Puma Biotechnology (NASDAQ: PBYI) raised its full-year 2026 guidance Thursday at the H.C. Wainwright 28th Annual Global Investment Conference, citing continued momentum in its lead drug NERLYNX and progress across its pipeline.
Second-quarter NERLYNX U.S. revenue rose to $53.6 million, up 9% from $49.2 million a year earlier and 27.1% from $42.2 million in Q1, according to company remarks prepared by president and CEO Alan H. Auerbach. Commercial demand reached 2,986 units in Q2, compared with 2,693 units in the year-ago quarter and 2,786 in Q1. Ex-factory bottles sold totaled 2,929 units, versus 2,608 a year earlier.
The company also reported Q2 net income of $8.2 million and cash and cash equivalents of $93.9 million. Quarterly cash burn came in at $9.7 million, primarily driven by debt repayment, leaving the company debt-free. Shares outstanding stand at 51.1 million, with a market capitalization of approximately $470 million and a P/E ratio of 18.
Full-year guidance was lifted across both top and bottom lines. NERLYNX U.S. revenue is now expected to reach $205 million to $209 million, up from prior estimates, while net income is projected at $17 million to $20 million. For Q3, NERLYNX U.S. revenue is guided at $54 million to $56 million, with total revenue expected between $56 million and $59 million.
NERLYNX, the extended-adjuvant treatment for HER2-positive breast cancer, faces patent cliffs on different claims through the early 2030s. Its composition-of-matter patent expires in 2030, polymorph patents in 2028, the combination with capecitabine in 2031, and the extended adjuvant indication in 2030.
Auerbach described NERLYNX as "the first drug that is a HER2-directed drug approved for the extended adjuvant treatment of HER2-positive breast cancer" and noted it remains the only tyrosine kinase inhibitor approved in both early-stage and metastatic settings for the same indication. International distribution continues through partners including Specialized Therapeutics, Medison Pharma, Knight Therapeutics, Pint Pharma, Bixink Therapeutics, Er-Kim, and Pierre Fabre across global territories.
Pipeline developments centered on alisertib, an Aurora kinase A inhibitor advancing through Phase II studies. In the ALISCA-Breast1 trial for ER-positive, HER2-negative metastatic breast cancer, dose-escalation data showed response rates of 5% at 30 mg, 20% at 40 mg, and 18.4% at 50 mg twice daily. Progression-free survival averaged approximately two months at 30 mg and 5.5 months at both the 40 mg and 50 mg doses. Grade 3/4 neutropenia at 50 mg occurred in 26.9%, lower than the historical 41%–42% rate observed in earlier studies.
Biomarker analysis revealed notably longer PFS in patient subgroups: those with high c-MYC copy number (>2) achieved 7.29 months of PFS compared with two months for copy number equal to 2. Patients with ESR1 mutations saw 3.7 months of PFS on the 40 mg arm and 9.3 months on the 50 mg arm, while PIK3CA wild-type patients reached 5.65 months on 40 mg and had not yet reached median PFS on 50 mg.
In the ALISCA-Lung1 study for extensive-stage small cell lung cancer, dose escalation moved from 50 mg to 60 mg and is now enrolling at 70 mg twice daily. At 50 mg, median PFS was 1.68 months with a partial response rate of 11.5%; at 60 mg, median PFS improved to 4.17 months with a partial response rate of 6.7% and Grade 3/4 neutropenia of 11.1% with prophylactic G-CSF support. A new combination trial, ALISCA-Lung2, pairing alisertib with paclitaxel in patients with c-MYC or RB1 mutations is expected to begin enrollment this quarter.
Auerbach said he is "very optimistic" that the 70 mg dose will continue to show favorable activity. Alisertib's composition-of-matter patent expires in 2029, with use patents for proliferative diseases and oncology, small cell lung cancer, and breast cancer extending through 2032 to 2034.
Puma is also studying a combination of neratinib with T-DXd (fam-trastuzumab deruxtecan, marketed as ENHERTU) in an NCI-sponsored Phase I trial for HER2-mutated or HER2 3+ IHC tumors across gastric junction, esophageal, pancreatic, and ovarian cancers. Interim data presented at the AACR meeting showed preclinical and synergistic activity, with further results expected in 2027.
The stock traded at $9.14, near its 52-week high of $9.73, reflecting a 104% return over the past year. The company's last equity issuance was a private placement in December 2022.
