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Operator
Operator
Greetings, and welcome to the Ligand Pharmaceuticals quarterly earnings conference call.
您好,歡迎參加配體製藥公司季度收益電話會議。
(Operator Instructions) As a reminder, this conference is being recorded.
(操作員指示)謹此提醒,本次會議正在錄製中。
I would now like to turn the conference over to your host, Todd Pettingill.
現在我想將會議交給主持人托德·佩廷吉爾。
Thank you.
謝謝。
Please, begin.
請開始。
Todd Pettingill
Todd Pettingill
Welcome to Ligand's First Quarter of 2017 Financial Results and Business Update Conference Call.
歡迎參加 Ligand 2017 年第一季度財務業績和業務更新電話會議。
Speaking today for Ligand are John Higgins, CEO; Matt Foehr, President and COO; and Matt Korenberg, CFO.
今天為 Ligand 發言的是首席執行官約翰·希金斯 (John Higgins); Matt Foehr,總裁兼首席運營官;和首席財務官馬特·科倫伯格。
As a reminder, today's call will contain forward-looking statements within the meaning of federal securities laws.
提醒一下,今天的電話會議將包含聯邦證券法含義內的前瞻性陳述。
These may include, but are not limited to, statements regarding intent, belief or current expeditions of the company and its management regarding its internal and partner programs.
這些可能包括但不限於有關公司及其管理層關於其內部和合作夥伴計劃的意圖、信念或當前考察的聲明。
These statements involve risks and uncertainties and actual events or results may differ materially from the projections described in today's press release in this conference call.
這些陳述涉及風險和不確定性,實際事件或結果可能與今天的電話會議新聞稿中描述的預測存在重大差異。
Additional information concerning risk factors and other matters concerning Ligand can be found in Ligand's earnings press release and public periodic filings with the Securities and Exchange Commission, which are available at www.sec.gov.
有關 Ligand 的風險因素和其他事項的更多信息,請參閱 Ligand 的收益新聞稿以及向美國證券交易委員會提交的公開定期文件,這些文件可在 www.sec.gov 上獲取。
Information on this conference call related to projections or other forward-looking statements represent the company's best judgment based on information available and reviewed by the company as of today, May 9, 2017, and do not necessarily represent the views of any other party.
本次電話會議中涉及預測或其他前瞻性陳述的信息代表公司根據截至今天(2017 年 5 月 9 日)可獲得併經公司審核的信息做出的最佳判斷,並不一定代表任何其他方的觀點。
Ligand undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of the conference call.
Ligand 不承擔修改或更新任何聲明以反映電話會議日期之後的事件或情況的義務。
At this time, I'll turn the call over to John Higgins.
此時,我會將電話轉給約翰·希金斯。
John L. Higgins - CEO & Executive Director
John L. Higgins - CEO & Executive Director
Good afternoon, and thanks for joining the call.
下午好,感謝您加入通話。
The first quarter of 2017 was a very solid quarter, financially, coming in line with our expectations and setting us on a path to achieve our core revenue outlook of at least $130 million for the year.
2017 年第一季度的財務狀況非常穩健,符合我們的預期,並為我們實現全年至少 1.3 億美元的核心收入前景奠定了基礎。
We signed a few important new licensing deals during the quarter; and the OmniAb business, our antibiotic discovery technology, continues to perform very well.
我們在本季度簽署了一些重要的新許可協議;我們的抗生素發現技術 OmniAb 業務繼續表現出色。
Now of note, royalty revenue was especially strong, coming in just over $24 million for the quarter.
值得注意的是,特許權使用費收入尤其強勁,本季度收入略高於 2400 萬美元。
That's an increase of close to 70% over Q1 2016.
比 2016 年第一季度增長了近 70%。
Captisol sales were just over $1 million, as we expected, given the timing of annual orders.
考慮到年度訂單的時間安排,Captisol 銷售額剛剛超過 100 萬美元,正如我們預期的那樣。
It's worth noting, as a reminder, that Captisol sales were $9.1 million in the fourth quarter last year, which was one of the highest quarterly revenues from the material since we acquired it 6 years ago.
值得注意的是,去年第四季度 Captisol 的銷售額為 910 萬美元,這是自我們 6 年前收購該材料以來最高的季度收入之一。
The large Q4 followed by lower Q1 is a pattern we've seen in the last few years.
第四季度較大,第一季度較小,這是我們在過去幾年中看到的模式。
And licensing and milestone payments came in at about $4 million, a strong quarter for contract revenue but lower than the comparison period last year due to the significant $6 million payment we received as a result of the EVOMELA approval milestone in Q1 2016.
許可和里程碑付款約為 400 萬美元,對於合同收入來說是一個強勁的季度,但低於去年同期,因為我們在 2016 年第一季度獲得 EVOMELA 里程碑批准後收到了 600 萬美元的巨額付款。
Now that EVOMELA is on the market, we are booking revenue, both in the royalty line as well as revenue in the Captisol material sales line.
現在 EVOMELA 已上市,我們正在預訂收入,包括特許權使用費收入和 Captisol 材料銷售收入。
Ligand opened the year strong, and both our financial and operating performance reinforces that.
Ligand 開局強勁,我們的財務和運營業績也強化了這一點。
Financially, we continue to show very high efficiency in our income statement.
在財務方面,我們的損益表繼續顯示出非常高的效率。
In addition to exceptional growth in royalties, which represents our main revenue category, we had 99% corporate gross margins this quarter.
除了代表我們主要收入類別的特許權使用費的顯著增長之外,本季度我們的企業毛利率達到 99%。
It's high, given the revenue mix and that licensing revenue is essentially a 100% gross margin.
考慮到收入結構以及許可收入基本上是 100% 的毛利率,這個數字很高。
And we continue to operate with lean cash operating expenses, permitting the company to enjoy strong EBITDA margins.
我們繼續以精簡的現金運營支出運營,使公司能夠享受強勁的 EBITDA 利潤率。
Now we recently relocated the company to offices that are significantly less expensive and we continue to leverage our laboratory in Kansas, which has a much lower cost of operations.
現在,我們最近將公司搬遷到了成本低得多的辦公室,並且我們繼續利用我們在堪薩斯州的實驗室,那裡的運營成本要低得多。
These are examples of some of our efforts to keep cost low and operate with lean overhead.
這些是我們為保持低成本和精簡管理費用而做出的一些努力的例子。
As for taxes, notably, we are paying about 1% in actual cash taxes, and we'll continue to do so for the next 2 years as our rapidly growing pretax profits work through our accumulated tax assets.
值得注意的是,在稅收方面,我們實際繳納的現金稅約為 1%,並且我們將在未來 2 年繼續這樣做,因為我們快速增長的稅前利潤通過我們積累的稅收資產發揮作用。
All in, the company continues to demonstrate tremendous financial efficiency and leverage, a message we have been talking about for years now.
總而言之,該公司繼續展現出巨大的財務效率和槓桿作用,這是我們多年來一直在談論的信息。
Now on to some product-specific commentary.
現在我們來談談一些特定於產品的評論。
Promacta revenue for Q1, as reported by Novartis, came in at $175 million.
據諾華報告,Promacta 第一季度收入為 1.75 億美元。
That's up significantly from $131 million in Q1 2016.
這比 2016 年第一季度的 1.31 億美元大幅增長。
The comparison to Q4 2016 is flat to down a little, a pattern we have seen in the last few years.
與 2016 年第四季度相比持平甚至略有下降,這是我們在過去幾年中看到的模式。
Novartis cited currency fluctuation negatively impacting their Q1 revenue by a few percent.
諾華公司表示,貨幣波動對其第一季度收入產生了幾個百分點的負面影響。
The outlook for the product is strong and the second and third quarters have shown to be big quarters for growth in the past few years.
該產品的前景強勁,第二和第三季度已被證明是過去幾年增長的重要季度。
Of note, now 13 analysts that cover Novartis provide revenue details for Promacta.
值得注意的是,目前諾華的 13 名分析師提供了 Promacta 的收入詳細信息。
That's more than double the number of analysts that modeled the product 2 years ago.
這比兩年前對該產品進行建模的分析師數量增加了一倍多。
And the peak revenue and consensus revenue expectations for the product have moved up the past few months.
過去幾個月,該產品的峰值收入和共識收入預期有所上升。
The consensus revenue expectations for the product in 2020 is now about $1.1 billion.
目前該產品 2020 年的共識收入預期約為 11 億美元。
Another product we earn royalties on is Amgen's Kyprolis.
我們賺取專利費的另一種產品是安進公司的 Kyprolis。
Kyprolis continues to perform well commercially, and it's an important second-line treatment option for multiple myeloma patients.
Kyprolis 繼續在商業上表現良好,是多發性骨髓瘤患者重要的二線治療選擇。
We have a license agreement with Amgen but are not involved in the commercialization or development of the drug.
我們與安進簽訂了許可協議,但不參與該藥物的商業化或開發。
Amgen reported $190 million in Q1 Kyprolis sales.
安進公佈第一季度 Kyprolis 銷售額為 1.9 億美元。
That's in line with our expectations, and it's up significantly over Q1 2016 sales of $154 million.
這符合我們的預期,並且比 2016 年第一季度 1.54 億美元的銷售額大幅增長。
We also earn royalties on ONO's sales for Kyprolis in Japan, and ONO reports their results on May 11.
我們還從 ONO 在日本銷售 Kyprolis 中賺取特許權使用費,ONO 將於 5 月 11 日報告其業績。
The multiple myeloma market that Kyprolis serves continues to grow and also has become much more competitive over the recent quarters.
Kyprolis 服務的多發性骨髓瘤市場持續增長,並且最近幾個季度的競爭也變得更加激烈。
Nonetheless, Kyprolis remains an important therapy in the category and Amgen executives had several meaningful remarks on their Q1 earnings call last month.
儘管如此,Kyprolis 仍然是該類別中的一種重要療法,安進高管在上個月的第一季度財報電話會議上發表了一些有意義的言論。
Notably, they remarked about major clinical work with Kyprolis, and I quote, "ENDEAVOR was the first head-to-head study to demonstrate a survival benefit versus a current standard-of-cure regimen in this setting, and we are preparing to submit these results to the regulators." And they also said, "The overall survival data for Kyprolis achieved at an interim analysis in relapsed multiple myeloma patients are also very important and timely.
值得注意的是,他們談到了 Kyprolis 的主要臨床工作,我引用道,“ENDEAVOR 是第一項頭對頭研究,證明了在這種情況下與當前標準治療方案相比具有生存益處,我們正準備提交將這些結果提交給監管機構。”他們還表示,“在復發性多發性骨髓瘤患者的中期分析中獲得的 Kyprolis 總體生存數據也非常重要和及時。
Having established superiority versus Velcade, we expect these data will drive increased share for Kyprolis, particularly in the second line, and will also be helpful for reimbursement considerations."
在確立了相對於 Velcade 的優勢後,我們預計這些數據將推動 Kyprolis 的份額增加,特別是在二線領域,並且也將有助於報銷考慮。”
Another product we book royalties from is EVOMELA.
我們收取版稅的另一個產品是 EVOMELA。
And it's a significant royalty rate of 20%, which is the highest rate of all of our royalty-bearing products.
其特許權使用費高達 20%,是我們所有含特許權使用費產品中最高的。
The product was approved in Q1 2016, and as I mentioned earlier, that yielded a significant one-time approval milestone payment.
該產品於 2016 年第一季度獲得批准,正如我之前提到的,這產生了一筆可觀的一次性批准里程碑付款。
Spectrum is the marketing partner, and they announced Q1 products sales for EVOMELA of $6.3 million.
Spectrum 是營銷合作夥伴,他們宣布 EVOMELA 第一季度產品銷售額為 630 萬美元。
This is generally in line with our expectations.
這總體上符合我們的預期。
As we discussed at our Analyst Day in February, Ligand provided its revenue outlook for EVOMELA to be about $25 million for 2017, drawing from third-party analysts that cover the product.
正如我們在 2 月份的分析師日上討論的那樣,Ligand 根據涵蓋該產品的第三方分析師的說法,提供了 EVOMELA 2017 年約 2500 萬美元的收入前景。
Of note, Spectrum said that about $2 million to $3 million of revenue in Q4 related to product stocking at a few hospitals where procedures are performed that use EVOMELA.
值得注意的是,Spectrum 表示,第四季度約 200 萬至 300 萬美元的收入與一些使用 EVOMELA 進行手術的醫院的產品庫存有關。
It's encouraging to see that sort of confidence by hospital users and to know that this important product formulated with Captisol is having such a major impact on the melphalan drug category this early into its life cycle.
令人鼓舞的是,看到醫院用戶的這種信心,並知道這種用 Captisol 配製的重要產品正在馬法蘭藥物類別的生命週期早期對其產生如此重大的影響。
A quick comment about our Licensing activities.
關於我們的許可活動的快速評論。
In Q1, we signed 4 new contracts with partners, further expanding the number of products and territories from which we'll earn potential royalties.
第一季度,我們與合作夥伴簽署了 4 份新合同,進一步擴大了我們賺取潛在特許權使用費的產品和地區的數量。
OmniAb is now on its second year under Ligand's umbrella, and we are very pleased with that business.
OmniAb 現在是 Ligand 旗下的第二個年頭,我們對此業務感到非常滿意。
This past quarter, we signed an important new deal with bluebird bio for CAR T-related products that might utilize OmniAb antibodies.
上個季度,我們與 bluebird bio 簽署了一項重要的新協議,涉及可能利用 OmniAb 抗體的 CAR T 相關產品。
We received a $1 million milestone from Janssen for an IND submission, evidence of more antibodies from this platform advancing and moving into human testing.
我們從楊森獲得了 100 萬美元的里程碑,用於提交 IND,這證明該平台有更多抗體正在推進並進入人體測試。
And we are seeing partners present data on new programs that were discovered with our OmniAb platform.
我們看到合作夥伴提供了通過我們的 OmniAb 平台發現的新項目的數據。
Now with that, I'll turn the call over to Matt Foehr to provide more for portfolio updates.
現在,我將把電話轉給 Matt Foehr,以提供更多有關投資組合更新的信息。
Matthew W. Foehr - President & COO
Matthew W. Foehr - President & COO
Thanks, John.
謝謝,約翰。
I'll start today by reviewing recent developments for some of our partner programs, and I'll also provide updates on our Captisol and OmniAb platforms and related licensing activities.
今天我將首先回顧我們一些合作夥伴計劃的最新進展,我還將提供有關我們的 Captisol 和 OmniAb 平台以及相關許可活動的最新信息。
And I'll discuss our Phase II clinical trial for our glucagon receptor antagonist or GRA diabetes program.
我將討論我們的胰高血糖素受體拮抗劑或 GRA 糖尿病項目的 II 期臨床試驗。
We're continuing to see late-stage positive progression by a growing number of our partners.
我們繼續看到越來越多的合作夥伴在後期取得積極進展。
Our partners at Melinta Therapeutics presented data from the Baxdela clinical program at the European Congress of Clinical Microbiology and Infectious Diseases or ECCMID conference in late April.
我們 Melinta Therapeutics 的合作夥伴在 4 月下旬的歐洲臨床微生物學和傳染病大會或 ECCMID 會議上展示了 Baxdela 臨床項目的數據。
Baxdela has completed Phase III testing and it is the subject of a new drug application that is currently under review at the FDA for the treatment of patients with serious hospital-treated skin infections.
Baxdela 已完成 III 期測試,它是一項新藥申請的主題,目前 FDA 正在審查該藥物用於治療嚴重醫院治療皮膚感染的患者。
The presentations at ECCMID included data from the Phase III program and demonstrated that Baxdela is comparable to vancomycin as treatment in combo therapy in the treatment of patients with acute bacterial skin and skin structure infections.
ECCMID 上的演示包括來自 III 期項目的數據,並證明 Baxdela 在治療急性細菌性皮膚和皮膚結構感染患者的聯合治療中與萬古黴素相當。
Importantly, this was demonstrated not only in the global study population but in 3 key subgroups: patients with diabetes, patients with renal impairment and obese patients.
重要的是,這一點不僅在全球研究人群中得到證實,而且在 3 個關鍵亞組中得到證實:糖尿病患者、腎功能不全患者和肥胖患者。
The action date for the Baxdela NDA is June 19, so about 5 weeks from now.
Baxdela NDA 的行動日期為 6 月 19 日,即距現在大約 5 週。
If approved, Ligand will earn a $1.5 million payment, given Captisol's use in the IV form of the drug.
如果獲得批准,鑑於 Captisol 在該藥物的 IV 形式中的使用,Ligand 將獲得 150 萬美元的付款。
Melinta also recently announced the execution of a license agreement with the Menarini Group for exclusive rights to commercialize Baxdela in 68 countries in the EU, Asia-Pacific and other ex U.S. regions.
Melinta 最近還宣布與美納里尼集團 (Menarini Group) 簽署許可協議,獲得 Baxdela 在歐盟、亞太地區和美國以外其他地區 68 個國家商業化的獨家權利。
Menarini is a global, leading pharmaceutical company, with over 16,000 employees worldwide and with a presence in more than 100 countries, including a direct presence in more than 70 countries.
美納里尼 (Menarini) 是一家全球領先的製藥公司,在全球擁有 16,000 多名員工,在 100 多個國家/地區開展業務,其中直接業務遍及 70 多個國家/地區。
As a general reminder, Ligand has a 2.5% royalty on global net sales of Baxdela IV.
總而言之,Ligand 收取 Baxdela IV 全球淨銷售額 2.5% 的特許權使用費。
Additionally, our partners at Eli Lilly indicated on their recent Q1 earnings call that they continue to be excited about Prexasertib, which is a small molecule inhibitor of checkpoint kinase 1 or CHK1 and, to a lesser extent, CHK2.
此外,禮來公司的合作夥伴在最近的第一季度財報電話會議上表示,他們仍然對 Prexasertib 感到興奮,Prexasertib 是一種檢查點激酶 1 或 CHK1 以及較小程度的 CHK2 的小分子抑製劑。
Prexasertib utilizes our Captisol technology in its formulation.
Prexasertib 在其配方中採用了我們的 Captisol 技術。
Just for some foundational background, CHK1 is a global regulator of the cell cycle, and in addition to the regulating DNA damage checkpoints, CHK1 plays essential role in the normal DNA replication, resolving replication stress, progression to mitosis and cytokinesis.
就一些基礎背景而言,CHK1 是細胞週期的全局調節因子,除了調節 DNA 損傷檢查點外,CHK1 在正常 DNA 複製、解決複製應激、有絲分裂和胞質分裂的進展中也發揮著重要作用。
Inhibition of CHK1, in the absence of DNA damage, can cause impaired DNA replication, loss of DNA damage checkpoints, premature entry into mitosis with highly fragmented DNA in cell death in what's called replication catastrophe.
在沒有 DNA 損傷的情況下,抑制 CHK1 會導致 DNA 複製受損、DNA 損傷檢查點丟失、過早進入有絲分裂、細胞死亡時 DNA 高度碎片化,即所謂的複制災難。
Prexasertib is being investigated by Lilly in Phase II clinical trials in patients with head and neck cancer as well as small cell lung cancer.
禮來公司正在頭頸癌以及小細胞肺癌患者的 II 期臨床試驗中研究 Prexasertib。
And Lilly indicated on their recent earnings call that we should see more data on Prexasertib over the coming next few months, along with updates from them on future development plans.
禮來公司在最近的財報電話會議上表示,我們應該在未來幾個月看到更多關於 Prexasertib 的數據,以及他們關於未來開發計劃的更新。
Switching now to Sparsentan.
現在切換到 Sparsentan。
Our partners at Retrophin met with FDA in the first quarter and received agreement on a path to approval with a single Phase III trial that is to include an internal readout.
我們 Retropin 的合作夥伴在第一季度與 FDA 進行了會面,並就一項 III 期試驗的批准途徑達成了一致,該試驗將包括內部讀數。
Retrophin have indicated that they expect to finalize the Phase III protocol with the FDA in the second half of this year and start the Phase III near the end of the year.
Retropin表示,他們預計將在今年下半年與FDA敲定III期臨床試驗方案,並於年底啟動III期臨床試驗。
Additionally, Retrophin has indicated that they are working with the European regulatory authorities to position the Phase III trial for European registration as well.
此外,Retropin 表示他們正在與歐洲監管機構合作,為歐洲註冊進行 III 期試驗。
We look forward to further update from this high-profile program and also look forward to more dialogue around the asset at upcoming renal scientific meetings.
我們期待這一備受矚目的計劃的進一步更新,也期待在即將召開的腎臟科學會議上圍繞該資產進行更多對話。
Our partners at Aldeyra Therapeutics recently announced the start of a Phase III clinical trial of Captisol-enabled topical ocular ADX-102 for the treatment of non-infectious anterior uveitis or NAU.
我們的 Aldeyra Therapeutics 合作夥伴最近宣布啟動 Captisol 局部眼部 ADX-102 的 III 期臨床試驗,用於治療非感染性前葡萄膜炎或 NAU。
They started the trial following positive results from a Phase II trial that was announced last year.
去年宣布的二期試驗取得積極結果後,他們開始了試驗。
ADX-102 is a novel aldehyde trap and is being developed for a rare and potentially blinding ocular disorder that affects approximately 150,000 patients in the U.S. In contrast to corticosteroids, which are often used to treat NAU, ADX-102 does not appear to cause increases in intraocular pressure, which is a precursor to glaucoma.
ADX-102 是一種新型醛捕捉劑,正在開髮用於治療一種罕見且可能致盲的眼部疾病,該疾病影響著美國約 150,000 名患者。與通常用於治療 NAU 的皮質類固醇相比,ADX-102 似乎不會導致增加眼內壓升高,這是青光眼的先兆。
And according to our partners and Aldeyra, ADX-102 may represent a safer therapeutic option than the current standard of care.
根據我們的合作夥伴和 Aldeyra 的說法,ADX-102 可能是比當前護理標準更安全的治療選擇。
The Phase III clinical trial that was recently started is expected to enroll up to 100 NAU patients with active disease, randomized equally to receive either a topical ocular ADX-102 or vehicle for 4 weeks.
最近開始的 III 期臨床試驗預計將招募多達 100 名患有活動性疾病的 NAU 患者,隨機隨機接受局部眼部 ADX-102 或載體治療,為期 4 週。
Consistent with the successful Phase II trial, the primary endpoint will be the resolution of inflammation.
與成功的 II 期試驗一致,主要終點將是炎症的消退。
Results from that Phase III trial are expected in the second half of 2018.
該 III 期試驗的結果預計將於 2018 年下半年公佈。
As announced previously, in the first quarter, Vertex announced that it licensed rights to Captisol-enabled VX-970 to Merck KGaA, also known as EMD Serono.
正如之前所宣布的,Vertex 在第一季度宣布將支持 Captisol 的 VX-970 的權利授權給 Merck KGaA(也稱為 EMD Serono)。
Now that the program has been brought into the clinical pipeline at Merck KGaA, it has been renamed as M66207, and we look forward to future progression and to discussing the program at next month's ASCO meeting.
現在該項目已進入默克公司的臨床管道,已更名為 M66207,我們期待未來的進展並在下個月的 ASCO 會議上討論該項目。
Switching now to Licensing.
現在切換到許可。
Both our Captisol and OmniAb technologies continue to bring significant value to partners and are facilitating growth and progression of our partner pipeline.
我們的 Captisol 和 OmniAb 技術繼續為合作夥伴帶來巨大價值,並促進我們合作夥伴管道的增長和進步。
We continue to be pleased with the progression of the OmniAb technology and with the feedback we get relating to the technology from current and prospective partners.
我們仍然對 OmniAb 技術的進展以及我們從當前和潛在合作夥伴那裡獲得的與該技術相關的反饋感到滿意。
Our OmniAb team is coming off at very successful Protein Engineering Summit or PEGS conference last week in Boston, which is one of the premier annual globally attended event in the antibody discovery space.
我們的 OmniAb 團隊上週在波士頓參加了非常成功的蛋白質工程峰會或 PEGS 會議,這是抗體發現領域全球最重要的年度活動之一。
Dr. Christel Iffland of Ligand presented the technical details and benefits of the OmniAb platform to a full room of over 130 PEGS attendees during an oral session at the meeting.
Ligand 的 Christel Iffland 博士在會議的口頭會議上向滿場的 130 多名 PEGS 與會者介紹了 OmniAb 平台的技術細節和優勢。
Our existing OmniAb partners are showing significant intangible progression of OmniAb antibodies.
我們現有的 OmniAb 合作夥伴正在展示 OmniAb 抗體的顯著無形進展。
One of the latest example of this is the Janssen J&J, who filed an IND for an OmniAb antibody in Q1 that resulted in a $1 million milestone payment to Ligand.
最新的例子之一是 Janssen J&J,該公司在第一季度提交了 OmniAb 抗體的 IND 申請,最終向 Ligand 支付了 100 萬美元的里程碑付款。
At PEGS last week, our partners at Aptevo, who formed via a spinoff from Emergent Biosciences, (sic) [Emergent BioSolutions] presented positive preclinical data for their OmniMouse-derived anti-CD123 antibody, showing strong in vitro efficacy and picomole arranges and favorable manufacturability properties when formatted as a bi-specific antibody along with and anti-CD3 for key cell engagement.
上週在 PEGS 上,我們的 Aptevo 合作夥伴(由 Emergent Biosciences 分拆而成)[Emergent BioSolutions] 展示了其 OmniMouse 衍生的抗 CD123 抗體的積極臨床前數據,顯示出強大的體外功效和皮摩爾排列,並且有利當與關鍵細胞結合的抗 CD3 一起形成雙特異性抗體時,具有可製造性。
Aptevo refers to the drug as APVO436, and we look forward to watching the progression of this new OmniAb preclinical program.
Aptevo 將該藥物稱為 APVO436,我們期待觀察這一新的 OmniAb 臨床前項目的進展。
We also recently completed a worldwide OmniAb platform license agreement with bluebird bio.
我們最近還與藍鳥生物簽署了全球 OmniAb 平台許可協議。
Under the terms of the deal, bluebird will be able to use the OmniRat, OmniMouse and OmniFlic platforms to discover fully human mono- and bispecific antibodies as well as antibody fragments targeted to the CAR field.
根據協議條款,bluebird 將能夠使用 OmniRat、OmniMouse 和 OmniFlic 平台來發現全人類單特異性和雙特異性抗體以及針對 CAR 領域的抗體片段。
For Captisol.
對於Captisol。
In Q1, we entered into new Captisol license agreement with Eisai, and we expanded our clinical-stage relationship with Marinus for Captisol-enabled IV ganaxolone to a full commercialization and supply relationship.
第一季度,我們與衛材 (Eisai) 簽訂了新的 Captisol 許可協議,並將與 Marinus 的 Captisol 靜脈注射加奈索酮的臨床階段關係擴大到全面的商業化和供應關係。
Merck also added an additional novel compound to their Captisol platform license agreement with us in Q1.
默克還在第一季度與我們簽訂的 Captisol 平台許可協議中添加了一種額外的新型化合物。
And I'll conclude with a brief remark about our internal pipelines, specifically our glucagon receptor antagonist or GRA program, also known as LGD-6972.
最後,我將簡要介紹一下我們的內部管道,特別是我們的胰高血糖素受體拮抗劑或 GRA 項目,也稱為 LGD-6972。
We completed enrollment into our Phase II trial in February, and are on track to have data in September.
我們於 2 月份完成了 II 期試驗的註冊,並有望在 9 月份獲得數據。
We've been pleased with the conduct and progression of the trial thus far, as we initiated this trial -- this Phase II trial in September of last year, and are on track to have the data within a year from when we started the trial.
到目前為止,我們對試驗的進行和進展感到滿意,因為我們於去年 9 月啟動了這項試驗——第二階段試驗,並且有望在試驗開始後一年內獲得數據。
We're excited about the program and believe we have what could be a first-in-class and/or best-in-class molecule for a novel mechanism of treating diabetes.
我們對該計劃感到興奮,並相信我們擁有可能成為治療糖尿病新機制的一流和/或一流分子。
I note that the landscape in the GRA space continues to evolve.
我注意到 GRA 領域的格局在不斷發展。
Lilly and Pfizer have attempted to develop small molecules, and glucagon also remains a target of interest in diabetes with other therapeutic approaches, too, with Ionis progressing an antisense program; and Pfizer beginning early work on a Phase I-stage antibody targeted at the glucagon receptor.
禮來(Lilly)和輝瑞(Pfizer)已嘗試開發小分子,胰高血糖素也仍然是其他治療方法對糖尿病感興趣的目標,Ionis 正在推進反義項目;輝瑞公司開始針對胰高血糖素受體的 I 期抗體的早期研究。
We believe that we may have a best-in-class and highly differentiated small molecule compared to prior molecules that were tested clinically.
我們相信,與之前經過臨床測試的分子相比,我們可能擁有同類最佳且高度差異化的小分子。
We're excited to see our Phase II data in September and expect to talk more about the various differentiating technical features of LGD-6972 at the right time.
我們很高興在 9 月份看到 II 期數據,並期望在適當的時候更多地討論 LGD-6972 的各種差異化技術特性。
And with that, I'll turn the call over to Matt Korenberg to discuss the financials.
接下來,我會將電話轉給馬特·科倫伯格 (Matt Korenberg),討論財務狀況。
Matthew Korenberg - Executive VP of Finance & CFO
Matthew Korenberg - Executive VP of Finance & CFO
Thanks, Matt.
謝謝,馬特。
I'll start my remarks today with financial highlights from our earnings release.
我今天將以我們財報發布的財務要點開始我的講話。
Total revenues for the first quarter of 2017 were $29.3 million and included royalty revenue of $24.2 million.
2017 年第一季度的總收入為 2,930 萬美元,其中特許權使用費收入為 2,420 萬美元。
Royalty revenue increase to 68% versus the year-ago period reflects higher Promacta and Kyprolis royalties as well as the addition of the EVOMELA and CorMatrix royalties.
特許權使用費收入較去年同期增長 68%,反映出 Promacta 和 Kyprolis 特許權使用費的增加以及 EVOMELA 和 CorMatrix 特許權使用費的增加。
Captisol material sales for Q1 were $1.1 million, and license fees and milestones for Q1 $3.9 million.
第一季度 Captisol 材料銷售額為 110 萬美元,第一季度的許可費和里程碑費用為 390 萬美元。
As John mentioned, our corporate gross margins were almost 99% this quarter.
正如約翰提到的,本季度我們公司的毛利率幾乎為 99%。
Our royalty revenue and our license and milestone fees are reported net on the revenue line with a 100% gross margins.
我們的特許權使用費收入以及許可費和里程碑費用均按收入線淨額報告,毛利率為 100%。
For the year, we continue to expect overall corporate gross margins in the mid-'90s, as we look for material sales to be a larger portion of revenue mix for the balance of the year as compared to Q1.
今年,我們繼續預計企業整體毛利率將在 90 年代中期,因為我們預計材料銷售將比第一季度在今年餘下的收入組合中佔據更大的比例。
On the expense side, our cash, R&D and G&A expense came right in line with our expectations at just under $10 million this quarter.
在費用方面,本季度我們的現金、研發和一般行政費用略低於 1000 萬美元,與我們的預期相符。
This quarter was expected to be heavier compared to the balance of the year, due primarily to the ongoing GRA trial and completion of enrollment.
預計本季度的情況將比今年剩餘時間更嚴重,這主要是由於正在進行的 GRA 試驗和註冊完成。
For the full year, we continue to be on track for $28 million to $30 million of cash expenses.
全年,我們仍有望實現 2800 萬至 3000 萬美元的現金支出。
Turning to cash flow.
轉向現金流。
Our cash flow from operations for the quarter was $24.2 million, and we continue to track towards $96 million of EBITDA, assuming our guidance for core revenue of $130 million as achieved.
本季度我們的運營現金流為 2420 萬美元,假設我們實現了 1.3 億美元的核心收入指引,我們將繼續朝著 9600 萬美元的 EBITDA 目標邁進。
And we continue to pay less than 1% cash taxes.
我們繼續繳納低於 1% 的現金稅。
But for both GAAP and adjusted income purposes, we show a fully taxed net income.
但出於公認會計準則和調整後收入的目的,我們顯示了全額納稅的淨利潤。
For the quarter, we reported adjusted net income of $12.6 million or $0.57 per diluted share, and we had GAAP net income of $5.1 million or $0.22 per diluted share.
本季度,我們公佈的調整後淨利潤為 1260 萬美元,即稀釋後每股收益 0.57 美元,GAAP 淨利潤為 510 萬美元,即稀釋後每股收益 0.22 美元。
One quick comment on the GAAP earnings.
對 GAAP 收益的簡要評論。
This quarter will
本季度將
(technical difficulty)
(技術難度)
one of the larger items that impacted GAAP earnings related to stock-based comp associated with the OMT transaction.
影響 GAAP 收益的較大項目之一與 OMT 交易相關的基於股票的補償有關。
As previously disclosed, as part of our transaction to acquire OMT and the OmniAb technology, we issued a sizable equity-retention package to the OmniAb scientific founder and employees that we brought into the Ligand fold.
正如之前披露的,作為我們收購 OMT 和 OmniAb 技術交易的一部分,我們向 OmniAb 科學創始人和我們納入配體業務的員工發放了相當大的股權保留包。
We're pleased to report that the OmniAb business continues to outperform our former expectations and, as such, the employees of OMT earned a portion of their equity rents this past quarter by achieving performance goals.
我們很高興地報告,OmniAb 業務繼續超出我們之前的預期,因此,OMT 的員工在上個季度通過實現績效目標賺取了部分股權租金。
Specifically, there was a $2.5 million charge for the vesting of those shares that was booked to R&D in Q1.
具體來說,第一季度計入 R&D 的這些股份的歸屬費用為 250 萬美元。
With the transaction having closed in early 2016, these type of incentive payments were structured to run 2 years and should end in 2017.
由於交易已於 2016 年初完成,此類獎勵支付的期限為 2 年,應於 2017 年結束。
On the balance sheet, we ended the quarter with just over $159 million of cash and investments.
在資產負債表上,本季度末我們的現金和投資略高於 1.59 億美元。
And now turning to guidance.
現在轉向指導。
We continue to see solid revenue growth for 2017 and our guidance is unchanged.
我們繼續看到 2017 年收入穩健增長,我們的指導不變。
Our core revenue estimate continues to assume about $87 million of royalties, about $23 million of material sales and at least $20 million of milestones and license fees.
我們的核心收入估計繼續假設約 8700 萬美元的特許權使用費、約 2300 萬美元的材料銷售以及至少 2000 萬美元的里程碑和許可費。
With respect to the upside on milestones, we still see $24 million of potential upside for the balance of the year, in addition to the $20 million of core milestone revenue.
至於里程碑的上升空間,除了 2000 萬美元的核心里程碑收入之外,我們仍然認為今年剩餘時間還有 2400 萬美元的潛在上升空間。
This range of upside's tied to over 20 events, mostly of a clinical and regulatory nature that are impossible to predict the outcomes of until more information comes in.
這一範圍的上漲與 20 多個事件有關,其中大部分是臨床和監管性質的事件,在獲得更多信息之前無法預測其結果。
Adjusted earnings per diluted share at the $130 million level is still projected to be $2.70, and each additional million dollars of revenue generates about $0.025 to $0.03 a share in EPS.
按 1.3 億美元水平計算的調整後每股攤薄收益預計仍為 2.70 美元,每增加 100 萬美元收入,每股收益將產生約 0.025 至 0.03 美元。
Lastly, I'll address a few other accounting topics.
最後,我將討論一些其他會計主題。
Regarding ASC 606, the new revenue recognition guidance that will be widely implemented by all companies in 2018, we continue to make good progress in evaluating the potential impact to Ligand.
關於ASC 606,即2018年所有公司將廣泛實施的新收入確認指南,我們在評估對Ligand的潛在影響方面繼續取得良好進展。
We're continuing to go through each of our contracts with our partners in determining the change, if any, under the new guidance.
我們將繼續審查與合作夥伴簽訂的每份合同,以確定根據新指導方針進行的變更(如果有)。
As mentioned in our previous disclosures, we expect the primary impact for Ligand to involve an acceleration in timing of the recognition of our royalty revenue by 1 quarter.
正如我們之前披露的那樣,我們預計對 Ligand 的主要影響包括將我們的特許權使用費收入確認時間提前 1 個季度。
We do not expect the guidance to have much impact to our materials revenue on our milestone and license fee revenue.
我們預計該指導不會對我們的里程碑材料收入和許可費收入產生太大影響。
The other accounting topic I wanted to comment on relates to our CyDex CVR payments.
我想評論的另一個會計主題與我們的 CyDex CVR 付款有關。
As investors in Ligand well are aware, we acquired CyDex and their Captisol technology in 2011, and since that time, we've shared a portion of CyDex-related revenue over certain thresholds with the former CyDex shareholders.
Ligand 的投資者都清楚,我們於 2011 年收購了 CyDex 及其 Captisol 技術,從那時起,我們就與前 CyDex 股東分享了超過一定閾值的部分 CyDex 相關收入。
We made our last revenue sharing payment to CyDex in the first quarter and, going forward, will benefit from 100% of the revenue related to CyDex, other than specific CVR payments tied to our clopidogrel and topiramate programs.
我們在第一季度向 CyDex 支付了最後一筆收入分成付款,今後,除了與我們的氯吡格雷和托吡酯項目相關的特定 CVR 付款外,我們將受益於與 CyDex 相關的 100% 收入。
As a result, starting in 2017, we'll benefit from improved cash flow from our Captisol material sales and other CyDex-related revenue streams.
因此,從 2017 年開始,我們將受益於 Captisol 材料銷售和其他 CyDex 相關收入流帶來的現金流改善。
Finally, as a reminder, our adjusted diluted EPS guidance excludes stock-based compensation expense, noncash debt-related costs, changes in contingent liabilities, transactions related -- transaction-related purchase price amortization, pro rata net losses of Viking Therapeutics as well as fair value adjustments to our holdings in our common stock, convertible note receivable and warrants, and mark-to-market adjustments for amounts owed to licensors, and the excess convert shares covered by bond hedge and certain one-time non-recurring items.
最後,提醒一下,我們調整後的稀釋後每股收益指引不包括股票補償費用、非現金債務相關成本、或有負債的變化、交易相關——交易相關購買價格攤銷、Viking Therapeutics 按比例淨虧損以及對我們持有的普通股、應收可轉換票據和認股權證進行公允價值調整,對欠許可人的金額進行按市價調整,以及債券對沖和某些一次性非經常性項目所涵蓋的超額可轉換股票。
With that, I'll turn the call back over to the operator and open it up for questions.
這樣,我會將電話轉回給接線員並打開詢問問題。
Operator
Operator
(Operator Instructions) Our first question comes from the line of Drew Jones with Stephens.
(操作員說明)我們的第一個問題來自德魯·瓊斯和斯蒂芬斯的線路。
Andrew Luten Jones - MD
Andrew Luten Jones - MD
First on Captisol, just trying to figure out maybe the cadence for the rest of the year, how heavily weighted towards the back end of the year that should be.
首先是 Captisol,只是想弄清楚今年剩餘時間的節奏,以及今年年底的權重應該有多大。
And then, I guess, kind of a part B to the question, are there any take-or-pay components to some of the contracts you have for Captisol out there?
然後,我想,問題的 B 部分是,你們為 Captisol 簽訂的一些合同是否有任何照付不議的組成部分?
Matthew Korenberg - Executive VP of Finance & CFO
Matthew Korenberg - Executive VP of Finance & CFO
Andrew, it's Matt.
安德魯,是馬特。
Generally speaking, Captisol has traditionally been a Q4-heavily weighted business, and similar to last year, we continue to expect second half to be heavier than the first half and Q4 to be heavier than Q3.
總體而言,Captisol 傳統上是第四季度的重倉業務,與去年類似,我們繼續預計下半年將重於上半年,第四季度將重於第三季度。
So I think our assumption is we'll see sort of a steady growth over the next couple of quarters and then a bigger Q4.
因此,我認為我們的假設是,我們將在接下來的幾個季度看到穩定增長,然後是第四季度更大的增長。
Matt, do you want to comment on other Captisol dynamics?
Matt,您想對 Captisol 的其他動態發表評論嗎?
Matthew W. Foehr - President & COO
Matthew W. Foehr - President & COO
Yes -- no, there are elements, Drew, to the second part of your question, for some contracts that will have binding and non-binding windows when people graduate to commercial stage.
是的——不,德魯,對於你問題的第二部分,有些合同在人們進入商業階段時將具有約束力和非約束力的窗口。
But on the clinical stage, obviously, the orders can be lumpy as people start-up trials or have meetings with the FDA that define the design of their preclinical or clinical trial, so there's still little a lumpy element to it.
但在臨床階段,顯然,當人們啟動試驗或與 FDA 舉行會議來定義其臨床前或臨床試驗的設計時,訂單可能會很不穩定,因此仍然沒有什麼不穩定的因素。
Andrew Luten Jones - MD
Andrew Luten Jones - MD
Perfect.
完美的。
And then second question, just on R&D as it relates to the GRA trial.
然後是第二個問題,關於與 GRA 試驗相關的研發。
Are we still thinking kind of $8 million to $10 million in spend related to that this year?
我們是否仍在考慮今年與此相關的 800 萬至 1000 萬美元支出?
Is that the right level?
這是正確的水平嗎?
Matthew Korenberg - Executive VP of Finance & CFO
Matthew Korenberg - Executive VP of Finance & CFO
Yes.
是的。
So the total trial was $8 million to $10 million over the course of -- from we started it and through the balance of this year.
因此,從我們開始到今年剩餘時間,整個試驗的總成本為 800 萬至 1000 萬美元。
So most of that will happen in this year, but some of it was last year.
所以大部分都將在今年發生,但其中一些是去年發生的。
Operator
Operator
Our next question comes from line of Scott Henry with Roth Capital.
我們的下一個問題來自斯科特·亨利(Scott Henry)與羅斯資本(Roth Capital)的對話。
Scott Robert Henry - MD, Senior Research Analyst & Head of Pharmaceuticals Research
Scott Robert Henry - MD, Senior Research Analyst & Head of Pharmaceuticals Research
Question -- a couple of questions.
問題——幾個問題。
First, to follow-on the R&D comment, how should we think about sequential changes in R&D?
首先,跟進研發評論,我們應該如何看待研發的連續變化?
I mean, should 2Q be elevated as well?
我的意思是,2Q 也應該升高嗎?
Or -- I'm just trying to sense how the pattern of R&D should be throughout the year.
或者——我只是想了解全年的研發模式應該如何。
Matthew Korenberg - Executive VP of Finance & CFO
Matthew Korenberg - Executive VP of Finance & CFO
The R&D number really will be more heavily weighted as it relates to the trial for Q1, and that's really the bulk of the budget in terms of -- or certainly the biggest line item in the budget for the year.
研發數字確實會受到更大的權重,因為它與第一季度的試驗相關,這實際上是預算的大部分——或者肯定是今年預算中最大的項目。
And so if you're talking about quarter-over-quarter this year, I'd expect the balance of the year to be roughly similar for the -- each of the remaining 3 quarters, so spread evenly for the rest of the 3 quarters.
因此,如果你談論的是今年的季度環比,我預計今年剩餘 3 個季度的餘額將大致相似,因此在剩餘 3 個季度中均勻分佈。
Scott Robert Henry - MD, Senior Research Analyst & Head of Pharmaceuticals Research
Scott Robert Henry - MD, Senior Research Analyst & Head of Pharmaceuticals Research
Okay, great.
好的,太好了。
That is helpful.
這很有幫助。
And then, with regards to the Retrophin or Sparsentan trial, do you receive a milestone when that trial is started?
然後,關於 Retropin 或 Sparsentan 試驗,當試驗開始時,您是否收到了里程碑?
And similar question, how should we think about milestone payments throughout the year?
類似的問題是,我們應該如何考慮全年的里程碑付款?
Matthew W. Foehr - President & COO
Matthew W. Foehr - President & COO
Yes, Scott, I can comment on that.
是的,斯科特,我可以對此發表評論。
Matt can probably add a little more color.
馬特可能可以添加更多顏色。
There is a milestone payment associated with Phase III initiation, so that was disclosed recently.
最近披露了與第三階段啟動相關的里程碑付款。
So there is a milestone payment associated with Phase III start of the Retrophin Sparsentan trial.
因此,Retropin Sparsentan 試驗的 III 期啟動相關的里程碑付款。
Matthew Korenberg - Executive VP of Finance & CFO
Matthew Korenberg - Executive VP of Finance & CFO
Yes.
是的。
And in terms of milestone pacing for the year, it's the same answer.
就今年的里程碑進度而言,答案是相同的。
We don't have as much control or visibility into when the timing of those milestones are going to happen, but we do expect a bit more in Q4 this year than we do in the other quarters, sort of similar to last year.
對於這些里程碑何時發生,我們沒有太多的控制權或可見性,但我們確實預計今年第四季度會比其他季度多一些,與去年類似。
Scott Robert Henry - MD, Senior Research Analyst & Head of Pharmaceuticals Research
Scott Robert Henry - MD, Senior Research Analyst & Head of Pharmaceuticals Research
Okay.
好的。
And can you remind me the amount for that Phase III initiation milestone?
您能提醒我第三階段啟動里程碑的金額嗎?
Matthew W. Foehr - President & COO
Matthew W. Foehr - President & COO
Yes.
是的。
The milestone itself is $1.6 million to Ligand.
這一里程碑本身為 Ligand 帶來了 160 萬美元。
There's a portion that we owe to BMS, given their heritage with the program, but it's $1.6 million to Ligand.
鑑於 BMS 在該項目上的傳統,我們欠一部分錢,但其中有 160 萬美元是給 Ligand 的。
Scott Robert Henry - MD, Senior Research Analyst & Head of Pharmaceuticals Research
Scott Robert Henry - MD, Senior Research Analyst & Head of Pharmaceuticals Research
Okay.
好的。
And then, final question, which is sort of a big-picture question.
然後是最後一個問題,這是一個大局問題。
Obviously, there's so much going on in the pipeline.
顯然,還有很多事情正在醞釀之中。
If you were going to highlight 1 or 2 things that kind of jump out that -- to make sure we're focusing on where we should be, because there is a lot, what will be the key, kind of takeaways that you would have in your pipeline development where we should focus most of our attention to?
如果你要強調 1 或 2 件事,那麼要確保我們專注於我們應該做的事情,因為有很多,什麼是關鍵,你會得到什麼樣的收穫在你的管道開發中我們最應該關注哪些地方?
John L. Higgins - CEO & Executive Director
John L. Higgins - CEO & Executive Director
Scott, thanks, it's John.
斯科特,謝謝,我是約翰。
I'll add a comment.
我會添加評論。
Then Matt Foehr can remark as well.
然後 Matt Foehr 也可以發表評論。
Clearly, a lot of interest on a program you just asked about, Sparsentan and also SAGE's program.
顯然,您對您剛才詢問的一個程序——Sparsentan 和 SAGE 的程序很感興趣。
They're developing SAGE-547 for SRSE.
他們正在為 SRSE 開發 SAGE-547。
Both of these programs are very interesting.
這兩個節目都非常有趣。
There's good data out.
有很好的數據出來了
I think, a lot of clinical and regulatory momentum with the programs.
我認為,這些項目帶來了很多臨床和監管動力。
With Sparsentan, it's a 9% royalty.
Sparsentan 的特許權使用費為 9%。
It's a significant royalty, and it's an indication that has been described to have a potential for a fairly large market size.
這是一筆重要的特許權使用費,並且表明有相當大的市場規模的潛力。
So that's the data we saw the first time last fall and, obviously, we're monitoring closely, Retrophin's messaging about timing for when the next trial will start, but that is one -- SAGE-547, again, is very interesting.
這就是我們去年秋天第一次看到的數據,顯然,我們正在密切監視 Retropin 關於下一次試驗何時開始的時間信息,但這就是一個——SAGE-547,再次非常有趣。
It's being developed by a highly capable team at SAGE.
它是由 SAGE 的一支高素質團隊開發的。
Tremendous amount of clinical data has come out of it for SRSE, a coma-related indication, and also PTD.
針對 SRSE(一種昏迷相關適應症)以及 PTD,我們已獲得大量臨床數據。
Those are 2 that have garnered a lot of interest from institutional investors.
這兩個項目引起了機構投資者的極大興趣。
We have highlighted a few recent developments for their OmniAb program, and this is a substantial developing story.
我們重點介紹了他們 OmniAb 項目的一些最新進展,這是一個重要的發展故事。
We have over 23 partners.
我們有超過 23 個合作夥伴。
Each one has numerous antibodies in various stages of development.
每一種抗體都有大量處於不同發育階段的抗體。
This year, we're seeing several move into human testing.
今年,我們看到一些藥物進入人體測試。
And the eventual potential for any one of these programs, plus the royalty rate, makes these assets a really attractive and growing narrative for Ligand.
這些項目中任何一個的最終潛力,加上特許權使用費,使這些資產對 Ligand 來說成為真正有吸引力且不斷增長的敘述。
Although, they are still earlier stage.
儘管如此,它們仍處於早期階段。
So those are the 2 headlines, and I'll just turn it over to Matt to add a little more color.
這就是兩個標題,我將把它交給馬特來添加更多的色彩。
Matthew W. Foehr - President & COO
Matthew W. Foehr - President & COO
Yes, just as -- you were asking about kind of looking across the pipeline, and I'll say that the pipeline grows and progresses and it has been over the recent quarters.
是的,正如您所問的那樣,對整個管道進行審視,我會說管道在最近幾個季度不斷增長和進步。
It's really the diversity that starts to stand out, in many ways, too.
事實上,多樣性在很多方面也開始脫穎而出。
There are, obviously, a number of programs.
顯然,有很多程序。
John highlighted a couple that are exciting and there are a number of other ones emerging as well.
約翰強調了一些令人興奮的事情,還有一些其他的事情正在出現。
But as you look across the portfolio, the diversity of underlying technologies between Captisol, OmniAb, those that have underlying intellectual property associated with the NCE, as is the case with Sparsentan, those that came by way of the Selexis transactions, you really start to get a sense of that element of diversity, but also the diversity of therapy area as well and oncology and cardiometabolic, specialty Pharma as well as biosimilars, now that are starting to emerge and graduate and start to get a lot more attention as they become late stage.
但當你縱觀整個產品組合時,Captisol、OmniAb 之間基礎技術的多樣性,以及那些擁有與 NCE 相關的基礎知識產權的技術,就像 Sparsentan 的情況一樣,這些技術是通過 Selexis 交易獲得的,你真的開始意識到了解多樣性元素,以及治療領域以及腫瘤學和心臟代謝、專業製藥以及生物仿製藥的多樣性,現在這些藥物已經開始出現並畢業,並且隨著它們變得較晚而開始獲得更多關注階段。
I'll mention the Coherus program as an example.
我將提到 Coherus 程序作為示例。
So a number of those are starting to become more visible as well as, I'll say, the Lilly programs that utilize Captisol; the Prexasertib as well as merestinib, which is the small molecule MEK kinase inhibitor at Lilly, these are ones that we're starting to pay more attention to, internally.
因此,其中許多項目開始變得更加引人注目,我想說的是,禮來公司利用 Captisol 的項目; Prexasertib 以及禮來公司的小分子 MEK 激酶抑製劑 merestinib,這些是我們內部開始更加關注的藥物。
Operator
Operator
Our next question comes from the line of Matt Tiampo with Craig-Hallum.
我們的下一個問題來自馬特·蒂安波(Matt Tiampo)和克雷格·哈勒姆(Craig-Hallum)的對話。
Anthony Humphrey
Anthony Humphrey
This is Anthony Humphrey stepping in for Matt.
安東尼·漢弗萊 (Anthony Humphrey) 接替馬特 (Matt)。
First question is how many -- how has clinical progress and new projections from your customers in early part of this year influence your outlook for Captisol in fiscal year 2017?
第一個問題是,今年年初的臨床進展和客戶的新預測如何影響您對 Captisol 2017 財年的前景?
Matthew Korenberg - Executive VP of Finance & CFO
Matthew Korenberg - Executive VP of Finance & CFO
Yes.
是的。
Thanks, Anthony.
謝謝,安東尼。
We -- as we said, we still see Captisol right in line with where we did at Analyst Day when last week we gave our sort of our core revenue estimate, and also that the pattern that we see every year is sort of a back-end half of the year Q4 heavier buying from our customers, and so we expect to see that again this year as well.
正如我們所說,我們仍然認為 Captisol 與上週我們在分析師日所做的情況一致,當時我們給出了我們的核心收入預測,而且我們每年看到的模式在某種程度上是一種支持-今年第四季度末,客戶的購買量增加,因此我們預計今年也會再次出現這種情況。
So we're still right on track with Captisol.
所以我們在 Captisol 方面仍然處於正軌。
Anthony Humphrey
Anthony Humphrey
And are you able to give us an update on the progress of some of your OmniAb partners have made movements -- moving -- have made -- moving candidates into clinics?
您能否向我們介紹一些 OmniAb 合作夥伴的最新進展情況?他們已經採取行動,將候選人轉移到診所?
And any update on the number of products on the clinic at this point?
目前診所的產品數量有什麼更新嗎?
Matthew W. Foehr - President & COO
Matthew W. Foehr - President & COO
Yes, thank you.
是的,謝謝。
This is Matt Foehr.
這是馬特·弗爾。
The folks at J&J Janssen have moved a Phase I candidate into the clinic.
強生楊森 (J&J Janssen) 的工作人員已將一期候選藥物轉移到診所。
So that -- we are obviously pleased with that progression.
因此,我們顯然對這一進展感到滿意。
We also have a couple of others that are in the clinic now through a Chinese partner, so those are in the clinic in China.
我們現在還有其他幾個通過中國合作夥伴在診所裡的人,所以這些人都在中國的診所裡。
Genentech also has a Phase I program that entered into the clinic in recent months as well.
基因泰克還有一個一期項目,也在最近幾個月進入臨床。
I'll note, on that program that Genentech actually did an early deal with OMT prior to our acquisition of them, so they have a fully paid license.
我要指出的是,在該計劃中,基因泰克實際上在我們收購 OMT 之前就與他們達成了早期協議,因此他們擁有全額付款的許可證。
But from a technical perspective, it's been very good to see that program progressing well and began being highlighted at Genentech.
但從技術角度來看,很高興看到該項目進展順利並開始在基因泰克受到重視。
Also, I'll just briefly mention Aptevo, which is the newest named Captisol -- or sorry, named OmniAb antibody that is now progressing its preclinical at this point, but they highlighted some very impressive data on an antibody that was pulled out of OmniMouse at the PEGS conference last week in Boston.
另外,我只想簡單提一下 Aptevo,這是最新的名為 Captisol 的抗體,或者抱歉,名為 OmniAb 抗體,目前正在進行臨床前研究,但他們強調了從 OmniMouse 中提取的抗體的一些非常令人印象深刻的數據上週在波士頓舉行的 PEGS 會議。
Anthony Humphrey
Anthony Humphrey
Great.
偉大的。
And then, last question is what is your take on the path for RTRX and Sparsentan?
最後一個問題是您對 RTRX 和 Sparsentan 的發展道路有何看法?
Any insight into what the timeline might look like?
對時間表可能是什麼樣子有什麼了解嗎?
And what do you think the additional indicators they may be pursuing might include?
您認為他們可能追求的額外指標可能包括哪些?
Matthew W. Foehr - President & COO
Matthew W. Foehr - President & COO
Yes.
是的。
Thanks, Anthony.
謝謝,安東尼。
Obviously, we talked a little bit about Sparsentan in prepared remarks and the folks at Retrophin gave an update that they are finalizing the Phase III protocol right now with the FDA.
顯然,我們在準備好的發言中討論了一些關於 Sparsentan 的問題,Retropin 的人員更新了他們目前正在與 FDA 敲定 III 期協議的最新消息。
We'll be doing that in the second half of the year and they expect to start Phase III near the end of the year.
我們將在今年下半年這樣做,他們預計將在今年年底啟動第三階段。
You're going to bring up -- at the -- it's a good point.
你會提出——在——這是一個很好的觀點。
At their call last week, they talked about -- the folks at Retrophin talked about other potential indications for Sparsentan downstream of FSGS.
在上週的電話會議上,Retropin 的人員談到了 FSGS 下游的 Sparsentan 的其他潛在適應症。
We really don't have a lot more information on what those indications are.
我們確實沒有更多關於這些跡象的信息。
I think it's safe to say there are a number of glomerular nephropathies where Sparsentan could play an important role.
我認為可以肯定地說,Sparsentan 可以在許多腎小球腎病中發揮重要作用。
So we'll keep an eye and ear out on Retrophin's disclosures there as they explore other indications.
因此,當他們探索其他適應症時,我們將密切關注 Retropin 的披露。
Operator
Operator
Our next question comes from the line of Esther Rajavelu with Deutsche Bank.
我們的下一個問題來自德意志銀行的 Esther Rajavelu。
Esther P. Rajavelu - Former Research Analyst
Esther P. Rajavelu - Former Research Analyst
This is Esther Rajavelu for Greg Gilbert.
我是格雷格·吉爾伯特的埃絲特·拉賈維魯。
I had a quick question on the performance of CorMatrix and Carnexiv in the first quarter.
我對 CorMatrix 和 Carnexiv 第一季度的表現有一個簡短的問題。
Where are they trending relative to your expectations?
相對於您的預期,它們的趨勢如何?
John L. Higgins - CEO & Executive Director
John L. Higgins - CEO & Executive Director
So I heard CorMatrix.
所以我聽到了CorMatrix。
On CorMatrix, the -- they're right on expectations.
在 CorMatrix 上,他們的預期是正確的。
They continue to commercialize the business in a way that is right in line with our expectations.
他們繼續以符合我們期望的方式將業務商業化。
And on Carnexiv, I'll turn it over to Matt.
在 Carnexiv 上,我會將其交給 Matt。
Matthew W. Foehr - President & COO
Matthew W. Foehr - President & COO
Yes, so Carnexiv, a drug that's approved, Captisol-enabled drug.
是的,所以 Carnexiv,一種已獲批准的藥物,具有 Captisol 功能的藥物。
Lundbeck got approval in October of last year.
Lundbeck於去年10月獲得批准。
We're still awaiting an update from them on launch.
我們仍在等待他們的發布更新。
They were getting some supply chain elements ready prior to launch.
他們在發布之前準備了一些供應鏈要素。
So that's still pending launch.
所以這仍然有待推出。
John L. Higgins - CEO & Executive Director
John L. Higgins - CEO & Executive Director
Thank you.
謝謝。
Well, we appreciate the people's turnout and interest in our call today.
嗯,我們感謝人們對我們今天的電話會議的參與和興趣。
Apologize, we'll work with the operator.
抱歉,我們會與接線員合作。
Not sure what happened in the early minutes of the call, and just want to acknowledge those who were disrupted by that.
不知道通話的前幾分鐘發生了什麼,只是想向那些被此事打擾的人表示感謝。
We'll look into it.
我們會調查一下。
We have a couple of conferences coming up.
我們即將召開幾場會議。
May 31, we'll be at the Craig-Hallum conference in Minneapolis with investors.
5 月 31 日,我們將與投資者一起參加在明尼阿波利斯舉行的 Craig-Hallum 會議。
And then, a week later we'll be in New York City presenting at the Jefferies conference on June 8 -- I'm sorry, June 7 -- June 8th.
然後,一周後,我們將在 6 月 8 日在紐約市的 Jefferies 會議上發表演講——對不起,是 6 月 7 日——6 月 8 日。
The conference is the 7th and 8th.
此次會議已是第七屆、第八屆。
Anyhow, we do appreciate your interest and turnout, and we look forward to keeping you updated as the year progresses.
無論如何,我們非常感謝您的關注和參與,我們期待著隨著時間的推移向您通報最新情況。
Thank you very much.
非常感謝。
Operator
Operator
This concludes today's teleconference.
今天的電話會議到此結束。
You may disconnect your lines at this time, and thank you for your participation.
此時您可以斷開線路,感謝您的參與。