Along with reporting 3Q16 earnings that beat estimates and raising full-year guidance, Bristol-Myers Squibb Co. (NYSE:BMY) on Thursday announced it would keep non-GAAP operating expenses "roughly flat" in 2016-20, even as it increases R&D spending in priority areas.
In 3Q16, adjusted EPS rose to $0.77, up 97% from $0.39 in 3Q15 and beating the $0.65 consensus. Revenues were $4.92 billion, up 21% from $4.07 billion in 3Q15 and topping the $4.79 billion consensus.
The pharma raised its full-year 2016 adjusted EPS guidance for a third time, to $2.80-$2.90 from $2.55-$2.65, above the $2.63 consensus estimate. BMS had raised guidance in its 1Q16 and 2Q16 earnings.
The company also issued its first full-year guidance for 2017. It expects adjusted EPS of $2.85-$3.05 next year; the consensus estimate is $2.91 per share.
BMS shares gained $2.62 to $51.96 on Thursday, adding about $4.5 billion in market cap.
Sales of PD-1 inhibitor Opdivo nivolumab rose to $920 million in 3Q16, up 10% sequentially from $840 million in 2Q16. BMS said it remained optimistic about the PD-1 inhibitor despite setbacks in first-line non-small cell lung cancer (NSCLC), where it missed the primary endpoint in a Phase III study in August.
On Thursday's conference call, management said the pharma's forecast assumes Opdivo will not be used in the second-line setting for NSCLC patients who receive prior treatment with rival PD-1 inhibitor Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK), which FDA approved for the first-line setting on Monday (see BioCentury Extra, Oct. 24).
BMS noted it expected first-line treatments would be confined to patients with 50% or greater expression of PD-L1, as Keytruda's label allows, leaving "quite a large pool" of second-line patients who are eligible for treatment with Opdivo.
"While our second-line lung business will be under some pressure, we believe we have opportunities for growth in renal, melanoma and Hodgkin's as well as future indications such as bladder and head and neck" cancers, said CFO Charles Bancroft.
BMS said the "streamlined operations and realigned manufacturing capabilities" would allow it to reallocate resources to priority areas including immuno-oncology, heart failure, fibrosis, and selected genetically defined diseases.
The pharma also announced a $3 billion share buyback. An ongoing $3 billion buyback, announced in 2012, has $1.1 billion remaining.
Allergan plc (NYSE:AGN) exercised its option to acquire the Motus Therapeutics Inc. subsidiary of Rhythm Holding Co. LLC (Boston, Mass.) for $200 million. It plans to begin Phase III trials of Motus' lead candidate relamorelin (RM-131) to treat gastroparesis in patients with Type I and Type II diabetes.
Also on Thursday, the companies announced top-line data from a Phase IIb trial of relamorelin showing that the ghrelin agonist reduced vomiting frequency, the primary endpoint, by about 75% compared to baseline. However, an unusually high placebo response "limited the ability to demonstrate treatment efficacy" on the endpoint. The companies did not respond to inquiries.
Allergan and Rhythm also said the Phase IIb data showed "substantial efficacy" for the gastroparesis symptoms of nausea, post-prandial fullness, abdominal pain and bloating as well as a prokinetic effect on gastric motility. The companies plan to submit the data for presentation at a medical conference next year.
Rhythm is eligible for an undisclosed payment upon first commercial sale of relamorelin.
Allergan previously paid Rhythm $47 million, including $40 million up front, under the 2014 option deal. The acquisition is slated to close by YE16 (see BioCentury Extra, Oct. 30, 2014).
Aerie Pharmaceuticals Inc. (NASDAQ:AERI) said it withdrew its NDA for Rhopressa netarsudil ophthalmic solution 0.02% to treat intraocular pressure in glaucoma and ocular hypertension patients. It had submitted the application to FDA last month.
Aerie said a third-party manufacturing facility was not prepared for pre-approval inspection. The company expects the issue to be resolved in January 2017, when it plans to re-submit the NDA.
Aerie also said Rhopressa met the primary endpoint of the Phase III Rocket 4 study by showing non-inferiority to twice-daily timolol. The company said the study is not needed for the NDA, but it plans to include the trial's six-month safety data in an eventual submission of an MAA to EMA for the dual inhibitor of Rho kinase and the norepinephrine transporter. Aerie expects to complete Rocket 4 in 2Q17.
Aerie, which announced the news after market close, fell $0.84 to $33.28 on Thursday.
AstraZeneca plc (LSE:AZN; NYSE:AZN) said FDA placed a partial clinical hold on trials of its PD-L1 inhibitor durvalumab (MEDI4736) as monotherapy or in combination with tremelimumab (CP-675) to treat squamous cell carcinoma of the head and neck (SCCHN). The hold follows the pharma's decision to pause enrollment in the Phase III KESTREL and EAGLE trials to analyze reported bleeding events.
AstraZeneca said existing patients will continue in the trials.
The hold covers only trials related to SCCHN. AZ still expects data in 1H17 from the Phase III MYSTIC study of durvalumab, alone or in combination with tremelimumab, as a first-line therapy for non-small cell lung cancer (NSCLC).
Durvalumab is a human IgG1 mAb targeting PD-L1, while tremelimumab targets cytotoxic T-lymphocyte associated protein 4 (CTLA4; CD152).
AstraZeneca slipped 162.50p to 4,614.50p in London on Thursday, and lost $1.05 to $28.54 in New York.
Drug distribution company China Resources Pharmaceutical Group Ltd. (HKSE:3320) raised HK$14 billion ($1.8 billion) through the sale of 1.5 billion shares at HK$9.10 in an IPO underwritten by BofA Merrill Lynch, CCB International Capital, China International Capital Corp., Goldman Sachs, Morgan Stanley, China Merchants Securities, ICBC International Securities Ltd., HSBC, Mizuho, China Securities International, BOC International, CMB International Capital, ABC International and JPMorgan. The price valued the company at HK$56.2 billion ($7.2 billion).
Investors included Hengjian International Investment Holding Ltd., China Life Insurance Co. Ltd. and Fujifilm Holdings Corp. (Tokyo:4901).
The company's portfolio includes Chinese medicines, biopharmaceuticals, nutritional and health products. The company, which said it is the second largest pharmaceutical distribution business in China, reported 2015 revenue of HK$146.6 billion ($18.9 billion).
Endocrine disorder company Myovant Sciences Ltd. (NYSE:MYOV) lost $1.74 (12%) to $13.26 in its first day of trading Thursday after raising $217.5 million through the sale of 14.5 million shares at $15 in an IPO underwritten by Citigroup, Cowen, Evercore, Barclays, JMP Securities and Baird. The price valued Myovant at $903.4 million.
Pfizer Inc. (NYSE:PFE) and BB Biotech AG (Xetra:BBZA) purchased a combined $30 million of Myovant stock in the offering. Concurrently, Myovant granted Pfizer a right of first negotiation in potential deals for either of Myovant's two lead candidates, relugolix (TAK-385) or RVT-602, to treat uterine fibroid-associated heavy menstrual bleeding, endometriosis-associated pain, advanced prostate cancer or female infertility. Pfizer also has rights of first negotiation for the sale of Myovant itself.
Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) and Roivant Sciences Ltd. (Hamilton, Bermuda) launched Myovant in June and granted the company exclusive ex-Asian rights to relugolix and RVT-602 (see BioCentury Extra, June 7).
Myovant plans to begin Phase III testing of relugolix in uterine-fibroid associated heavy menstrual bleeding, endometriosis-associated pain and advanced prostate cancer, beginning in 1Q17. The candidate is a luteinizing hormone-releasing hormone (LHRH) receptor antagonist. RVT-602 is an oligopeptide kisspeptin receptor agonist.
Unity Biotechnology Inc. (San Francisco, Calif.) raised $116 million in a series B round led by Arch Venture Partners and Baillie Gifford. New investors Fidelity, Partner Fund Management, Bezos Expeditions and existing investors Venrock, the WuXi PharmaTech Inc. subsidiary of New WuXi Life Science Ltd. (Shanghai, China), and Mayo Clinic also participated. According to BioCentury's BCIQ database, the financing is the 12th largest series B round since BioCentury started tracking financings in 1994.
Unity is developing small molecule therapies that selectively induce death of senescent cells to treat age-related diseases. President Nathaniel David declined to disclose the compounds' targets.
Unity expects to begin Phase I testing within 18 months of its unnamed lead candidate to treat osteoarthritis (OA) of the knee. It plans to identify a second candidate this year for ophthalmology indications including glaucoma and age-related macular degeneration (AMD).
CEO Keith Leonard expects the funding will allow Unity to obtain clinical proof of concept in two indications and begin clinical testing in a third by early 2019. The funding will also support identification of new targets and compounds against senescent cells.
Also on Thursday, two Unity scientific co-founders reported preclinical data in Science implicating senescent cells as drivers of atherogenesis and disease progression in transgenic mouse models of atherosclerosis. Furthermore, the study showed that selective elimination of senescent cells in mouse models stabilized atherosclerotic plaque, inhibited plaque growth and reduced inflammation.
Bioceramics company BoneSupport AB (Lund, Sweden) raised $37 million in equity and debt. Spokesperson David Dible declined to give details, but said a "significant majority" of the funding was equity.
Tellacq AB led the oversubscribed equity component, while HealthCap, Lundbeckfond Ventures, Industrifonden, AP3 and Carl Westin also participated. Kreos Capital provided the debt.
Using its Cerament platform, BoneSupport develops injectable drug eluting products to treat bone voids.
Celgene Corp. (NASDAQ:CELG), Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) and Amgen Inc. (NASDAQ:AMGN) reported earnings Thursday.
Celgene beat 3Q16 estimates and raised full-year 2016 guidance for both adjusted EPS and revenues. The company now expects adjusted EPS of $5.88-$5.92 on revenues of $11.2 billion for the year, up from the previous estimates of $5.70-$5.75 and $11 billion. Sales of multiple myeloma drug Revlimid lenalidomide were nearly $1.9 billion for the quarter, up 30% from 3Q15. The company now expects $7 billion in Revlimid sales this year. Adjusted 3Q16 EPS was $1.58 on total revenues of $2.98 billion, beating the consensus of $1.48 per share on $2.83 billion in revenues.
Celgene shares rose $6.34 to $104.75 on Thursday, ending with a market cap of $81.2 billion.
Alexion said sales of hypophosphatasia drug Strensiq asfotase alfa reached $60.5 million in 3Q16, up 34% sequentially from $45.1 million in 2Q16. The company launched Strensiq in October 2015. Total revenues were $799.1 million, up 20% from $666.6 million in 3Q15 largely on the strength of continued sales growth for complement 5 (C5) inhibitor Soliris eculizumab, which accounted for 91% of total 3Q16 revenues. Alexion also said it began two Phase III trials of long-acting C5 inhibitor ALXN1210 to treat paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), the two approved indications for Soliris.
Alexion rose $9.78 to $131.37 on Thursday to close with a market cap of $29.5 billion.
Amgen's adjusted EPS of $3.02 and total revenues of $5.81 billion both beat consensus estimates of $2.79 per share on $5.73 billion in revenues. The company boosted full-year EPS guidance to $11.40-$11.55 from $11.10-$11.40.
Worldwide sales of PCSK9 inhibitor Repatha evolocumab were $40 million, up sequentially from $27 million in 2Q16.
Total product sales were flat in 3Q16 compared to 3Q15.
Amgen reported the news after market close.
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