poziotinib works. But toxicity issues are real. For any company who is thinking buy it, you need to consider a necessary phase 3 trial and competition. I can see a few drugs in clinical trials that can potentially work as Pozi but less toxic. Will be interesting to see Pyrotinib data.

[ATLcitizen]

Hi Dcaf7! Nice to be able to chat with you again! It would be a shame if this is the end of Pozi. Must be a reason why MDA and Spectrum are still running or finishing a few Pozi trials? Maybe they are keeping hope alive? It would probably never be more than a 3rd line or niche drug, but still there is unmet need.

[dcaf7]

Hi, ATLcitizen. Good to see you here. I don't have much hope for Pozi now and will be surprised if they can sell it.

[ATLcitizen]

Greetings! @dcaf7: thanks for pointing out these slides! Not sure how long Michael Grabow has been with Spectrum as CBO, but he's from Amgen too. I hope all this Amgen experience will pay off for R. sales! Seeing the structural comparison of drugs really drives home the point visually that R. is a unique drug, quite different from Neulasta. Their best prospects for sales are Clinic and 340-B hospitals and according to their slide that is 70% of the market, which they are focusing on. Will be interesting to see next month in quarterly earnings report how Q1 went without a permanent J code. We'll have to wait until August to see how permanent J code affects sales for Q2. Wonder what they're planning for Pozi. I figure they're trying to find a buyer and keep most important studies going until then.

[dcaf7]

New corporate presentation posted. Interesting slides:
#3. New person in management team, Erin Miller, Senior Vice President Sales and Marketing. She worked at Amgen.
#6. Shows a difference in molecular structures of Rolvedon and Neulasta. I like it.
#7. Familiar bar graphs demonstrating effects of Rolvedon and Neulasta on incidence and duration of severe neutropenia. All in favor of Rolvedon but no error bars and p values.
#11. Rolvedon launch plan including all incremental steps and time. Who made this slide is a creative person.
Not a word about Poziotinib.
https://investor.sppirx.com/static-files/2977ecaa-f5d9-42e3-91af-ed6738a39993

[dcaf7]

I think, it is Rolvedon.

[hiker4]

Thanks, dcaf7 for the VA news. In clicking threw the links + Spectrum's website I can't tell what
this VA contract is for? Rolvedon? What do you think? Thanks, in advance.

[Femto99]

It is interesting to look back 10 years https://investor.sppirx.com/news-releases/news-release-details/spectrum-pharmaceuticals-licenses-novel-long-acting-gcsf-drug-us

[dcaf7]

Spectrum Pharmaceuticals Has Been Awarded A Five Year Veterans Affairs Federal Supply Schedule Contract Initially Worth $23M
https://www.benzinga.com/general/biotech/23/03/31534829/spectrum-pharmaceuticals-has-been-awarded-a-five-year-veterans-affairs-federal-supply-schedule-co
6505--Spectrum Pharmaceuticals, Inc. Contract Award 4/15/2023 to 4/14/2028 Spectrum Pharmaceuticals
https://sam.gov/opp/b7421fb148904a81970ef3440ec2c235/view

[dcaf7]

My guess, if data is good, they will need to run ph2/3 study for approval. On the other hand, they might choose just to publish data without pursuing approval. In this case physicians can use same day regimen off label.

[Femto99]

Do you think they need P2 to get the same-day dosing approved, or the P1 is enough? Thanks.
https://www.clinicaltrials.gov/ct2/show/NCT04187898?term=SPI-GCF-104&draw=2&rank=1
I tripled my position Friday
Edit: I listened to the CC, seems they expect some follow up trial request from FDA

[dcaf7]

Following the latest results, Spectrum Pharmaceuticals' five analysts are now forecasting revenues of US$50.6m in 2023. The loss per share is expected to greatly reduce in the near future, narrowing 46% to US$0.21.
https://finance.yahoo.com/news/earnings-spectrum-pharmaceuticals-inc-nasdaq-141328127.html

[Femto99]

We will see the profit margin in May. I will take anything above 75%

[dcaf7]

I don't think it was disclosed by Spectrum or Hanmi. I know that gross profit margin for Udenica, a biosimilar of Neulasta, was higher than 90% a few years ago.

[Femto99]

Dcaf, what do you expect the cost margin for ROLVEDON to be? From what I read, ROLVEDON is supplied by Hanmi.

[dcaf7]

Mar. 23, 2023, 10:15 AM
Jefferies analyst Maury Raycroft maintained a Buy rating on Spectrum Pharmaceuticals (SPPI – Research Report) yesterday and set a price target of $3.50. The company’s shares opened today at $0.73.

[dcaf7]

In today's earning call, Tom said that they are going to present data from a same-day Rolvedon trial in 2H23. It is what their R&D department is working on now, besides pediatric study. I was hoping to hear about their future pipeline but nothing was said. Looks like Rolvedon sales in 1Q23 will be OK. J-code will be in force from April 1.

[dcaf7]

Just published, "Poziotinib in Treatment-Naïve Non-Small-Cell Lung Cancer Harboring HER2 Exon 20 Mutations: ZENITH20-4, A Multicenter, Multicohort, Open-label Phase 2 Trial (Cohort 4)" by many authors including Heymach, Lebel and Socinski.
Good article. A lot of positive data but at the end you can find "The ZENITH20 study was terminated due to an FDA decision".
https://www.jto.org/article/S1556-0864(23)00199-5/fulltext

[buc17]

thanks decaf your the man

[dcaf7]

Another Heymach study with poziotinib will be presented at AACR, "Role of individual HER family members and pan-HER targeting treatment strategy in NRG1 fusion positive cancer".
From the abstract.
NRG1 gene fusions are rare, clinically actionable somatic alterations identified in 0.1% of all tumors. Previous studies have demonstrated that NRG1 fusions signal through ERBB/HER family members and that HER2 inhibition has anti-tumor activity in NRG1 fusion-driven cancers. However, NRG1 can also bind to HER4 in addition to HER3, and the contribution of individual HER family members in tumor cells with NRG1 fusions has not been fully elucidated.
Our data indicated that pan-HER tyrosine kinase inhibitors (TKIs), such as poziotinib, were more effective at blocking HER2/HER3, EGFR/HER3 and HER4 signaling in NRG1-fusion expressing cells as compared to TKIs with greater relative specificity for EGFR (erlotinib, lapatinib), HER2 (pyrotinib), EGFR/HER2 (afatinib, dacomitinib, neratinib) or HER2/HER4 (TAS0728,tucatinib).
https://www.abstractsonline.com/pp8/#!/10828/presentation/6748

[dcaf7]

New poziotinib data will be presented at AACR 2023 meeting by Heymach group. Abstract title: "Trastuzumab deruxtecan resistance is associated with reduced responsiveness to topoisomerase inhibitors (payload resistance) but no reduction in sensitivity to HER2 tyrosine kinase inhibitors''. They demonstrated that poziotinib may retain anti-tumor cell activity in HER2 mutant tumor cells with acquired resistance to HER2 ADCs such as Enhertu.
https://www.abstractsonline.com/pp8/#!/10828/presentation/9193

[BarrellofHay]

Because data is showing strong promise for this subgroup

[dcaf7]

Spectrum updated pipeline on corporate website. They removed all cohorts of Zenith-20 trial, except one, Previously treated HER2 exon 20 insertion mutation positive NSCLC. Why didn't they remove this one?

[BarrellofHay]

I am surprised this has not been bought out yet

[dcaf7]

I have a few.

[spiderman3600]

Thanks decaf. Do you still own any shares?

[dcaf7]

Korean analyst on Rolvedon

Published 2023.03.03 18:33

Hanmi Pharm's R&D prowess is also being proven in the U.S. with Rolvedon.

Rolvedon is Hanmi's first new biologic drug that is used to treat or prevent severe neutropenia in cancer patients who have undergone chemotherapy.

The drug is the first product to receive marketing approval by applying Hanmi's proprietary platform technology, "LAPSCOVERY," which boosts a bio-medicine's efficacy.

Hanmi had previously licensed out the treatment to Spectrum Pharmaceuticals, its U.S. partner, in 2012, and Spectrum received approval in September of last year.

Notably, there is additional hype surrounding the success of Rolvedon as it recently got listed on the U.S. public insurance reimbursement drug list.

Industry watchers expect that the listing will have a positive impact on expanding prescriptions and establishing brand awareness as the cost burden of patients is lowered.

Local analysts also expect good performance from Rolvedon this year.

"Spectrum estimation Rolvedon's sales in the fourth quarter of last year was $10 million," said Ha Hyeon-soo, an analyst at Yuanta Securities. "The drug's sales target this year is $100 million as the top three community oncology networks in the U.S. started using Rolvedon, and the three communities account for about 22 percent of the total clinic market."
https://www.koreabiomed.com/news/articleView.html?idxno=20574

[dcaf7]

However, in January, Reuters found an even higher median annual price of $193,900 for 17 novel drugs the FDA has approved since July 2022, paced by the $3.5 million list price of CSL’s Hemgenix®, the first and only FDA-approved gene therapy for hemophilia B and the most expensive drug ever sold (to date).

But Reuters acknowledged the median had fallen from $257,000 in the first half of 2022, thanks to five drugs marketed with five-figure list prices, the lowest being Spectrum Pharmaceuticals’ Rolvedon™, an infection-fighting drug in adults with non-myeloid malignancies, whose price the news agency pegged at $27,000 based on wholesaler information.
https://www.genengnews.com/gen-edge/the-unbearable-cost-of-drug-development-deloitte-report-shows-15-jump-in-rd-to-2-3-billion/

[cuggegrosse]

I believe they need a new CEO... ASAP.NO JOKE !!!! LOOKING FOR DIRECTORS' NAMES,NONE TO BE FOUND..... REVS almost not exsisting ????

[buc17]

thanks decaf

[hiker4]

Well, I really like 100 million this year. These sale numbers are considerably more than their earlier estimates. Good catch dcaf7. Thanks

[dcaf7]

$100M this year, how about that?
US sales of Hanmi Pharmaceutical Co.’s Rolvedon (eflapegrastim-xnst), a drug used to reduce the incidence of infection as manifested by febrile neutropenia in adult patients with non-myeloid malignancies, topped $10 million just three months after its launch in the US by Spectrum Pharmaceuticals Inc. The US partner projected its sales would reach $100 million this year.
https://www.kedglobal.com/bio-pharma/newsView/ked202302270012

[cuggegrosse]

One more thing,how is the law suit proceeding ???

[cuggegrosse]

That's a very good question which I have no answer for,some one else maybe has ????

[dcaf7]

Armistice Capital Now Owns 8.37% of Spectrum Pharmaceuticals (SPPI).
2023-02-14 18:31
Fintel reports that Armistice Capital has filed a 13G/A form with the SEC disclosing ownership of 17.00MM shares of Spectrum Pharmaceuticals, Inc. (SPPI). This represents 8.37% of the company.

In their previous filing dated February 15, 2022 they reported 9.67MM shares and 5.90% of the company, an increase in shares of 75.88% and an increase in total ownership of 2.47% (calculated as current - previous percent ownership).

The projected annual revenue for Spectrum Pharmaceuticals is $46MM, a decrease of 57.97%. The projected annual EPS is -$0.26.
https://fintel.io/news/armistice-capital-now-owns-837-of-spectrum-pharmaceuticals-sppi-858

Wonder, why a decrease of 58%? Were they projecting $100M? Is it about lost Poziotinib revenue?

[buc17]

thanks decaf

[dcaf7]

Preliminary data are not convincing, but they run an expansion phase of the trial with 30 min post TC dosing. Waiting for results. To me, positive outcome would be a surprise.

[buc17]

hi everyone, like the rally were having, just keep the dream alive, hey decaf whats your thoughts on same day injection, could that be our next leg up. thanks for your thoughts, looks like the shorts r trying to keep it below a buck, but we have come along way in a short period of time, i guess we need to go down so we can go back up

[Frankestin]

a permanent J-code, J1449, has been issued for ROLVEDON by the U.S. Centers for Medicare & Medicaid Services (CMS) effective as of April 1, 2023.

“This is an important milestone in the ROLVEDON launch. A permanent J-code will enable a more efficient and predictable reimbursement in the outpatient setting. The combination of a permanent J-code on April 1, 2023 and ROLVEDON’S inclusion in the National Comprehensive Cancer Network® Supportive Care Guidelines (NCCN Guidelines) announced on December 6, 2022 are key elements in establishing brand awareness and building customer confidence in our novel product,” said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals.

J-codes are permanent reimbursement codes used by commercial insurance plans, Medicare, Medicare Advantage, and other government payers for Medicare Part B drugs like ROLVEDON that are administered by a physician. Claims submission and documentation are simplified with a permanent J-code, facilitating and streamlining the billing and reimbursement process.

[dcaf7]

Rolvedon sales estimate from Hanmi.
By Jae-Young Han Feb 02, 2023
Launched in the US last October, the drug is expected to account for 2% of the country's neutropenia treatment market in 2023.
Rolvedon is expected to post about $60 million in revenue in the US market this year, accounting for 2% of neutropenia treatment in the country.
https://www.kedglobal.com/bio-pharma/newsView/ked202302020001

[dcaf7]

Applying conservative P/E of 20 it gives us $4.4/share in 2025 if number of shares is 200 million.

[spiderman3600]

Over 200 million shares outstanding. Growing about 20% per year. Better then nothing!

[dcaf7]

More estimates.
Research analysts at Jefferies Financial Group dropped their FY2025 earnings per share (EPS) estimates for shares of Spectrum Pharmaceuticals in a research note issued to investors on Wednesday, February 1st. Jefferies Financial Group analyst M. Raycroft now expects that the biotechnology company will post earnings per share of $0.22 for the year, down from their prior forecast of $0.23. The consensus estimate for Spectrum Pharmaceuticals’ current full-year earnings is ($0.48) per share. Jefferies Financial Group also issued estimates for Spectrum Pharmaceuticals’ FY2026 earnings at $0.27 EPS and FY2027 earnings at $0.33 EPS.

[hiker4]

Thanks, dcaf7 for your response. I value your views.

[dcaf7]

Part of 10b5-1 trading plan. No concern.

[hiker4]

Thanks dcaf7 for the info and I like the new yearly revenue targets. BTW Are you concerned at all about the recent SPPI insider selling on Jan 30/31, 2023? Thanks

[dcaf7]

H.C. Wainwright analyst Edward White says Spectrum Pharmaceuticals’ Q4 net sales of $10M dramatically beat the firm’s estimate of $3.0M. Rolvedon is a long-acting granulocyte colony stimulating factor intended to stimulate neutrophil production for the treatment of chemotherapy-induced neutropenia patients. The fact that Rolvedon is a novel product with reimbursement not tied to Neulasta and its biosimilars could enable it to gain a substantial market share over time, the analyst tells investors in a research note. The firm now estimates Rolvedon sales of $70.0M in 2023 compared to a prior estimate of $48.0M. It reiterates a Buy rating on the shares with a $4 price target.
$70M, if true, will possibly bring Spectrum close to profitability. Will definitely reduce cash burn substantially.

[Frankestin]

with patience above 1 and beyond!